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What run? GSK agreed to buy for 75 a share. Not going any higher. Buy now hold till feb when deal is complete, and collect your buck fifty profit. Lol
Winning!!!!!
DEC. 21, 75$ call is a good buy real cheap!
Pretty chart from early August up to today. It surely illustrates patience. Rarely do I have the patience to remain in that long. Congratulations.
TSRO
You would have been green!!!... Patience my son
Sold near EOD @ $35.26 for sizable loss, but glad I decided to sell. Stock was a big disappointment, analysts be dammed. They need to change their far to bullish analyses. Suppose will after the earnings call.
TSRO
Tsaro Announces Availability of Zejula™ (Niraparib) for Patients With Recurrent Ovarian Cancer in the U.S.
* ZEJULA is the first and only PARP inhibitor to be approved for the maintenance treatment of women with recurrent ovarian cancer
* ZEJULA is the only PARP inhibitor that has demonstrated a clinically meaningful increase in PFS regardless of BRCA mutation or biomarker status
WALTHAM, Mass., April 19, 2017 (GLOBE NEWSWIRE) -- TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced that ZEJULA™ (niraparib), an oral, once-daily poly(ADP-ribose) polymerase (PARP) inhibitor, is now available by prescription in the United States. The U.S. Food and Drug Administration (FDA) approved ZEJULA on March 27, 2017 for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response (CR or PR) to platinum-based chemotherapy. The National Comprehensive Cancer Network (NCCN) recently added ZEJULA to the NCCN Clinical Practice Guidelines in Oncology Ovarian Cancer version 1.2017—April 12, 2017—as maintenance therapy for patients with platinum-sensitive disease who are in partial or complete response after completion of two or more lines of platinum-based therapy.
"TESARO is committed to the responsible development and commercialization of transformative therapies for people bravely facing cancer, and we are proud to bring ZEJULA to women who until today had limited treatment options," said Lonnie Moulder, CEO of TESARO. "Increasing progression-free survival after platinum therapy is a truly meaningful benefit for patients and their families, and the once-daily, individualized dosing of ZEJULA allows healthcare providers to ensure the optimal dose per patient without compromising efficacy. We are committed to ensuring access for patients through TOGETHER with TESARO, our patient assistance program for ZEJULA, and we look forward to delivering this important new treatment option to patients and their caregivers."
ZEJULA is the only PARP inhibitor that has demonstrated a clinically meaningful increase in progression-free survival (PFS) in women with recurrent ovarian cancer, regardless of BRCA mutation or biomarker status, in a randomized, prospectively designed Phase 3 clinical trial. ZEJULA offers oral, once-daily dosing, enabling convenient administration for maintenance treatment. FDA approval of ZEJULA is based upon data from the international Phase 3 ENGOT-OV16/NOVA trial, a double-blind, placebo-controlled study that enrolled 553 patients with recurrent ovarian cancer who had achieved either a PR or CR to their most recent platinum-based chemotherapy. Approximately two-thirds of study participants did not have germline BRCA mutations. Progression in the NOVA study was determined by robust, unbiased, blinded central review, to be the earlier of radiographic or clinical progression. ZEJULA significantly increased PFS in patients with and without germline BRCA mutations as compared to control. Treatment with ZEJULA reduced the risk of disease progression or death by 74% in patients with germline BRCA mutations (HR 0.26) and by 55% in patients without germline BRCA mutations (HR 0.45). The magnitude of benefit was similar for patients entering the trial with a PR or a CR.
The most common grade 3/4 adverse reactions to ZEJULA in the NOVA trial included thrombocytopenia (29%), anemia (25%), neutropenia (20%), and hypertension (9%). The majority of hematologic adverse events were successfully managed via dose modification, and discontinuation of therapy due to thrombocytopenia, neutropenia and anemia occurred in 3.3%, 1.9% and 1.4% of patients, respectively. Following dose adjustment based on individual tolerability, the incidence of grade 3/4 thrombocytopenia was low; approximately <1% after month 2. Please see the "Select Important Safety Information" below for warnings, precautions and adverse events.
"Women with recurrent ovarian cancer often experience considerable fear and anxiety about future recurrences," said Audra Moran, President and CEO of Ovarian Cancer Research Fund Alliance. "ZEJULA may offer patients and their families a treatment option during this stressful period. The ovarian cancer community is eager for new treatment options, and we are glad that ZEJULA will be available to women that have completed their platinum-based chemotherapy."
The Wholesale Acquisition Cost (WAC) of ZEJULA is $9,833 for a one-month supply of ZEJULA at a dose of 200 milligrams once per day, the most commonly administered dose over the course of the Phase 3 NOVA clinical trial. The approved starting dose of ZEJULA is 300 milligrams once per day.
TESARO is committed to ensuring access to ZEJULA. The Company's patient assistance program, TOGETHER with TESARO™, is a reflection of TESARO's commitment to the patient community and includes comprehensive services such as commercial copay assistance, assistance for the uninsured or underinsured, and access to other organizations that support ovarian cancer patients, among others.
About TOGETHER with TESARO™
TOGETHER with TESARO™ is a patient resource program dedicated to supporting people living with cancer. The program assists with access issues, so that patients with cancer can be free to focus on treatment goals and simply living life. It provides a full suite of services to meet each patient's needs and individual experience. A team of access and affordability experts is available to help oncology practices and patients gain access to the medication they require. TOGETHER with TESARO will continue to evolve and grow to meet provider and patient needs. For more information, please visit www.togetherwithtesaro.com or call 1-844-2TESARO (1-844-283-7276).
About Ovarian Cancer
Approximately 22,000 women are diagnosed with ovarian cancer each year in the United States, and more than 65,000 women are diagnosed annually in Europe. Ovarian cancer is the fifth-most frequent cause of cancer death among women. Despite high response rates to platinum-based chemotherapy in the second-line advanced treatment setting, approximately 85% of patients will experience recurrence within two years. Per NCCN guidelines, BRCA testing and genetic counseling remain important components of the medical workup for all patients upon a diagnosis with ovarian cancer.
About the ZEJULA™ (Niraparib) ENGOT-OV16/NOVA Clinical Trial
ENGOT-OV16/NOVA was a double-blind, placebo-controlled, international Phase 3 trial of niraparib that enrolled 553 patients with recurrent ovarian cancer who were in a response to their most recent platinum-based chemotherapy. Patients were enrolled into one of two independent cohorts based on germline BRCA mutation status. One cohort enrolled patients who were germline BRCA mutation carriers (gBRCAmut), and the second cohort enrolled patients who were not germline BRCA mutation carriers (non-gBRCAmut) and included patients with HRD-positive and HRD-negative tumors. Within each cohort, patients were randomized 2:1 to receive niraparib or placebo and were treated continuously with placebo or 300 milligrams of niraparib, dosed as three 100 milligram tablets once per day, until progression. The primary endpoint of this study was progression-free survival (PFS). Secondary endpoints included patient-reported outcomes, chemotherapy-free interval length, PFS 2, overall survival, and other measures of safety and tolerability. More information about this trial is available at clinicaltrials.gov/show/NCT01847274.
Among patients who were germline BRCA mutation carriers, the niraparib arm successfully achieved statistical significance over the control arm for the primary endpoint of PFS, with a hazard ratio of 0.26 (95% CI, 0.173-0.410). The median PFS for patients treated with niraparib was 21.0 months, compared to 5.5 months for control (p<0.0001). Niraparib also showed statistical significance for patients in the non-germline BRCA mutant cohort. The niraparib arm successfully achieved statistical significance over the control arm for the primary endpoint of PFS, with a hazard ratio of 0.45 (95% CI, 0.338-0.607). The median PFS for patients treated with niraparib was 9.3 months, compared to 3.9 months for control (p<0.0001). Secondary endpoint analyses, including chemotherapy-free interval, time to first subsequent treatment, and PFS 2 were all statistically significant and favored niraparib over control for patients in both the gBRCAmut and non-gBRCAmut cohorts. Patient-reported outcome results from validated survey tools indicated that niraparib-treated patients reported no difference from control in measures associated with quality of life.
The full results of the ENGOT-OV16/NOVA trial were presented in detail at the European Society for Medical Oncology (ESMO) 2016 Congress in Copenhagen on October 8, 2016 by Dr. Mansoor Raza Mirza, M.D., Medical Director of the Nordic Society of Gynecologic Oncology (NSGO) and principal investigator. These data were simultaneously published in the New England Journal of Medicine.
Select Important Safety Information
Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML) was reported in patients treated with ZEJULA in all clinical studies. Discontinue ZEJULA if MDS/AML is confirmed.
Hematologic adverse reactions (thrombocytopenia, anemia and neutropenia) have been reported in patients treated with ZEJULA. Do not start ZEJULA until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). Monitor complete blood counts weekly for the first month, monthly for the next 11 months of treatment, and periodically after this time.
Hypertension and hypertensive crisis have been reported in patients treated with ZEJULA. Monitor blood pressure and heart rate monthly for the first year and periodically thereafter during treatment with ZEJULA. Closely monitor patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
Based on its mechanism of action, ZEJULA can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for six months after receiving the final dose. Because of the potential for serious adverse reactions in breastfed infants from ZEJULA, advise a lactating woman not to breastfeed during treatment with ZEJULA and for one month after receiving the final dose.
In clinical studies, the most common adverse reactions included: thrombocytopenia, anemia, neutropenia, nausea, constipation, vomiting, abdominal pain/distension, mucositis/stomatitis, diarrhea, fatigue/asthenia, decreased appetite, headache, insomnia, nasopharyngitis, dyspnea, rash and hypertension.
Please see full Prescribing Information for additional Safety Information at www.zejula.com.
Additional Clinical Trials of Niraparib
TESARO is building a robust niraparib franchise by assessing activity across multiple tumor types and by evaluating several potential combinations of niraparib with other therapeutics. The ongoing development program for niraparib includes a Phase 3 trial in patients who have received first-line treatment for ovarian cancer (the PRIMA trial) and a registrational Phase 2 trial in patients who have received multiple lines of treatment for ovarian cancer (the QUADRA trial). Several combination studies are also underway, including trials of niraparib plus pembrolizumab (the TOPACIO trial) and niraparib plus bevacizumab (the AVANOVA trial).
Additional trials of niraparib in ovarian, breast and lung cancers are planned. The studies will assess the effect of niraparib alone and in combination with other therapies, such as bevacizumab and an anti-PD-1 antibody, in a variety of treatment settings.
Janssen Biotech has licensed rights to develop and commercialize niraparib specifically for patients with prostate cancer worldwide, except in Japan.
About ZEJULA (Niraparib)
ZEJULA is an oral, once-daily poly(ADP-ribose) polymerase (PARP) 1/2 inhibitor that is indicated in the U.S. for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. The National Comprehensive Cancer Network (NCCN) recently added ZEJULA to the NCCN Clinical Practice Guidelines in Oncology Ovarian Cancer version 1.2017—April 12, 2017—as maintenance therapy for patients with platinum-sensitive disease who are in partial or complete response after completion of 2 or more lines of platinum-based chemotherapy. In preclinical studies, ZEJULA concentrates in the tumor relative to plasma, delivering greater than 90% durable inhibition of PARP 1/2 and a persistent antitumor effect.
About TESARO
TESARO is an oncology-focused biopharmaceutical company devoted to providing transformative therapies to people bravely facing cancer. For more information, visit www.tesarobio.com and follow us on Twitter and LinkedIn.
Forward Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding TESARO, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this release involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, risks associated with competition in the PARP market, risks related to pricing and reimbursement, risks related to manufacturing and supply, risks related to intellectual property, and other risks and uncertainties that could affect the availability or commercial potential of ZEJULA. TESARO undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see TESARO's Annual Report on Form 10-K for the year ended December 31, 2016.
Investor/Media Contact:
Jennifer Davis
Vice President, Corporate Affairs & Investor Relations
+1.781.325.1116 or jdavis@tesarobio.com
The FDA approved it.
March Presentation for Raymond James 38th Annual Institutional Investors Conference
http://ir.tesarobio.com/common/download/download.cfm?companyid=AMDA-Z6KN1&fileid=931439&filekey=E096DCC7-4B21-4285-A3AE-49BF1ECF7EE9&filename=March_2017_handouts_030617.pdf
TESARO's (TSRO) CEO Lonnie Moulder on Q4 2016 Results - Earnings Call Transcript
Q4 2016 Earnings Conference Call
February 28, 2017 04:15 PM ET
Executives
Jennifer Davis - IR
Lonnie Moulder - CEO
Tim Pearson - CFO
Mary Lynne Hedley - COO
Analysts
Alethia Young - Crédit Suisse
Peter Lawson - SunTrust
Seamus Fernandez - Leerink
Adnan Butt - RBC
Chris Raymond - Raymond James
Robyn Karnauskas - Citigroup
Andrew Barron - Morgan Stanley
Jim Birchenough - Wells Fargo
Boris Peaker - Cowen
Operator
Good afternoon, and welcome to the TESARO Fourth Quarter 2016 Conference Call. [Operator Instructions] As a reminder, this call is being recorded and webcast.
I'll now turn the call over to Jennifer Davis, Vice President of Investor Relations and Corporate Affairs at TESARO. Please go ahead.
Jennifer Davis
Thank you, Crystal. Good afternoon, and thank you for joining us today to discuss our recent business progress and TESARO's fourth quarter 2016 operating results. With me here today are CEO, Lonnie Moulder; our President and COO, Dr. Mary Lynne Hedley; and our CFO, Tim Pearson.
Earlier this afternoon, we issued a news release detailing our Q4 results. Please note that this news release and the slide presentation that we'll refer to during this conference call are both available in the Investors section of our website, www.tesarobio.com.
Before we begin, I'd like to remind you that discussions during this conference call will include forward-looking statements. These statements are subject to a number of risks and uncertainties that could cause our actual results to differ materially from those described in these forward-looking statements. We undertake no obligation to update or revise any forward-looking statements for any reason. The factors that could cause actual results to differ are discussed in the press release issued today; and in our SEC filings, including our annual report on Form 10-K for the year ended December 31, 2016, and quarterly report on Form 10-Q for the quarter ended September 30, 2016.
During today's call, we may refer to certain non-GAAP financial measures that involve adjustments to GAAP figures. These non-GAAP financial measures are not a substitute for GAAP financial measures and are unlikely to be comparable to non-GAAP information provided by other companies. We believe non-GAAP measures may be useful to investors as a supplement to but not as a substitute for the applicable GAAP number.
I'd now like to turn the call over to Lonnie Moulder, CEO of TESARO. Lonnie?
Lonnie Moulder
Thank you, Jen, and thank you, everyone, for joining us this afternoon. I'll make a few introductory remarks about our recent accomplishments, and we'll provide a brief update on VARUBI, niraparib prelaunch preparations and our international expansion. Tim will discuss our financial results. Mary Lynne will provide an update on our development programs and strategy and then we'll open up the call for questions.
2016 was an incredible year for TESARO, and during the fourth quarter, we continued to execute on our mission of responsibly developing and commercializing transformative therapies for patients with cancer. I'd like to start by highlighting several recent accomplishments. In the U.S., we have now completed the first full year of VARUBI oral launch, and we plan to expand our VARUBI franchise with the introduction of an IV formulation later this year. The launch of VARUBI in the U.S. enabled us to put the commercial infrastructure in place to support future product launches. Recently, we completed a targeted expansion of our field organization in order to launch niraparib. Our U.S. field-based team is now comprised of approximately 175 associates including territory managers, health systems managers, medical science liaisons, nurse educators and account managers, all with deep oncology experience that will enable TESARO to reach community and hospital-based health care providers. This team of associates is excited to bring niraparib to patients and we are prepared to launch this important product in the first half of 2017 in the U.S.
Our niraparib expanded access program initiated in the U.S. in January, so that women with recurrent ovarian cancer have access to niraparib during regulatory review. Work continues with European regulators so that patients in Europe can also potentially benefit from niraparib during the MAA review process and subsequent negotiations with health authorities. Our international organization continues to expand and by year-end should include approximately 130 associates, who are intent upon globalizing our mission. Currently, this team is enthusiastically preparing to launch VARUBI and niraparib in 17 European countries.
We recently received a positive CHMP opinion for VARUBI and subject to final approval and completion of pricing and reimbursement discussions; we plan to launch this product in Europe on a country-by-country basis beginning next quarter. Potential EMA approval of niraparib and the initial anticipated launch are planned for the end of 2017. We continue to make excellent progress across our development portfolio, highlighted by progress with our niraparib clinical development program and in advancing our immuno-oncology candidates in the clinic. Mary Lynne will speak in greater detail about these programs and our plans later on in the call.
In summary, 2017 is off to an excellent start. We are excited about the opportunities that lie ahead this year, and we look forward to four potential new product launches, VARUBI IV and niraparib in the U.S. and oral VARUBI and niraparib in Europe. Turning to VARUBI; we continue to hear positive feedback from clinicians regarding the benefits of VARUBI for the prevention of delayed chemotherapy-induced nausea and vomiting, in particular for patients with breast, lung and ovarian cancers, who receive emetogenic chemotherapy regimen. The launch of oral VARUBI was just the first step in our broader strategy to drive growth for this brand. The expected U.S. launch of VARUBI IV later this year will allow us to reach the vast majority of the U.S. market and over time, extend the use of NK-1 receptor antagonist to the majority of patients receiving emetogenic chemotherapy regimen as recommended by the NCCN Guidelines.
With that, I'll turn the call over to our CFO, Tim Pearson, for a review of our fourth quarter and full-year financial results. Tim?
Tim Pearson
Thank you, Lonnie. The fourth quarter saw a significant unit growth over the third quarter with over 9,100 commercial doses of VARUBI shift from specialty distributors and specialty pharmacies. VARUBI experienced increasing demand, new account orders and increased penetration at key large practices over the quarter.
We believe that approximately 20% of the fourth quarter unit volume relates to buying ahead of our anticipated year-end price increase. Absent the impact of these speculative purchases, our unit growth over Q3 was approximately 40%. As such, we expect sequential unit volume growth for the first quarter of 2017 to moderate, as this inventory is utilized.
TESARO reported total revenue of $4.2 million for the fourth quarter of 2016. Net product revenue recognized during the fourth quarter was $2.5 million and included shipments of VARUBI made during the quarter to patients through our specialty pharmacy and to providers through our network of specialty distributors.
License, collaboration and other revenue totaled $1.8 million for the fourth quarter and included amortization of upfront payments and shipments of clinical materials under our license agreements with Hengrui and Janssen.
Research and development expenses increased to $71.5 million for the fourth quarter of 2016 compared to $42.9 million for the fourth quarter of 2015. The increase was driven primarily by higher costs related to the ongoing registration trials of niraparib, manufacturing and other research and development costs related to niraparib, advancements of our immuno-oncology portfolio and increased headcount.
Selling, general and administrative expenses increased to $54.5 million for the fourth quarter of 2016 compared to $27.9 million for the comparable period of 2015, primarily due to commercial activities in support of the launch of VARUBI; prelaunch activities related to niraparib; expansion of European commercial organization; increased headcount; and higher professional service fees. Acquired in-process research and development expenses totaled $9 million for the fourth quarter of 2016 and included milestone payments related to niraparib.
For the fourth quarter of 2016, TESARO reported a net loss of $136.9 million compared to a net loss of $75.8 million for the fourth quarter of 2015. For the full year of 2016, TESARO reported revenue of $44.8 million. Net loss totaled $387.5 million for 2016 compared to a net loss of $251.4 million for 2015. The increase in net loss for the full year of 2016 was driven primarily by the same increases in cost as mentioned for Q4; commercial initiatives for VARUBI, expanded development program activities and growth in our workforce.
As of December 31, 2016, TESARO had approximately $786 million in cash and cash equivalents, which included approximately $224 million in net proceeds from a follow-on offering of common stock completed in November. For the first half of 2017, we expect that our cash and cash equivalents balance will decrease by approximately $110 million to $120 million per quarter on average, excluding one-time regulatory milestones, totaling $35 million that are expected to be paid at the time of the first commercial sale of VARUBI oral in Europe and approval of niraparib in the U.S. In anticipation of 4 potential new product launches in 2017, TESARO will invest in prelaunch inventory manufacturing and development of supply chain capabilities and capacity in addition to making milestone payments for regulatory submissions.
With that, I'll hand the call over to Mary Lynne.
Mary Lynne Hedley
Thank you, Tim. I'll now review each of our development programs, beginning with VARUBI. We have completed the review process with EMA and a few days ago, EMA's Committee for Medicinal Products for Human Use, or the CHMP, branded a positive opinion for VARUBI oral. Our first European approval represents an important milestone for TESARO and subject to final approval and completion of pricing and reimbursement discussions, we plan to launch this product in Europe on a country-by-country basis beginning next quarter.
In January, the FDA issued a complete response letter concerning the IV formulation of rolapitant. In the CRL, FDA requested additional information regarding the in vitro release method utilized to demonstrate comparability of drug product produced at the 2 proposed commercial manufacturers for rolapitant IV that were included in the NDA. We are working expeditiously to provide these data, and we continue to expect approval of rolapitant IV in the first half of this year.
Turning now to niraparib, our PARP inhibitor. In October of last year, we submitted the niraparib MAA and NDA. In December, the FDA accepted the NDA for niraparib and assigned it a priority review designation. The MAA also accepted the niraparib application for review, and both of these applications continue to advance through the process. As you know, these submissions are based upon the results from NOVA, which was the first data from a successful prospectively designed, randomized Phase III trial for a PARP inhibitor in any tumor type. NOVA was designed to evaluate a single daily oral dose of niraparib in patients with recurrent ovarian cancer and to definitively assess which patients could benefit from a PARP inhibitor.
As we announced last year, positive results were achieved and a statistical and clinically meaningful improvement in progression free survival, or PFS, was observed in patients regardless of BRAC mutation or HRD status. As such, our proposed indication for clinical use includes patients with recurrent ovarian cancer, regardless of biomarker status. Ovarian cancer is a dreadful disease, for which there have been few therapeutic advances made in the past decade. The effectiveness of platinum-based chemotherapy diminishes over time, and PFS and platinum-free intervals generally become shorter after each round of platinum therapy. As a result, women with recurrent ovarian cancer have limited treatment options and often experience considerable anxiety about future recurrences. We believe that extending the response to platinum provides a meaningful benefit for patients, who today have few treatment options.
In addition to the improvement in median PFS, from our perspective, the NOVA results were compelling in other ways. The niraparib treatment effect was consistent and durable for each of the primary population studied. For example, 18 months following randomization, which is approximately 24 months post initiation of chemotherapy, the proportion of patients with or without a germline BRCA mutation, who are alive and without disease progression, was 50% and 30%, respectively, for patients on niraparib compared to only 16% and 12%, for patients receiving control. The hazard ratio for PFS represents a relative risk reduction of progression of death of 73% for patients with germline BRCA mutation and 55% for patients without a germline BRCA mutation.
Importantly, the effects are durable even at two years post initiation of chemotherapy. Patient reported outcome status showed that niraparib did not reduce the body of life in comparison to patients receiving a placebo control. For a patient population whose median disease progression is shorter than a year from the time they start IV-based chemotherapy, we believe this represents a significant improvement and offers hope to patients, who previously may have had none.
Although less than 20% of events had occurred at the time of the NOVA unblinding, and overall survival data were immature, the hazard ratio was 0.73 in favor of niraparib. Anticipating that the survival data would be immature at the time of database lock, we assessed other end points to address two relevant questions about the impact of niraparib treatment. First, the treatment with niraparib reduced the benefit of the subsequent therapy. And second, with a positive effect of niraparib prolonged. Both of these questions can be addressed by an examination of the PFS2 data. As a reminder, PFS is measured from the time of randomization to disease progression, and PFS2 is measured from the time of randomization all the way to the second disease progression, which, of course, occurs following progression on both niraparib and subsequent therapy.
So to address the first question, does niraparib reduce the benefit of subsequent therapy? For each patient, the PFS interval is subtracted from PFS2. The data for the niraparib in the control populations were then compared and the results for the two groups were found to be identical, clearly demonstrating that niraparib treatment does not resolve in a decreased benefit from subsequent therapy. Details associated with these analyses will be presented at an upcoming medical meeting.
Now the second question, is the benefit of niraparib treatment sustained? To address this question, we also look at PFS2. At the time of the NOVA unblinding, the PFS2 data were also immature given the relatively long PFS that patients experienced on niraparib. Only 30% to 50% of events have been captured for patients in the germline BRCA-mutant and non-germline BRCA-mutant cohorts, respectively. In other words, the events that had been captured at that time were from those patients, who had progressed relatively early on niraparib or controlled treatment. Nevertheless, data for this secondary endpoint were compelling with a hazard ratio of 0.48 for patients with germline BRCA mutation and 0.69 for patients without germline BRCA mutation.
In summary, niraparib treatment does not reduce the benefit of subsequent therapy and the benefits are sustained beyond disease progression. We believe the benefit of niraparib beyond those with BRCA mutations is in part due to the unique characteristics of the special molecule that are described by nonclinical and clinical data.
In nonclinical study, niraparib was shown to be highly permeable, allowing it to concentrate in the tumor relative to plasma and delivered selective near complete sustained PARP inhibition and a persistent anti-tumor effect. One dose of niraparib provides greater than 90% PARP inhibition for up to 24 hours in the tumor and produces tumor regressions, where other PARP inhibitors do not. The high permeability of niraparib enables it to concentrate in tumors despite efflux pump, such as P-gp, which can cause resistance to other PARP inhibitors. In clinical studies, niraparib was shown to be highly bio-available, broadly distributed and slowly cleared.
The combination of these effects may be most relevant to producing clinically meaningful outcomes in a broad patient population, where the majority of patients do not have tumors with a BRCA mutation. And those tumors are inherently more difficult to kill with a PARP inhibitor. We believe that based on clear differences in the clinical pharmacology and chemical properties between PARP inhibitors, the clinical activity of one PARP inhibitor cannot be extrapolated across the class, particularly into patients without BRCA mutations.
Looking ahead, given the NOVA data, we view niraparib as a potential franchise opportunity and are advancing this promising drug in a broad development program that includes different lines of therapy in ovarian cancer and other tumor type. We plan to assess the activity of niraparib as a monotherapy as well as in combination with other anticancer agents. First, in ovarian cancer, as you know, we have two ongoing registration trials; PRIMA and QUADRA. PRIMA is a global randomized controlled trial being conducted with our partners, ENGOT and GOG; in which 330 patients with ovarian cancer who have achieved a response to their first line of platinum-based chemotherapy are randomized two-to-one to receive niraparib or placebo. Hierarchical testing schema will be used to assess the primary endpoint of PFS. PFS in the HRD-positive patient population will be assessed first and if that achieves statistical significance, then PFS in the entire population will be assessed.
Moving now to QUADRA; this trial is also enrolling a broad population of patients, whose disease has progressed after receiving multiple lines of chemotherapy, including patients previously treated with PARP inhibitors. We intend to enroll approximately 125 patients, who are HRD positive and another 125, who are HRD negative. We anticipate approximately 50 to 60 patients in the HRD-positive population will have a tumor BRCA mutation.
Our intent is to analyze the response and the duration of response in each of these populations and assuming the results are positive; submit an application for niraparib label expansion. We expect to have data from this study in the second half of 2017. Beyond ovarian cancer, patients with germline BRCA-mutated breast cancer are enrolling in the Phase III BRAVO trial. We expect data from this study in the second half of the year and the NDA and MAA submissions to follow shortly thereafter. Niraparib is also being evaluated in 2 combination trials that include patients with ovarian cancer.
The TOPACIO combination trial of niraparib plus pembrolizumab, an anti-PD-1 antibody, continues to enroll patients, who have either recurrent platinum-resistant ovarian cancer or triple-negative breast cancer. Patients with these tumors have demonstrated low response rates to anti-PD-1 and PARP inhibitor monotherapies, and we hope to improve upon the clinical activity with this combination approach. The dose escalation phase of this study has been completed, and we have initiated cohort expansion, which includes approximately 48 patients in each cohort. Patients in this study are accruing rapidly and will be assessed for tumor response and the duration of response. Early data from the trial are encouraging, and we anticipate reporting these data at an upcoming medical meeting.
The AVANOVA study, which is being conducted by our ENGOT collaborators, is evaluating the combination of niraparib plus the VEGF receptor inhibitor bevacizumab in patients with recurrent ovarian cancer. The dose escalation phase of this study is complete, and patients are currently being enrolled and randomized to niraparib versus niraparib plus bevacizumab in the expansion phase of the study. The primary endpoint is PFS. Initial data reported at ASCO indicate that for the 12 patients enrolled in part 1 of the study, the median duration of treatment was 41.7 weeks. We anticipate that updated data from this study will be reported in the second half of the year.
Finally, regarding expansion of the niraparib franchise into other tumor types, the NOVA data suggests that a common denominator for niraparib activity is a genetic background that enables response to platinum. Such tumor types include non-small lung cancer, bladder and head and neck cancer. Recently, clinical data has led to the approval or pending approval of agents that target the PD-1 and PD-L1 axis in these indications. While these agents are effective, combination with niraparib, potentially immunoactive agents that induce this durable effect may increase the number of responders and potentially duration of benefit to these agents.
Our development strategies will incorporate recent shifts in the treatment paradigm for these tumors such that data from potential registration studies of niraparib will continue to be relevant upon their completion. We are finalizing the designs now and intend to initiate clinical studies in certain of these tumors this year.
And finally, turning to our immuno-oncology program. We expect that immuno-oncology products, including antibodies directed to PD-1, TIM-3 and LAG-3, will become a foundation of cancer therapy regimens across a variety of tumor types. Having all 3 of these antibodies in our pipeline provides a competitive advantage and allows TESARO to be well positioned to collaborate with others who may have complementary approaches. The foundation of our work in immuno-oncology is currently focused on the presence of checkpoints on exhausted T-cells and on the common belief that immuno-oncology approaches may be most effective when used in combination.
Clinical data for the currently available anti-PD-1 antibodies shows a relatively low response rate for most unselected tumor type on the order of 15% to 30%. Upregulation of checkpoint such as TIM-3 expression on PD-1-positive tumor-infiltrating T-cells inhibits proliferation and secretion of cytokines that are important for anti-tumor T-cell-mediated activity. TIM-3 expression on CD4-positive and CD8-positive tumor-infiltrating T-cell has been associated with the generation of an immunosuppressive tumor microenvironment and PD-1 resistant. Preexisting TIM-3 expression might contribute to the relatively low response rates for anti-PD-1 antibodies observed from multiple tumor types, including unselected non-small cell lung cancer. In vitro studies demonstrate that combination treatment of human T-cells with anti-PD-1 and anti-TIM-3 antibodies can reactivate the exhausted T-cells and increase production of immune promoting cytokines.
Phase I trials of TSR-042, our anti-PD-1 antibody; and TSR-022, our anti-TIM-3 antibody, are ongoing. For TSR-042, we have identified a dose and a schedule and are now enrolling expansion cohorts. And in the coming months, we plan to initiate a registration trial for this antibody.
Our TSR-022 anti-TIM-3 antibody is in the final dose escalation cohort and by midyear, we plan to identify a dose and schedule for TSR-022 and initiate combination studies with TSR-042 shortly thereafter.
Our anti-LAG-3 clinical candidate, TSR-033 is being evaluated in IND-enabling studies, and an IND is intended for the second quarter of this year. We've also selected an anti-LAG-3 PD-1 bio-specific antibody candidate and are on target to select our first clinical candidate as part of our small molecule, IO collaboration with MD Anderson in the first half of 2017. We are very excited about the potential for our pipeline, and we look forward to keeping you apprised of our progress.
I'll now turn the call over back over to Lonnie. Lonnie?
Lonnie Moulder
Thank you, Mary Lynne. In summary, TESARO is well positioned to continue to create value for patients and shareholders, and to execute on the launch of 4 new products this year. I'll wrap up with a brief summary of our goals for a very exciting 2017.
We plan to launch VARUBI IV and niraparib in the U.S. and VARUBI oral and niraparib in Europe, we anticipate multiple data readouts, including TOPACIO data at an upcoming medical meeting and QUADRA, BRAVO and AVANOVA data in the second half of the year. We will introduce our lung cancer plans for niraparib in the first half of the year and discuss the potential registration strategy for niraparib plus TSR-042 in combination in the second half of the year.
Turning to our IO, we expect to submit the IND for TSR-033 in the second quarter of 2017 and initiate a registration program for TSR-042 in the first half.
Finally, we plan to identify a dose and schedule for TSR-022, our anti-TIM-3 antibody in mid-2017 and initiate a Phase I clinical trial in combination with an anti-PD-1 antibody shortly thereafter.
Operator, at this point could you please open up the call for questions?
Question-and-Answer Session
Operator
Thank you. [Operator Instructions] And our first question comes from Olivier Young from Crédit Suisse. Your line is now open.
Alethia Young
This is Ale Young for Olivier, thank for taking my question. So just on the SOLO-2 trial, just wanted to get your thoughts on this. If the results were similar to get us in germline BRCA, how would you look at positioning yourself in the commercial landscape?
Lonnie Moulder
Well, clearly, if the Niraparib label is expanded to include the results for SOLO-2 data that would continue to be focused just in patients who have tumors for the BRCA mutation, which from our experience with the NOVA trial and looking at the Phase II elaborate trial in a similar population, is somewhere around 30%, whereas, we anticipate the broad label for Niraparib to cover the full recurrent population of patients who are following a response would receive Niraparib response from platinum. So I think having a label and a data set that covers about 3 times the population positions us extremely well. And it's not just the data, it's actually having a label, and then not having the cumbersome aspect of a biomarker test upfront. And, although NCCN guidelines suggested these women should all receive a BRCA test for genetic counseling and personal purposes is not always the case. And even if that does occur, it requires -- when prescription is written for product, before there is adjudication, there is prior authorizations, to ensure the biomarker had been assessed and the status of that biomarker, so we'd like the position that will have a potentially with a broad label, not encumbered with some of the points I just made and obviously, a much broader population and quite powerful data as Mary Lynne reviewed.
Operator
Thank you. Our next question comes from Peter Lawson from SunTrust.
Peter Lawson
Hey Lonnie, just a follow-up on the SOLO-2 question. Due to the formulations of the passage, do you think any way you get close to Niraparib?
Mary Lynne Hedley
Yes, Peter, this is Mary Lynne. I mean, with a 50% increase in exposure I think and, again, in a BRCA2 patient population, where we expect PARP inhibitors to be most effective. There's certainly reason to believe you will see an increase in activity over Study 19. So again, I think we have to wait and to see the data and to Lonnie's point, even if the data are as good as the NOVA data, the fact that we don't have a biomarker test if we don't anticipate having a biomarker test, and the fact that we have a much broader patent population that can gain accessed to niraparib, I think that I'd rather have that doing anything.
Peter Lawson
And then just given the evolution of the lung cancer treatment landscape, how do you think about position yourself in lung cancer?
Mary Lynne Hedley
Yes, so our original thought related to lung cancer were to focus primarily on the fact that lung cancer patients were -- and other tumor types were platinum sensitive. And if you look at the HRD data, so just basically, looking at how does the genetic makeup of those patients appears using an HRD test compared to let's say, ovarian and breast cancer. We see a reasonable amount of HRD. We see platinum responsiveness. And that suggests to us the genetic background is amenable to potentially treatment with niraparib. But we knew this space is moving rapidly towards combination therapy with PD-1. So we started the TOPACIO trial, many -- eventually before we have the NOVA data in part because we were thinking, where did we need to be in a couple of years, when we have NOVA data, as we were positive having data that would speak to the niraparib PD-1 combination potential will be very helpful to solidify our thinking related to moving into these other tumor types such as lung. So I would say, we've expanded beyond our -- simply on monotherapy type of approach in terms of our thinking and moved into a combination.
Operator
Thank you. Our next question comes from Seamus Fernandez from Leerink. Your line is open.
Seamus Fernandez
So, just a couple of questions; Lonnie, can you give us a general sense of how the VARUBI launch is progressing relative to your expectations with the oral, particularly, the comment that you made on the third quarter conference call that you guys expected at least in the oral space, to be the market leader, just wondering how that's tracking? And then on the IV VARUBI opportunity, how are you guys thinking about driving that conversion? The second question is for Mary Lynne. Can you just give us a general sense for the -- have you already filed an abstract with ASCO on TOPACIO, and did you already have data at the time of the February submissions? If you can't comment on that, can you just give as a general sense of what the thresholds investors should be thinking about for the sort of potential comparators in TOPACIO so the platinum-resistant patient population response rate there, and then response rates that one perhaps might anticipate in the triple-negative patient population.
Lonnie Moulder
Seamus regarding VARUBI, the oral launch. As Tim described, we've had a really nice growth fourth quarter-over-third quarter although there was some price speculation. So as people look at the IMS data, you could just take some of the data, about 20% of out of the fourth quarter and think about what that would have meant for the first quarter. So you'll have IMS data from January this week. But we -- our December shipments put us in a number one market share position of the oral NK-1 receptor antagonist category. That category continued to shrink quite a bit up until the time we launched. So it's actually less than 10%. It's high single-digits. So the vast majority of the market opportunity is in IV. We focused on community oncology clinics that had in-office dispensing operations, and I think that's been an effective strategy. Now with IV, we'll be able to broaden our efforts with our expanded commercial organization to many more community clinics that did not have an office dispensing, about half; and the hospital segment, now that we have health systems managers in place. So the opportunity for VARUBI IV, of course is substantially greater; the IV market is about 90% of the market opportunity. So having the share penetration of one year that I just described and [technical difficulty] tells us that clinicians like the drug, the drugs delivering the benefit, and they're using as much as they can in that limited segment of the market, and that goes well for the same molecule, but in a formulation that clearly people preferred in many of the clinics because they can't dispense to enroll drug and hospitals. So that sets up us well for the IV launch. Mary Lynne?
Mary Lynne Hedley
Yes, to answer to your questions, yes, 11% to 15% and 10% to 18%. But your questions, and more specifically just probably already [indiscernible] you might not remember, yes, we do submit an abstract to ASCO, yes, we did have data although data were preliminary. And the response rate that you can expect to see or has been reported actually previously, for anti-PD-1 antibodies and with this platinum-resistant ovarian cancer 11% to 15%, and then the triple-negative breast cancer residing is 10% to 18%.
Lonnie Moulder
And of course, it is something better than that for the combination.
Operator
Thank you. Our next question comes from Adnan Butt from RBC. Your line is open.
Adnan Butt
First, sort of procedural one on niraparib. Have you actually inspected the manufacturing facilities yet or something scheduled? And then secondly, in terms of the QUADRA study, would you be able to estimate how many patients in that study would be PARP inhibitor experience?
Mary Lynne Hedley
Sure. So I mean, just to start, we don't comment on the process the FDA is going through during the NDA review. As you can imagine, we try to keep those conversations with them confidential. I would just say that, things are progressing positively, and we're happy with where we are at this point. Related to QUADRA, we would estimate, at this point that and this is still early, but let's just say 10% or so of the patients have previously seen PARP inhibitor. There is a better than underestimate and that's the whole population when you look at the BRCA immune patients, obviously with patients who had a PARP inhibitor or BRCA immune patient population so it's a drop, it's a bigger number of the BRCA immune patient population.
Operator
Our next question comes from Chris Raymond from Raymond James.
Chris Raymond
Just a couple of questions on niraparib and the process in Europe. So just noticing on, it looks like a week or 2 ago, CHMP published that you've gotten your 120-day questions. And just wanted to clarify, did you get you guys have standard assessment in Europe, if you can just confirm that, is that correct? And then also, can you maybe describe, I know, you probably don’t want talk too much about the discussions there, but maybe, maybe generally talk about their attitude towards the necessity of the HRD test. Is it more similar to FDA stands? Or more similar to how I think how you think the FDA might view that? Or is it different?
Mary Lynne Hedley
So Chris, we do receive the 120 questions and as you noted, and that we do have a standard assessment, and we don't generally comment on how conversations are going with regulators is either FDA or EMA.
Operator
Thank you. Our next question comes from Robyn Karnauskas from Citigroup. Your line is open.
Robyn Karnauskas
Thank you and you just asking a little bit about your TIM-3 and PD-1. So can you give us a little bit more color about how we learn about the registration strategy for your PD-1 and when we can get initial data? And then for TIM-3, through a combination with another checkpoint, how do you think about that as a collaboration? Or would you just be paying for drugs? And when should we get data from data for the combination?
Mary Lynne Hedley
So, Robyn, as our registration study, we actually already have started that in mind, but we are trying not to be particularly vocal about that from our competitive advantage perspective. I mean, the way you can, I guess, I can give you some guidance and I know the way to think about it. So we think about it, we think about trying to come up with a study design which looks a little bit like NOVA in the sense that identify a patient population, a sub group within the population that you think might have a strong benefit, protect that population, and in the study design but go for the greater population where you might have a broader win in a more meaningful market opportunity. I know that's not probably not particularly satisfying but and the best I can do just at this point, I think for the lot of us is to just let you know that we have a strategy in mind. We've initiated work to just get sites up and running that would be able to contribute patients to that study, and we're well on our way, related to how we think will that 042 registered.
Related to things really TIM-3, we intend to develop with 042 as I indicated, we are planning to start those combination studies in the middle of this year and the way that we think about it is with this entire on one of the data sites that we showed you during this presentation. We have extensive amount of data looking at first tumor isolate across many tumor types and with many samples within the given tumor types to phenotype those samples and understand, A do they have T cells, B, what is the phenotype of those T cells, C what is the general immuno status of those tumor samples. And one of the sizes that you saw was the expression on lung setting out PD-1 TIM-3 and likely CD8 infiltrating T cells.
So to start out if there are no T cells for a PD-1 TIM-3 approach has been useless. If the T cells are there and a substantial number of the patients have expression of TIM-3 and PD-1 on their sub surface that might be a place where you can go into that tumor type unless PD-1 antibodies is already approved, compare PD-1 to a PD-1 plus TIM-3 approach and the goal there would be to hypothesis is that, of course, you don’t have higher response rates because the patients who already have TIM-3 on as a facilitator can't respond.
So by doing a combination approach, our goal will be to increase the number of patients, the percentage of patients who can respond and then, of course, the plans since we know TIM-3 is one mechanism of PD-1 resistant potentially in with the various in that response. This updates on this phenotypic-type analysis that we're getting from our deep understanding of this going on immune profiling in many tumor samples.
Operator
Thank you. Our next question comes from Tony Butler from Guggenheim. Your line is open.
Unidentified Analyst
Hi this is Katelyn [ph] on the line for Tony. So we've heard from previous comments you made regarding the difference in patient population between the solar and PRIMA trials. I was just wondering if you could refresh us on this a bit more? And then secondly, when do you expect the updated more mature PFS2 data from NOVA? And then lastly, moving beyond lung, how are you thinking of -- you had mentioned niraparib and PD-1 in bladder and head and neck cancer settings, and now are you thinking about right now, is that something kind of in the distant future?
Mary Lynne Hedley
Sure. So Katelyn for those SOLO-1 and PRIMA trials, one of the biggest -- the big difference is that SOLO-1 is done only in the germline BRCA -- in BRCA mutant patient population, and PRIMA given the results of NOVA, we decided to expand to the entire patient population of first-line patients in response to platinum. But we're stratifying so we're riding everybody in, but we're stratifying based on HRD and then the primary analysis is on the HRD proposition again, to sort of protect the patient population is most likely to benefit. And if those patients are positively do step down analysis to include the whole patient population. So it gives you so much better opportunity than simply the germline BRCA mutant patient population in Solar1. The other difference in the study that we think could be meaningful is the fact that we're not letting patients into the study if there is no visible evidence of disease so those would be the R0 patients for the oncologists. And the reason for that is because, in previous studies, of first line ovarian trials, it's the R0 patients with patients with no visible evidence of disease that don't have even 15% of patients with the ovarian cancer are cured for the surgery and outline chemotherapy. So we want to eliminate those patients from the study, which will do two things: one, we think increase the likelihood velocity to be able to demonstrate the difference and two, we'll be able to demonstrate that difference in a reasonable period of time. It's all about getting -- enriching the patient population that's most likely to benefit, but secondly and lastly, I guess, we think the risk benefit profile is slightly different in the first line than the recurrent, so the reason I said, because some patients are, in fact, cured. So we want to focus solely on the patients that we think the risk benefit profile is most appropriate and that would be the patient who cannot be cured. So those are primary differences. And the next question is related to, I believe, the PFS2 data and to see more mature PFS2 data. You know, we'll have to see how long it takes events to progress. So there were 50% to 70% of the advance in the PFS2 were actually censored. You could see it's a relatively immature data set and that was when we blinded the NOVA trial back in end of May last year. So I imagine, some point this year or early into next year, we'll be able to provide update data on both the PFS2 and survival. And then your last question was related to moving beyond lung into potentially other tumor types such as bladder and head and neck and I would look forward to that towards the end of this year, early next year. I think I got them all.
Operator
Thank you. Our next question comes from Andrew Barron from Morgan Stanley. Your line is open.
Andrew Barron
Sounds like you've been very busy obviously and lot of time I wonder if you sleep there at all.
Lonnie Moulder
Just in deed Andrew.
Mary Lynne Hedley
Contraindicated.
Andrew Barron
Just wanted to get some color on the breast cancer patients their role in TOPACIO, and I don't know if I'm pronouncing correctly, but did they receive platinum chemo ahead of time most of them? And were there any adjuvant patients?
Mary Lynne Hedley
Well, that's a great question, actually. So we did allow patients into the study, so first of all, we only have 13 patients at the very beginning and now expanding into the 48 patients per cohort. So the data set we have is obviously smaller initially but, yes, we do a lot of patients with previous platinum, that they could not have progressed on platinum, and I guess six -- I'm getting the number wrong, within six months or something like that of receiving platinum. So we allow it, but no, they can't just blow through the platinum, to put it more clearly, I guess. Related to whether we allow adjuvant patients and we do, so patients can have received up to two prior lines of therapy.
Andrew Barron
So there could be some adjuvant patients in there, but there also could be some patients that did not have platinum-based chemo ahead of us?
Mary Lynne Hedley
Correct.
Andrew Barron
Now that you're expanding it, are you going to limit that expansion to triple-negative patients? Or are you going to have patients that could be HER2-negative, but not triple negative?
Mary Lynne Hedley
It's just triple negative at this point. We're going to maintain some level of homogeneity in the patient population, get back data and [technical difficulty] they inform us how to expand beyond triple negative.
Andrew Barron
And just wanted to ask a follow-up question on the NOVA PFS question. Are the scans still ongoing for the patients in NOVA for progression?
Mary Lynne Hedley
No. So we don't do any additional PFS analysis, but the PFS2 analysis, that Katelyn asked about that's analysis that comes after progression on NOVA, so after PFS and then they get another round of chemotherapy whatever they're going to get and then we collect the data. So those data we can continue to collect.
Andrew Barron
So the 21.5 median number is going to be the final number in that trial, there'll be no updates?
Mary Lynne Hedley
Correct.
Operator
Thank you. Our next question comes from Jim Birchenough from Wells Fargo. Your line is open.
James Birchenough
So a couple on expected labeling for niraparib. What it reopen the possibility for repeat maintenance use? And either way, are you planning to study and is QUADRA sufficient to answer that question in patients who have received prior parts. And then just on the IO side, wondering if you can give us any sense of where the expansion cohorts are occurring, are they in patients, who've failed PD-1 or in populations that typically don't respond to PD-1? And then a final question, just on the bispecific approach. I didn't hear about the PD-1 TIM-3 bispecific but is that in the works as well?
Mary Lynne Hedley
So, Jim, related to the label specific indication wording, we're obviously not in a position to discuss at this point. And more to your real question, is QUADRA really the right price to assess parts after parts? It's one place. I mean another place that we are interested in better understanding and, in particular, in the maintenance side, how do you move from one maintenance. So chemo part, chemo part, chemo part, is that really doable. And so the concept would be to take the patients coming out of first line study -- first line maintenance study like PRIMA, and have them rolling to once they progress, roll into more than observational-like study to get that and provide niraparib to them to get that additional data. And then your last question, I believe is related to the PD-1 extension cohorts and now we are enrolling on PD-1 naïve as well as PD-1 experience patients. And actually, in the case of our 042 trials, those are PD-1 naive patients in extension cohorts in the case of our 022, 042 trials. We're actually thinking of enrolling both and the reason as you've acutely not set but are implying is that there are really 2 hypotheses to test and the first one is the one that I mentioned, which is the fact that if you have an inherent resistance because you expressed PD-1 anti-TIM-3 on the surface of infiltrating T cells, then providing that TIM-3 PD-1 combo upfront, is what we're trying to do to increase the response rate and duration. But we do know that patients generate resistance and one of the mechanisms as TIM-3, so can you take a PD-1 patient, who is progressed and there are a lot of lung and normal patients, in particular, who've progressed. And give them a PD-1 TIM-3 or just a TIM-3 and see what happens. We know in vitro, that a TIM-3 antibody can trump PD-1 meaning that we can just provide a TIM-3 antibody, and we can reactivate those cells. You don't need the PD-1. A question would be if that's true in the clinic and we don't know that yet. But will be able to with those extension cohorts to test both of those hypothesis. And your last question PD-1 lactate and those with PD-1 TIM-3, right now, we only had a PD-1 like to say biospecific.
James William Birchenough
Okay. Any reason for that, Mary Lynne?
Mary Lynne Hedley
This is technically we are not able to generate a PD-1 TIM-3 biospecific. It's not due to lack of interest that we weren't able to see all of our stating efforts to come up with one.
Operator
Thank you. And we will take our last question from Boris Peaker from Cowen. Your line is open.
Boris Peaker
I just had a question on subsequent therapy from the NOVA study, specifically if you look at the time to start-up subsequent therapy in the NOVA study in the BRCA positive patients. It was 21 months, which is the same as the PFS in the niraparib patients, which patients suggested that patients were started on subsequent therapy immediately after niraparib progression. However, if we look at the placebo patients, the medium PFS was 5.5 months while the time to subsequent therapy was 8.4. So there is about a 3 months gap from progression to start-up subsequent therapy. So can you first can you first confirm that we're interpreting the data correctly? And if so, why is there gap in placebo patients, while no gap in the niraparib patients?
Mary Lynne Hedley
Yes, we can't interpret it hesitate as shown in the chart. It's very difficult to rely on the medians because a few patients one way or another have really an impact. So we're trying to focus more on the overall picture and look at the hazard ratio, but even that as I said, there is immature at this point. So I think we just have to wait for some additional data. But there was no difference in terms of just operationally, starting patients up from niraparib to their next therapy versus starting patients from placebo to their next therapy. That was all the same from internal conductance perspective.
Boris Peaker
Thanks for clarifying that. And when we would get an updated result of this? Would it be publication or you think just would be a presentation at major medical meeting?
Mary Lynne Hedley
I suspect we would do both.
Boris Peaker
Got you. And the timing for that?
Mary Lynne Hedley
As I mentioned earlier, I think, that was towards the end of this year into next year. It's not, it's something that we'd like to do based on achieving a number of events. And then in particular, with the survival analysis because we don't want, every time we do the analysis, we find ourselves to rather wait longer in patient, but we rather wait longer for the purpose of preserving the data, the integrity of the data. So at this point, we still don't have a very large number of events, not many more than we had in a year ago, almost a year ago. So I guess, that’s a good sign, but.
Boris Peaker
You could provide an update maybe in HRD-negative, which I would imagine probably on lot more events since they progressed a lot faster? Or are you waiting for the entire population to progress?
Mary Lynne Hedley
At this time we have to make that specific decision, but we still don’t have enough events in either.
Operator
Thank you. And that does conclude our question-and-answer session. I would now like to turn the conference over Lonnie Moulder for any closing remarks.
Lonnie Moulder
Thank you, everyone. We appreciate your interest, and have a good evening.
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TESARO Receives Complete Response Letter for Rolapitant IV from U.S. FDA
No concerns raised by FDA related to the rolapitant IV efficacy or safety profile and additional clinical studies are not required
Investor conference call and webcast scheduled for tomorrow at 8:30AM ET
WALTHAM, Mass., Jan. 11, 2017 (GLOBE NEWSWIRE) -- TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the rolapitant IV New Drug Application (NDA) for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy.
FDA requested additional information regarding the in vitro method utilized to demonstrate comparability of drug product produced at the two proposed commercial manufacturers for rolapitant IV that were included in the NDA. TESARO is working expeditiously to provide the requested information.
The CRL did not identify concerns related to the safety or efficacy of rolapitant IV or request additional clinical studies. No concerns were raised regarding the active pharmaceutical ingredient (API), which is also used for the VARUBI® (rolapitant) oral product.
TESARO identified potential deficiencies at the original contract manufacturer for rolapitant IV drug product, secured a second drug product supplier and included data from this manufacturer in the NDA. During the NDA review, FDA requested and TESARO provided in vitro data to demonstrate comparability of drug product made at the two manufacturing sites.
"Chemotherapy-induced nausea and vomiting (CINV) remains a significant unmet need, with more than half of patients treated with emetogenic chemotherapy experiencing this debilitating side effect," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "TESARO is committed to bringing this new intravenous formulation of rolapitant to physicians and patients to enable additional flexibility and choice of antiemetic regimens, and we plan to address FDA's questions expeditiously and complete this application, which we expect to enable approval in the first half of 2017."
Investor Conference Call and Webcast
TESARO will host a conference call to discuss this announcement tomorrow, January 12, at 8:30 A.M. Eastern time. The live webcast of the conference call can be accessed by visiting the TESARO website at www.tesarobio.com. The call can be accessed by dialing (877) 853-5334 (U.S. and Canada) or (970) 315-0307 (international). A replay of the webcast will be archived on the Company's website for 30 days following the call.
About VARUBI® (rolapitant)
VARUBI is a substance P/neurokinin-1 (NK-1) receptor antagonist indicated in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. NK-1 receptors are highly concentrated in the brain and bind neurokinin substance P. Activation of NK-1 receptors plays a central role in nausea and vomiting induced by emetogenic stimuli, including certain cancer chemotherapies. A Positron Emission Tomography (PET) study with rolapitant in normal, healthy volunteers demonstrated that rolapitant crosses the blood brain barrier and occupies brain NK-1 receptors at high levels for up to 120 hours. VARUBI has a half-life of approximately seven days, which may contribute to the ability of a single dose of VARUBI to cover the entire delayed CINV Phase (25-120 hours). VARUBI is contraindicated in patients receiving thioridazine, a CYP2D6 substrate. The inhibitory effect of a single dose of VARUBI on CYP2D6 lasts at least seven days and may last longer. Avoid use of pimozide; monitor for adverse events if concomitant use with other CYP2D6 substrates with a narrow therapeutic index cannot be avoided. Please see full prescribing information, including additional important safety information, available at www.varubirx.com.
TESARO licensed exclusive rights for the development, manufacture, commercialization and distribution of VARUBI (rolapitant) from OPKO Health, Inc.
About TESARO
TESARO is an oncology-focused biopharmaceutical company devoted to providing transformative therapies to people bravely facing cancer. For more information, visit www.tesarobio.com.
Forward Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding TESARO, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. Examples of forward-looking statements contained in this press release include, among others, statements regarding TESARO's plans to meet with FDA, provide the data requested in the complete response letter, bring the IV formulation of rolapitant to physicians and patients, and our expectation that our response to the complete response letter will enable approval of rolapitant IV in the first half of 2017 without additional clinical studies. Forward-looking statements in this release involve substantial risks and uncertainties that could cause our future results, performance, or achievements, including the potential approval and launch of the IV formulation of rolapitant, to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in drug development and the execution and completion of clinical trials, uncertainties surrounding our ongoing discussions with and potential actions by the FDA, uncertainties regarding the ultimate regulatory approval of the IV formulation of rolapitant, risks related to manufacturing and supply of the IV formulation of rolapitant, and other matters that could affect the ultimate approval, availability or commercial potential of the IV formulation of rolapitant. TESARO undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see TESARO's Annual Report on Form 10-K for the year ended December 31, 2015, and Quarterly Report on Form 10-Q for the quarter ended September 30, 2016.
Investor/Media Contact:
Jennifer Davis
Sr. Director, Corporate Development & Investor Relations
+1.781.325.1116 or jdavis@tesarobio.com
Read more: http://opkodd.proboards.com/thread/2711/tesaro-receives-complete-response-letter#ixzz4VXMj2xXp
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Q3 datas:
TESARO ANNOUNCES THIRD-QUARTER 2016 OPERATING RESULTS
Niraparib rolling NDA submission to FDA complete, MAA accepted for review by EMA
Pre-launch planning ongoing to support four potential product launches in 2017 across U.S. and Europe
Positive Phase 3 NOVA trial results presented during Presidential Symposium at ESMO 2016 and simultaneously published in New England Journal of Medicine
Cash and cash equivalents totaled approximately $647 million as of September 30, 2016
WALTHAM, Mass., Nov. 03, 2016 (GLOBE NEWSWIRE) -- TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today reported operating results for third-quarter 2016 and provided an update on the Company's marketed product and development programs.
"We are very pleased to have submitted regulatory applications for niraparib in both the United States and in Europe for the maintenance treatment of patients with platinum-sensitive, recurrent ovarian cancer who are in response to platinum-based chemotherapy. Pre-launch activities are well underway in support of four potential product launches in 2017, including VARUBI® IV and niraparib in the U.S and VARUBI oral and niraparib in Europe," said Lonnie Moulder, CEO of TESARO. "The recent ESMO 2016 Congress was very gratifying for TESARO, highlighted by the presentation of the landmark niraparib NOVA trial results during a Presidential Symposium by Dr. Mansoor Raza Mirza. We look forward to advancing our comprehensive ovarian cancer clinical program and expanding niraparib development into other tumor types in 2017."
Recent Business Highlights
The U.S. launch of VARUBI continues, and unit volume increased by 14% for the third quarter compared to the second quarter. For the month of September, VARUBI achieved a 28% market share in the oral NK-1 market in the U.S.
TESARO officially opened its international commercial headquarters in Zug, Switzerland on October 11.
Earlier this week, the rolling submission of a New Drug Application (NDA) for niraparib to the U.S. Food and Drug Administration (FDA) was completed for the maintenance treatment of patients with recurrent, platinum-sensitive ovarian cancer who are in response to platinum-based chemotherapy. The indication proposed in the niraparib NDA provides for the use of niraparib regardless of tumor biomarker status, and it is anticipated that the BRACAnalysis® CDx and myChoice® HRD tests would be available to physicians as complementary diagnostics.
The Marketing Authorisation Application (MAA) for niraparib has been submitted to and accepted for review by the European Medicines Agency (EMA) for the maintenance treatment of patients with recurrent, platinum-sensitive ovarian cancer who are in response to platinum-based chemotherapy.
The niraparib Phase 3 ENGOT-OV16/NOVA clinical trial results were presented at the Presidential Symposium at the ESMO 2016 Congress by Dr. Mansoor Raza Mirza, M.D., Medical Director of the Nordic Society of Gynecologic Oncology (NSGO) and principal investigator. These data were simultaneously published in the New England Journal of Medicine.
Planning is underway to support initiation of an Early Access Program (EAP) for niraparib in the United States and Europe.
Janssen initiated a Phase 2 clinical trial with niraparib in monotherapy in men with metastatic castration resistant prostate cancer (mCRPC) and recently began a Phase 1 safety and pharmacokinetics study of niraparib plus apalutamide (ARN-509).
Enrollment continues in the PRIMA trial for patients with first-line ovarian cancer, the QUADRA trial of niraparib for the treatment of patients with ovarian cancer who have received three or more prior lines of chemotherapy, and in the BRAVO trial for patients with germline BRCA-mutated, metastatic breast cancer.
Enrollment continues in the TOPACIO trial of niraparib plus KEYTRUDA® (pembrolizumab) in patients with ovarian cancer or with triple negative breast cancer and in the AVANOVA trial of niraparib plus bevacizumab in patients with ovarian cancer.
TESARO and Zai Lab (Shanghai) Co., Ltd. announced a collaboration to support the development and commercialization of niraparib for patients in China and the potential to advance two immuno-oncology programs outside of China.
The Phase 1 dose escalation study of TSR-022, an anti-TIM-3 antibody candidate, was initiated in July, and the Phase 1 trial of TSR-042, an anti-PD-1 antibody candidate, continues to enroll.
Third Quarter 2016 Financial Results
TESARO reported a net loss of $101.2 million, or ($1.98) per share, for the third quarter of 2016, compared to a net loss of $66.6 million, or ($1.66) per share, for the third quarter of 2015.
Net product revenue for the third quarter of 2016 totaled $2.8 million and included sales of VARUBI from specialty pharmacy customers to patients and from specialty distributors to providers that were made during the third quarter, as well as sales from specialty distributors to providers that occurred in the second quarter of 2016. License, collaboration and other revenue for the third quarter of 2016 totaled $0.9 million and included amortization of milestone payments and shipments of clinical materials under our license agreements with Hengrui and Janssen.
Research and development expenses increased to $60.8 million for the third quarter of 2016, compared to $40.1 million for the third quarter of 2015, driven primarily by higher costs related to the ongoing registration trials of niraparib, manufacturing costs associated with niraparib, and the initiation of clinical studies for our immuno-oncology portfolio, in addition to increased headcount.
Selling, general and administrative expenses increased to $37.7 million for the third quarter of 2016, compared to $22.8 million for the third quarter of 2015, primarily due to higher commercial headcount, including the establishment of a U.S. field sales organization in August 2015, commercial activities in support of the launch of VARUBI, costs associated with the establishment of our international headquarters, and higher professional service fees.
Operating expenses, as described above, include total non-cash, stock-based compensation expense of $12.9 million for the third quarter of 2016, compared to $8.1 million for the third quarter of 2015.
As of September 30, 2016, TESARO had approximately $647 million in cash and cash equivalents, which includes the $409 million in net proceeds from a follow-on offering of 5.3 million shares of common stock that was completed in July 2016. For the quarter ended September 30, 2016, TESARO had approximately 51.2 million shares outstanding on a weighted average basis.
In anticipation of four product launches in 2017, TESARO will continue to invest in pre-launch inventory manufacturing, development of supply chain capabilities and capacity, and expansion of European and targeted U.S. commercial operations, in addition to making milestone payments for regulatory submissions. As a result of these investments, the Company expects its cash and cash equivalents balance to decline by approximately $100 million during the fourth quarter of 2016.
Corporate Objectives
The following is a summary of TESARO's key objectives:
VARUBI® (rolapitant):
Achieve #1 market share position within the oral NK-1 receptor antagonist market by year-end 2016 in the U.S.;
Launch VARUBI IV into the U.S. market in 1H 2017, pending FDA approval;
Establish a European commercial organization; and
Launch VARUBI oral in Europe in 1H 2017, pending EMA approval.
Niraparib:
Continue commercial preparations in support of the launches of niraparib in the U.S. in 1H 2017 and Europe in 2H 2017, pending regulatory approvals;
Report QUADRA data in 2H 2017;
Report Phase 3 BRAVO data in 2H 2017;
Finalize a potential lung cancer registration strategy and initiate development program in 1H 2017; and
Determine the potential registration strategy for niraparib plus an anti-PD-1 antibody in ovarian cancer and triple-negative breast cancer in 2H 2017.
Immuno-Oncology Portfolio:
Identify a dose and schedule for TSR-042 (anti-PD-1 antibody) by the end of 2016;
Select at least one bispecific antibody clinical candidate by the end of 2016;
Identify the first clinical candidate within the MD Anderson collaboration in 1H 2017;
Initiate a Phase 1 study of TSR-033 (anti-LAG-3 antibody) in 1H 2017;
Finalize the TSR-042 registration strategy and initiate a registration program in 1H 2017; and
Initiate a Phase 1 clinical trial of TSR-022 in combination with an anti-PD-1 antibody in mid-2017.
Today's Conference Call and Webcast
TESARO will host a conference call to discuss the Company's third-quarter operating results and provide an update on the Company's development programs and the VARUBI® launch today at 4:15 P.M. Eastern time. The accompanying slide presentation and live webcast of the conference call can be accessed by visiting the TESARO website at www.tesarobio.com. The call can be accessed by dialing (877) 853-5334 (U.S. and Canada) or (970) 315-0307 (international). A replay of the webcast will be archived on the Company's website for 30 days following the call.
About TESARO
TESARO is an oncology-focused biopharmaceutical company dedicated to improving the lives of cancer patients by acquiring, developing, and commercializing safer and more effective therapeutics. For more information, visit www.tesarobio.com, and follow us on Twitter and LinkedIn.
Forward Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding TESARO, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. Examples of forward-looking statements contained in this press release include, among others, statements regarding the expected decline in our cash and cash equivalents balance during the fourth quarter of 2016, the expected timing of the launches of niraparib and VARUBI IV in the U.S., the timing of our planned commercial launches of niraparib and oral rolapitant in Europe, statements regarding the details of our various corporate objectives, and statements regarding the potential indication for niraparib and the potential complementary use of the Myriad myChoice® HRD test and BRACAnalysis CDx® in connection with niraparib. Forward-looking statements in this release involve substantial risks and uncertainties that could cause our research and pre-clinical development programs, clinical development programs, future results, performance, or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the execution and completion of clinical trials, uncertainties surrounding our ongoing discussions with and potential actions by regulatory authorities, uncertainties regarding regulatory approvals, including with respect to the ultimate approval and indication for niraparib, uncertainties regarding certain expenditures, risks related to manufacturing and supply, and other matters that could affect the availability or commercial potential of our drug candidates. TESARO undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see TESARO's Annual Report on Form 10-K for the year ended December 31, 2015, and Quarterly Report on Form 10-Q for the quarter ended June 30, 2016.
TESARO, Inc.
Unaudited Condensed Consolidated Statements of Operations
(in thousands, except per share amounts)
Three Months Ended
September 30, Nine Months Ended
September 30,
2015 2016 2015 2016
Revenues:
Product revenue, net $ - $ 2,799 $ - $ 4,408
License, collaboration and other revenues 87 931 87 36,190
Total revenues 87 3,730 87 40,598
Expenses:
Cost of sales - product - 424 - 738
Cost of sales - intangible asset amortization - 464 - 1,391
Research and development (1) 40,063 60,783 112,538 163,630
Selling, general and administrative (1) 22,766 37,685 50,791 104,052
Acquired in-process research and development - 1,940 1,000 9,940
Total expenses 62,829 101,296 164,329 279,751
Loss from operations (62,742 ) (97,566 ) (164,242 ) (239,153 )
Interest income (expense), net (3,844 ) (3,587 ) (11,407 ) (11,377 )
Net loss $ (66,586 ) $ (101,153 ) $ 175,649 ) $ (250,530 )
Net loss per share applicable to common stockholders - basic and diluted $ (1.66 ) $ (1.98 ) $ (4.49 ) $ (5.45 )
Weighted-average number of common shares used in net loss per share applicable to common stockholders - basic and diluted 40,038 51,151 39,129 45,994
(1) Expenses include the following amounts of non-cash stock-based compensation expense:
Research and development $ 3,783 $ 5,605 $ 7,808 $ 13,826
Selling, general and administrative 4,346 7,314 9,702 20,238
TESARO, Inc.
Unaudited Condensed Consolidated Balance Sheets
(in thousands)
December 31,
2015 September 30,
2016
Assets
Current assets:
Cash and cash equivalents $ 230,146 $ 647,315
Accounts receivable 679 3,214
Inventories 1,106 12,163
Other current assets 4,560 7,409
Total current assets 236,491 670,101
Intangible assets, net 14,732 13,341
Property and equipment, net 2,779 3,781
Restricted cash 500 620
Other assets 779 1,751
Total assets $ 255,281 $ 689,594
Liabilities and stockholders' equity
Current liabilities:
Accounts payable $ 8,019 $ 3,264
Accrued expenses 36,628 53,135
Deferred revenue, current 500 772
Other current liabilities 1,534 670
Total current liabilities 46,681 57,841
Convertible notes, net 121,325 129,017
Deferred revenue, non-current 288 -
Other non-current liabilities 113 515
Total liabilities 168,407 187,373
Total stockholders' equity 86,874 502,221
Total liabilities and stockholders' equity $ 255,281 $ 689,594
Contacts:
Jennifer Davis
+1.781.325.1116 or jdavis@tesarobio.com
Kate Rausch
+1.781.257.2505 or krausch@tesarobio.com
Data presentation of niraparib (NOVA) at IGCS
WALTHAM, Mass., Oct. 31, 2016 (GLOBE NEWSWIRE) -- TESARO, Inc. (TSRO), an oncology-focused biopharmaceutical company, today announced the presentation of data from the ENGOT-OV16/NOVA trial of niraparib at the 2016 International Gynecologic Cancer Society (IGCS) Biennial Meeting in Lisbon, Portugal. These data were presented on Sunday, October 30 during the Best Oral session by Dr. Ursula Matulonis, M.D., Medical Director of the Gynecologic Oncology Program at Dana-Farber Cancer Institute and principal investigator on the ENGOT-OV16/NOVA trial, during the Best Oral session. The results were previously published in the New England Journal of Medicine on October 8, 2016 and presented at the ESMO 2016 Congress.
“Many women with recurrent ovarian cancer experience a fear of recurrence in between regimens of platinum-based chemotherapy. The availability of an oral maintenance treatment that could lengthen the progression free survival interval between rounds of platinum-based chemotherapy with a tolerable side effect profile could be very empowering for patients,” said Dr. Matulonis. “The data from ENGOT-OV16/NOVA are extremely encouraging and demonstrate the potential of niraparib to offer a meaningful benefit for our patients with ovarian cancer.”
“We are grateful for the patients, their families, and the caregivers that participated in the ENGOT-OV16/NOVA study, and we would like to thank our partners at ENGOT for their diligence in executing this trial,” said Mary Lynne Hedley, Ph.D., President and COO of TESARO. “We believe the results of this Phase 3 study demonstrated a meaningful benefit for women with platinum sensitive, recurrent ovarian cancer. We are pleased that the EMA recently accepted for review the MAA for niraparib, and we are on track to complete the rolling NDA submission imminently.”
ENGOT-OV16/NOVA is a double-blind, placebo-controlled, international Phase 3 trial of niraparib that enrolled 553 patients with recurrent ovarian cancer who were in response to their most recent platinum-based chemotherapy. This trial was designed to assess progression free survival (PFS) in a broad population of patients who were assigned to one of two cohorts based upon germline BRCA mutation status. The ENGOT-OV16/NOVA trial successfully achieved its primary endpoint in both cohorts, demonstrating that niraparib treatment significantly prolonged PFS compared to control in patients who were germline BRCA mutation (gBRCAmut) carriers and in patients who were not germline BRCA mutation (non-gBRCAmut) carriers. A high proportion of patients in both treatment groups in both cohorts had received three or more prior lines of chemotherapy.
The most common (≥10%) treatment-emergent grade 3/4 adverse events in the niraparib arm were thrombocytopenia (33.8%), anemia (25.3%), and neutropenia (19.6%) with treatment discontinuation for these events of 3.3%, 1.4% and 1.9%, respectively. Thrombocytopenia was not associated with grade 3/4 bleeding events. The majority of these hematological laboratory abnormalities occurred within the first three cycles; following dose modifications the incidence of these lab abnormalities decreased and thrombocytopenia and neutropenia were infrequent beyond cycle 3. The rates of MDS/AML in the niraparib (1.4%) and control (1.1%) arms were similar. There were no deaths among patients during study treatment.
About the Phase 3 ENGOT-OV16/NOVA Clinical Trial of Niraparib
ENGOT-OV16/NOVA is a double-blind, placebo-controlled, international Phase 3 trial of niraparib that enrolled 553 patients with recurrent ovarian cancer who were in a response to their most recent platinum-based chemotherapy. Patients were enrolled into one of two independent cohorts based on germline BRCA mutation status. One cohort enrolled patients who were germline BRCA mutation carriers (gBRCAmut), and the second cohort enrolled patients who were not germline BRCA mutation carriers (non-gBRCAmut) and included patients with HRD-positive and HRD-negative tumors. Within each cohort, patients were randomized 2:1 to receive niraparib or placebo and were treated continuously with placebo or 300 milligrams of niraparib, dosed as three 100 milligram tablets once per day, until progression. The primary endpoint of this study was progression-free survival (PFS). Secondary endpoints include patient-reported outcomes, chemotherapy-free interval length, PFS 2, overall survival, and other measures of safety and tolerability. More information about this trial is available at http://clinicaltrials.gov/show/NCT01847274.
About Niraparib
Niraparib is an oral, once-daily PARP inhibitor that is currently being evaluated in four ongoing pivotal trials. TESARO is building a robust niraparib franchise by assessing activity across multiple tumor types and by evaluating several potential combinations of niraparib with other therapeutics. The ongoing development program for niraparib includes a Phase 3 trial in patients with platinum-sensitive, recurrent ovarian cancer (the NOVA trial); a Phase 3 trial in patients with first-line ovarian cancer (the PRIMA trial); a registrational Phase 2 treatment trial in patients with ovarian cancer (the QUADRA trial); and a Phase 3 trial for the treatment of patients with BRCA-mutant breast cancer (the BRAVO trial). Several combination studies are also underway, including trials of niraparib plus pembrolizumab and niraparib plus bevacizumab. Janssen Biotech has licensed rights to develop and commercialize niraparib specifically for patients with prostate cancer worldwide, except in Japan.
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to niraparib for the treatment of patients with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer. TESARO has initiated a rolling submission of a New Drug Application (NDA) for niraparib to the FDA, and intends to complete this submission during the fourth quarter. The Marketing Authorization Application (MAA) for niraparib has been submitted to and accepted for review by the European Medicines Agency (EMA) for the maintenance treatment of patients with platinum-sensitive, recurrent ovarian cancer who are in response to platinum-based chemotherapy.
Niraparib is an investigational agent and, as such, has not been approved by the U.S. FDA, the European Medicines Agency (EMA), or any other regulatory agencies.
About Ovarian Cancer
Approximately 22,000 women are diagnosed each year with ovarian cancer in the United States, and more than 65,000 women are diagnosed annually in Europe. Ovarian cancer is the fifth most frequent cause of cancer death among women. Despite high response rates to platinum-based chemotherapy in the second-line advanced treatment setting, approximately 85% of patients will experience recurrence within two years. If approved, niraparib may address the difficult “watchful waiting” periods experienced by patients with recurrent ovarian cancer in between cycles of platinum-based chemotherapy.
About TESARO
TESARO is an oncology-focused biopharmaceutical company dedicated to improving the lives of cancer patients by acquiring, developing and commercializing safer and more effective therapeutics. For more information, visit www.tesarobio.com.
To the extent that statements contained in this press release are not descriptions of historical facts regarding TESARO, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this release involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in expectations with respect to regulatory submissions and approvals, and other matters that could affect the availability or commercial potential of our drug candidates. TESARO undertakes no obligation to update or revise any forward-looking statements. TESARO undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see TESARO's Annual Report on Form 10-K for the year ended December 31, 2015, and its Quarterly Report on Form 10-Q for the quarter ended June 30, 2016.
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Forget Sarepta Therapeutics, Here Are 3 Other Biotech Stocks to Buy
Upcoming FDA decisions could lead to Portola Pharmaceuticals, Puma Biotech, and Tesaro Inc. outperforming Sarepta Therapeutics.
Todd Campbell (TMFEBCapital) Sep 20, 2016 at 3:01PM
Pills And Dollars Flickr User Chris Potter
IMAGE SOURCE: STOCKMONKEYS.COM VIA FLICKR.
When the FDA approved Sarepta Therapeutics' (NASDAQ:SRPT) controversial Duchenne muscular dystrophy drug, Exondys 51, it caused shares in the company to surge 74% -- a market cap of $2.4 billion may fairly value it now. If so, then investors considering new positions in Sarepta Therapeutics might want to look at other ideas, including these three clinical-stage biotech stocks.
No. 1: Overcoming headwinds
Setbacks at Portola Pharmaceuticals (NASDAQ:PTLA) this year have caused its shares to sink about 50% from their peak above $50 last year, but headwinds could shift to tailwinds soon, and if they do, shares could be about to head higher.
This past spring, Portola Pharmaceuticals reported mixed results for its factor Xa anticoagulant, betrixaban, which was being studied head-to-head against Lovenox for use in acutely ill patients who have recently been discharged from hospitals.
Unfortunately, a complex trial design resulted in three cohorts of patients in which results were to be viewed sequentially, and betrixaban missed the market in the first cohort. Although it missed its mark in this subset of patients, it was effective in both cohort 2 and cohort 3, and across the entire study, there was a 24% relative risk reduction for patients on betrixaban versus Lovenox, with a p-value of 0.006.
There's no telling how the FDA will view these mixed results during a review, but Portola Pharmaceuticals still plans to file for betrixaban's approval soon, so there could be additional clarity on the subject next year.
Portola Pharmaceuticals' second setback came in August, when the FDA delayed an approval decision on AndexXa, a reversal agent for the multibillion-dollar factor Xa anticoagulants Xarelto and Eliquis. AndexXa's efficacy and safety in trials appears solid, but FDA questions regarding AndexXa's manufacturing and the use of it to reverse other factor Xa drugs prompted the rejection.
In both instances, Portola Pharmaceuticals' stumbles appear to me to be more an indictment of management's failure to execute than a failure of these drugs, both of which have 9-figure-plus potential. If I'm correct, both of these drugs could net FDA decisions in 2017 that could cause share prices to spike.
No. 2: Improving outcomes
At Cougar Biotech, Alan Auerbach developed Zytiga, a multibillion-dollar prostate cancer drug that he sold to Johnson & Johnson for $1 billion in 2009. Today, Auerbach is trying to capture lightening in a bottle a second time with neratinib, a breast cancer therapy he's working on at his new company, Puma Biotechnology (NYSE:PBYI)
Puma Biotechnology submitted an application for neratinib's approval earlier this year, and that application was accepted by the regulator for review earlier today. If approved, neratinib could become a staple used for the extended adjuvant treatment of patients with early-stage HER2+ breast cancer who have been previously treated with Herceptin to delay the recurrence of their cancer.
In trials, neratinib patients saw a 33% reduction of risk of invasive disease recurrence or death versus placebo, and the two-year invasive disease-free survival rate for neratinib patients was 93.9% compared to 91.6% for placebo patients.
While every advantage is welcome in this important indication, there's no guarantee the FDA will approve neratinib, because there are some concerns over the percentage risk of severe diarrhea. The disclosure of the diarrhea risk caused a significant sell-off in Puma Biotechnology shares in 2015; however, studies are ongoing that include the use of anti-diarrhea medicine that could manage that risk.
Although 39.9% of patients reported grade 3 or higher diarrhea while receiving neratinib in phase 3 studies, interim results from a phase 2 study show that using the anti-diarrhea drug loperamide reduced the rate of grade 3 or higher diarrhea in neratinib patients to between 13% and 18.5%.
If the FDA determines that anti-diarrhea prophylaxis overcomes any objections regarding this drug's safety, then Puma Biotechnology could have a blockbuster drug on its hands. In addition to the potential use in the adjuvant setting, neratinib is also being evaluated for earlier use in breast cancer. If those trials pan out, Puma Biotechnology could be an attractive pure-play cancer stock that a suitor may want to cozy up to.
No. 3. Big decisions on deck
Tesaro Inc. (NASDAQ:TSRO) recently reported compelling results from a registration-ready study of niraparib, a PARP inhibitor being studied as a treatment to delay disease progression in ovarian cancer in previously treated patients.
In trials, niraparib statistically and significantly outperformed the control arm of the study, delivering progression-free survival of 21 months in patients with germline BRCA mutations versus 5.5 months for the control arm. PFS was 9.3 months in non-germline BRCA patients, which was also significantly better than the 3.9 months for the control arm.
Tesaro expects to complete a rolling filing for FDA approval in Q4 and if so, then a quick review by the FDA could get this drug on the market in the first half of 2017. Additional trials that could expand niraparib's use to earlier in ovarian cancer treatment are ongoing.
At the onset, Tesaro estimates niraparib's addressable patient population is 10,000 people in the U.S. and while management hasn't said what it will charge for the drug, a competing PARP-inhibitor, Lynparza, costs $13,000 per month and generated almost $100 million in sales during the first six months of 2016.
In January, Tesaro also expects a FDA decision on an IV formulation of Varubi, its chemotherapy induced nausea and vomiting (CINV) drug. An oral formulation of Varubi is already on the market, and it's quickly becoming the most widely used oral drug in the NK-1 class of CINV medicines. An approval of the IV formulation would significantly increase Varubi's addressable market because oral NK-1 drugs only represent about 20% of the NK-1 market. Although it's anyone's guess what peak sales could be for Varubi, the NK-1 drug Emend generates more than a half billion dollars in sales annually, so that could be a good proxy.
Tying it together
Sarepta Therapeutics' approval of Exondys 51 is undeniably a win, but it will be a while before investors get clarity into the drug's commercial progress, and that could keep a lid on the company's share price. In that case, investors considering a new position in Sarepta Therapeutics may find upcoming FDA catalysts for Portola Pharmaceuticals, Puma Biotechnology, and Tesaro Inc. make them more attractive.
Looking Ahead To The Potentially Game Changing TESARO Data http://marketexclusive.com/looking-ahead-potentially-game-changing-tesaro-inc-nasdaqtsro-data/32340/?icd1
Tesaro, Inc. TSRO announced that the FDA has granted Fast Track designation to its pipeline candidate, niraparib, for the treatment of patients with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer.
Tesaro has initiated a rolling submission of a New Drug Application (NDA) for niraparib to the FDA. The company plans to complete the submission during the fourth quarter of 2016.
The FDA’s Fast Track designation facilitates the development and expedites the review of drugs that are intended to treat serious conditions and address unmet medical needs.
As part of the Fast Track program, the FDA allows for the submission of completed portions of an NDA on an ongoing or rolling basis. Tesaro is also planning to submit a Marketing Authorisation Application (MAA) for niraparib with the European Medicines Agency (EMA) in the fourth quarter.
We note that Tesaro is currently evaluating niraparib in four ongoing trials – a phase III trial, NOVA, in patients with platinum-sensitive, recurrent ovarian cancer; a phase III trial, PRIMA, in patients with first-line ovarian cancer; a registrational phase II trial, QUADRA, in patients with ovarian cancer; and a phase III trial, BRAVO, in patients with BRCA-positive breast cancer.
The company plans to present data from NOVA at a medical summit next month. The trial enrolled more than 500 patients with recurrent ovarian cancer, who were in response to their most recent platinum-based chemotherapy.
We note that the FDA approved Tesaro’s first commercial product, Varubi, for use in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy in Sep 2015.
Tesaro currently carries a Zacks Rank #3 (Hold). Investors interested in the healthcare sector may consider stocks like ArQule Inc. ARQL, Pacira Pharmaceuticals PCRX and ANI Pharmaceuticals ANIP. While Pacira and ANI Pharma sport a Zacks Rank #1 (Strong Buy), ArQule is a Zacks Rank #2 (Buy) stock.
5 very interesting posts...
TESARO (NASDAQ:TSRO) initiated with Outperform rating and $122 (28% upside) price target by RBC Capital.
Tesaro Q2 results on August 4, 2016
WALTHAM, Mass., July 21, 2016 (GLOBE NEWSWIRE) -- TESARO, Inc. (TSRO) will announce its second-quarter 2016 financial results on Thursday, August 4, 2016, after the close of the U.S. financial markets. TESARO’s senior management will host a conference call and live audio webcast at 4:15 p.m. ET on August 4, 2016 to discuss the Company’s operating results in greater detail, as well as the status of its development programs and the VARUBI® launch.
The quarterly earnings call will be available via phone and webcast. The conference call dial-in information is listed below. To access the webcast, please log on to the TESARO website at www.tesarobio.com at least 15 minutes prior to the start of the call to ensure adequate time for any software downloads that may be required.
******************CONFERENCE CALL & WEBCAST INFORMATION******************
TESARO will host a conference call and live audio webcast to discuss its second-quarter financial results.
WHEN: Thursday, August 4, 2016 at 4:15 p.m. ET
LIVE DOMESTIC & CANADA CALL-IN: (877) 853-5334
LIVE INTERNATIONAL CALL-IN: (970) 315-0307
THIS CALL WILL ALSO BE BROADCAST LIVE, LISTEN ONLY, VIA THE WEB AT: www.tesarobio.com
A replay will be available for 30 days at www.tesarobio.com.
**********************************************************************************
About TESARO
TESARO is an oncology-focused biopharmaceutical company devoted to providing transformative therapies to people bravely facing cancer. For more information, visit www.tesarobio.com
ENGOT and TESARO Partnership Generates Positive Data
The ENGOT-OV16/NOVA trial successfully achieved its primary endpoint of PFS in the germline BRCA mutant cohort
The ENGOT-OV16/NOVA trial successfully achieved its primary endpoint of PFS in the non-germline BRCA mutant cohort, including both the HRD-positive and overall analysis populations
ENGOT-OV16/NOVA is the first successful prospectively designed Phase 3 trial of a PARP inhibitor
NDA and MAA submissions are planned for Q4 2016
BERLIN, July 08, 2016 (GLOBE NEWSWIRE) -- ENGOT (European Network of Gynaecological Oncology Trial Groups), today announced that the Phase 3 ENGOT-OV16/NOVA trial of niraparib successfully achieved its primary endpoint of progression-free survival (PFS). This trial is led by NSGO (Nordic Society of Gynaecological Oncology) in partnership with TESARO, Inc. and is the first successful Phase 3 trial of a PARP inhibitor to be completed in ovarian cancer. More than 500 patients with recurrent disease who were in response to their most recent platinum-based chemotherapy regimen enrolled in the trial.
As previously reported, this trial demonstrated that niraparib significantly prolonged PFS compared to control among patients who are germline BRCA mutation (gBRCAmut) carriers, among patients who are not germline BRCA mutation (non-gBRCAmut) carriers but who have homologous recombination deficient (HRD) tumors as determined by the Myriad myChoice®HRD test, and overall in patients who are not germline BRCA mutation carriers.
“The data suggest that niraparib, if approved, will be a step forward in the management of our patients and a potential new treatment option for ovarian cancer patients,” said Mansoor Raza Mirza, M.D., Study Chair and Medical Director of NSGO.
“ENGOT with their collaborative clinical trial groups has put a lot of effort to bring this trial to success and this is a great example how today international collaboration between academic groups and industry can benefit patients,” said Christian Marth, President of ENGOT.
“We are extremely grateful to the patients, caregivers, and investigators, including our partners at ENGOT, who participated in this trial. The results of this study demonstrate that a single, daily, oral dose of niraparib is superior to control in prolonging PFS in women with recurrent ovarian cancer,” said Mary Lynne Hedley, Ph.D., President and COO of TESARO. “In keeping with our mission of responsible drug development, ENGOT-OV16/NOVA was designed to define those patients most likely to benefit from niraparib treatment and, in so doing, optimize the benefit/risk profile for patients. We believe we have achieved that goal and look forward to our presentation of the full data set from this study at the European Society for Medical Oncology (ESMO) congress in October.”
About the Phase 3 ENGOT-OV16/NOVA Clinical Trial
NOVA is a double-blind, placebo-controlled, international Phase 3 trial of niraparib that planned to enroll 490 patients with recurrent ovarian cancer who were in a response to their most recent platinum-based chemotherapy. Patients were enrolled into one of two independent cohorts based on germline BRCA mutation status. One cohort enrolled patients who were germline BRCA mutation carriers (gBRCAmut), and the second cohort enrolled patients who were not germline BRCA mutation carriers (non-gBRCAmut). The non-gBRCAmut cohort included patients with HRD-positive tumors, including those with somatic BRCA mutations and other HR defects, and patients with HRD-negative tumors. Within each cohort, patients were randomized 2:1 to receive niraparib or placebo and were treated continuously with placebo or 300 milligrams of niraparib, dosed as three 100 milligram tablets once per day, until progression. The primary endpoint of this study was progression-free survival (PFS). Secondary endpoints include patient-reported outcomes, chemotherapy-free interval length, PFS2, overall survival, and other measures of safety and tolerability.
The most common (≥10%) treatment-emergent grade 3/4 adverse events among all patients treated with niraparib were thrombocytopenia (28.3%), anemia (24.8%) and neutropenia (11.2%). Adverse events were generally managed via dose modifications. The discontinuation rate was 14.7% for niraparib treated patients and 2.2% for control.
More information about this trial is available at clinicaltrials.gov/show/NCT01847274.
Niraparib is an investigational agent and, as such, has not been approved by the U.S. FDA or any other regulatory agencies.
About Niraparib
Niraparib is an oral, once-daily PARP inhibitor that is currently being evaluated in three ongoing pivotal trials. TESARO is building a robust niraparib franchise by assessing activity across multiple tumor types and by evaluating several potential combinations of niraparib with other therapeutics. The ongoing development program for niraparib includes the Phase 3 trial in patients with ovarian cancer (the NOVA trial) as described above; a registrational Phase 2 treatment trial in patients with ovarian cancer (the QUADRA trial); a Phase 3 trial for the treatment of patients with BRCA-positive breast cancer (the BRAVO trial); and a Phase 3 trial in patients with first-line ovarian cancer (the PRIMA trial). Several collaborator-sponsored studies are also underway, including combination trials of niraparib plus pembrolizumab and bevacizumab. Janssen Biotech has licensed rights to develop and commercialize niraparib specifically for patients with prostate cancer worldwide, except in Japan
About ENGOT
The European Network for Gynaecological Oncological Trial groups (ENGOT) is a research network of the European Society of Gynaecological Oncology (ESGO) and was founded in Berlin in October 2007. Currently, ENGOT consists of 19 trial groups from 15 European countries that perform cooperative clinical trials. ENGOT's ultimate goal is to bring the best treatment to gynecological cancer patients through the best science, and enabling every patient in every European country to access a clinical trial.
About NSGO
Nordic Society of Gynaecological Oncology (NSGO) is a non-political, non-profit society dedicated to initiate, promote and conduct collaborative clinical trials in gynaecological cancers. NSGO in the past 30 years has successfully contributed to bring novel cancer agents to registration. NSGO is one of the leading collaborative groups within ENGOT as well as within Gynecologic Cancer InterGroup (GCIG).
About TESARO
TESARO is an oncology-focused biopharmaceutical company devoted to providing transformative therapies to people bravely facing cancer. For more information, visit www.tesarobio.com, and follow us on Twitter and LinkedIn.
TESARO Forward Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding TESARO, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. Examples of forward-looking statements contained in this press release include, among others, statements regarding our expectation to submit the NDA and MAA for niraparib in the fourth quarter of 2016 and to present the full NOVA data set at an upcoming medical meeting. Forward-looking statements in this release involve substantial risks and uncertainties that could cause our research and pre-clinical development programs, clinical development programs, future results, performance, or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, competition from other pharmaceutical companies, the uncertainties inherent in the execution and completion of clinical trials, uncertainties surrounding the timing of availability of data from our clinical trials, ongoing discussions with and actions by regulatory authorities, patient accrual and event rates for clinical trials, and other matters that could affect the timing of availability of data from or initiation of our clinical trials, uncertainties regarding regulatory approvals, risks related to manufacturing and supply, uncertainties regarding certain expenditures, and other matters that could affect the availability or commercial potential of our drug candidates. TESARO undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see TESARO's Annual Report on Form 10-K for the year ended December 31, 2015, and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2016.
Read more: http://opkodd.proboards.com/thread/1495/engot-tesaro-partnership-generates-positive#ixzz4DqqD63GO
A Big Breakthrough for Ovarian Cancer Patients
Tesaro's PARP-inhibitor niraparib just delivered remarkable results when used in previously treated ovarian cancer patients.
Todd Campbell (TMFEBCapital) Jul 3, 2016 at 7:40AM
Senior Woman Happy Gettyimages
IMAGE SOURCE: GETTY IMAGES.
A savvy decision by Tesaro (NASDAQ:TSRO) to buy the rights to a novel anti-tumor drug from Merck & Co. (NYSE:MRK) for $7 million up front in 2012 has just paid off big for patients and Tesaro investors.
This past week, Tesaro reported results from a large late-stage study showing that niraparib effectively delays the progression of ovarian cancer in patients previously treated with platinum-based therapies. Those results are important, because up to 85% of ovarian cancer patients see their cancer return, and despite advances in care, ovarian cancer remains the second most deadly cancer facing women.
A big bargain delivers a big breakthrough
Tesaro handed Merck & Co. $7 million in cash to secure the rights to niraparib and a second tumor-fighting compound, MK-2515, back in 2012. At the time, niraparib was in the infancy of early stage studies, and Merck was eager to shrink its R&D footprint ahead of revenue-depleting patent expirations.
Based on niraparib's phase 3 trial results, niraparib's low upfront cost appears to have been a bargain.
Niraparib, which is taken once daily, has now been shown to delay the return of ovarian cancer. It does that by inhibiting the activity of PARP, which are proteins that are responsible for quickly repairing damage to DNA. While PARP activity is a good thing in healthy patients, it can be a bad thing for cancer patients because it reduces the damage that chemotherapy does to cancer DNA.
In trials, patients who were identified as carriers of the germline BRCA mutation and were given niraparib had a median 21 months of progression-free survival. That was miles better than the median 5.5 months for patients who weren't given niraparib.
Niraparib also delayed disease progression in patients who weren't carriers of the BRCA mutation, but who were positive for homologous recombination deficiency (HRD). Progression-free survival for HRD patients was 12.9 months, versus 3.8 months for patients not given niraparib.
Additionally, patients who were negative for germline BRCA mutation and negative for HRD had a median progression free survival of 9.3 months, which also bested the 3.9 months achieved in the control arm of the study.
Looking forward
Tesaro is the first drug developer working on a PARP inhibitor to prove the approach effective in late-stage trials involving this patient population. That first-mover advantage could prove to be significant, assuming that the company can make good on its timeline to file niraparib for FDA approval by the end of this year.
The FDA will need to review all of niraparib's trial data, including data related to its safety, before approving it. However, the safety data doesn't seem to raise too many eyebrows. There were no deaths among patients during the study period, and most adverse events niraparib patients suffered were manageable by adjusting the patients' dosage of the drug.
Assuming the FDA agrees that niraparib's results warrant an approval, this drug could quickly become a standard that's used in a lot of ovarian cancer patients who are in remission thanks to previous treatment. Overall, about 200,000 people are diagnosed with ovarian cancer, and another 22,000 new cases are diagnosed every year the United States. Therefore, niraparib could prove to be an important win for patients and Tesaro's shareholders.
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Read more: http://opkodd.proboards.com/thread/1457/tsro-breakthrough-ovarian-cancer-patients#ixzz4DN5okSGZ
Why would there be a squeeze if they're diluting?? Where's the logic in that??
What a squeeze coming! All the remaining shorts who averaged up their attacks are now forced to cover. Big days coming congrats longs!
TESARO Announces Proposed Public Offering of Common Stock
Source: GlobeNewswire Inc.
TESARO, Inc. (NASDAQ:TSRO) announced today that it has commenced an underwritten public offering of $300 million of its common stock. In connection with this offering, TESARO plans to grant the underwriters an option to purchase up to an additional $45 million of its common stock. Citigroup, Leerink Partners, Credit Suisse and Wells Fargo Securities are acting as bookrunners, and Mizuho, Raymond James, SunTrust Robinson Humphrey and Wedbush PacGrow are acting as co-managers for the offering. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.
The offering will be made by TESARO pursuant to its automatic shelf registration statement on Form S-3 filed with the Securities and Exchange Commission (SEC) on June 30, 2016. A preliminary prospectus supplement and related prospectus related to the offering have been filed with the SEC and are available on the SEC’s website located at http://www.sec.gov. Copies of the preliminary prospectus supplement and related prospectus relating to this offering may be obtained from Citigroup, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, via telephone at 1-800-831-9146 or from Leerink Partners LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA, 02110, via telephone at 1-800-808-7525 (ext. 6142) or email at syndicate@leerink.com.
This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor will there be any sale of, these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state or other jurisdiction.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which involve risks and uncertainties, including statements regarding the proposed public offering. Various factors may cause differences between TESARO's expectations and actual results, including risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions related to the proposed offering. More information about potential factors that could affect TESARO’s business and financial results is contained in its annual report on Form 10-K, its quarterly reports on Form 10-Q and other filings with the SEC. TESARO does not intend, and undertakes no duty, to update this information to reflect future events or circumstances.
About TESARO
TESARO is an oncology-focused biopharmaceutical company devoted to providing transformative therapies to people bravely facing cancer.
Investor/Media Contact
Jennifer Davis
Sr. Director, Corporate Development & Investor Relations
+1.781.325.1116 or jdavis@tesarobio.com
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Point72 Accumulating TSRO https://fintel.io/soh/us/tsro/point72-asset-management
Approximately 40% of the outstanding shares were traded today.
The shorts will be burn...
I think so too, got some Aug 19 '16 $55 Puts, already up around 15%
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