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So tonight we will hear about acceptance of BLA for Rolontis cause 60 days are over?
And maybe they release bad news regarding the poziotinib trial ZENITH20 -cohort1? At least that is what the price action wants to say. If they are sitting on bad news they will be pressured to release now cause of the negative price action... there may be a leak.
Just pure speculation.
Always remember: this is SPPI, this Co. cannot be trusted. JMHO.
This is really nuts.
Are they sitting on bad news for Zenith20 cohort 1 or why is there no release? It is 12-19 now!!!
Lets me think that they are waiting for acceptance of rolontis BLA to give the market a small piece of good news to cover a part of big bad news.
Saw it too often... and this is SPPI. So i would be not suprised if it goes like that...
Just wondering...
Bullshit buyout rumor:
BREAKING: A Deal Is In The Works_Spectrum Pharmaceuticals $SPPI Board Of Directors To Vote On Seattle Genetics $SGEN Offer Early Next Week
https://rumormurmursbuzz.blogspot.com/2018/12/a-deal-is-in-worksspectrum.html
Source: Twitter
Ville is at 80%
A little doubt remains:
Normally the FDA wants at least 6 months PFS to give BTD to a drug. We only have 5.5 months.
But with the comparator 1.9 months this reqirement could be meaningless.
We will see by year end.
Combination with Kadcyla will be telling. I hope they make a deal with Roche to only pay the half of the costs of necessary trials.
Frankly i don't know. But it is not good, because patients don't find their options.
I don't like the thinking that they maybe want to slow down US recruitment to wait for the EU sites to open.
I signed out at WO; i stated it there what the reasons were. I don't plan to come back.
Why are only two sites (in New York and Washington) recruiting in the "international" poziotinib study? Down from many more before...
https://clinicaltrials.gov/ct2/show/study/NCT03318939?term=poziotinib&draw=3&rank=3#contacts
I bet there will be a turnaround before zero.
Awful name!!
I added to my trading position just below $17.
There are some points that drove the price down yesterday:
1. expectations were way too high. Easy game for the shorts.
2. misunderstanding of ORR (prior data was unconfirmed RR, data from yesterday was confirmed), you can't compare unconfirmed (1 scan) to confirmed (2 scans)
3. The AE rate is very very high. The low discontinuation rate could be meaningless and just because MD Anderson is treating patients very well. I expect a much higher disc. rate in the two SPPI trials, another reason is that they upped the dose after dose reduction from 16/12/8 (MD Anderson) to 16/14/12 (SPPI trials).
4. there is better competition in HER2 exon20 as we saw on the conference. poziotinib isn't best in class there.
Nevertheless, chances of BTD in EGFR exon 20 IMHO are 75%. Worth speculating.
Ville-O-Meter: 10 Points!
Well below 20 and dropping further.
>50% and mPFS > 6months plus fewer g3/4/5 AE is always a sure thing for BTD in a indication with unmet need. But we are not there...
Data is still good but not that fantastic anymore. BTD is not a sure thing anymore, but likely.
No mention in press release about BTD.
I re-checked the sentiment and expectations across the internet.
The sentiment is super-bullish, the expectations are very very high. On the other side we know 95% of what is coming tonight - so no suprises like last year.
So i wouldn't be suprised by an unexepected market reaction and a resulting share price well below $20.
Mr. Market always goes the road with the largest pain.
projection for tomorrow
Unlike last year where the really high ORR data caught many off guard this year is different.
You just have too take a look at the yahoo message board, the sentiment is euphoric. Some really did believe in a $60+ buyout after fridays close and were very very disappointed. They are over their head in this stock.
So i think there is only a slim chance that we will see new highs on close tomorrow.
My best guess is thats it will pop 10-20% and then fade.
20% chance: close at or below fridays close.
35% chance: close between 21.50 and 23
35% chance: close between 23 and 25
10% chance: close above 25
Even after today it got obvious that everything he said was lied, more than a dozend people over there still hang on his lips and believe everything he says because they just want to. It is unreal. How stupid can one be? If i was UK i would laugh the whole day about those stupid and greedy people.
58% ORR in EGFR (unconfirmed, so CONFIRMED will be lower); PFS 5.6 months. Down significantly from previous numbers.
50% in HER2; overshadowed by one possible drug related death.
Disappointing.
I am a MEDX veteran, too. They robbed us.
Isn't it the same with Turgeon as with Pien. Pien lived in California and the headquarter was in NJ. And Turgeon lives in Florida and the headquarter/operations are in Henderson and Irvine. Same motivation?
I would sell if i was him...he is not the youngest CEO on earth. I don't know if $50 would be too high for a fast sale.
Takeover Chatter
Give me $31 now and i'm okay.
The longer you wait the more i want.
antihama, there was an data abstract at WCLC 2017. The data of this abstract was updated to a larger number of patients at the conference presentation. So far so good, this is usual.
This time it is only an trial abstract at ASCO. Not a data abstract. This time is different.
Impossible under ASCO rules. Just believe me.
No. There are abstracts for data release and there are abstracts to publish infos about new trials. This is about the new trial. It is usual to present new trials and their trial design at ASCO. That's what they do here. Don't expect data.
Is he finished with selling?
406 pts (ADVANCE) + 218 pts planned (RECOVER)
= 624 pts
Joe Turgeon says 800 pts in both phase 3 trials.
“The ADVANCE study is a cornerstone in the ROLONTIS clinical program, which includes two Phase 3 clinical studies involving approximately 800 patients,” said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals
Where is the error??
Or does he add the patients of the phase 1 and 2 trial? Then it would make sense.
todays press release says 800pts in two phase 3 trials!! Seems the second trial is as large as the first!! This puzzles me. Maybe they go for superiority?
Home > Investor Relations > Spectrum Pharmaceuticals Announces Detailed Results from Phase 3 Study of ROLONTIS® (eflapegrastim) Published in an ASCO Abstract
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May 16, 2018
Spectrum Pharmaceuticals Announces Detailed Results from Phase 3 Study of ROLONTIS® (eflapegrastim) Published in an ASCO Abstract
PDF Version
Primary endpoint of non-inferiority of ROLONTIS to pegfilgrastim was met
All secondary endpoints were met
Adverse events were similar between ROLONTIS and pegfilgrastim
ROLONTIS is a novel, long-acting granulocyte colony-stimulating factor (G-CSF) that utilizes a propriety technology
HENDERSON, Nev.--(BUSINESS WIRE)--May 16, 2018-- Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced detailed results from ADVANCE, a Phase 3 trial of ROLONTIS, demonstrating that it was non-inferior to pegfilgrastim in the reduction of duration of severe neutropenia (DSN) in all four cycles of the study. ROLONTIS is a novel long-acting granulocyte colony-stimulating factor (G-CSF) being studied as a treatment for neutropenia in patients undergoing myelosuppressive cytotoxic chemotherapy. The data released online today in an abstract as part of the American Society of Clinical Oncology 2018 Annual Meeting, also showed similar safety profiles between the treatment groups. The abstract can be find online at https://meetinglibrary.asco.org/record/163382/abstract.
“These data expand our understanding of the clinical profile of eflapegrastim and help establish it as a possible supportive care treatment option for the multitude of patients undergoing chemotherapy,” said Lee Schwartzberg, M.D., FACP, lead investigator, professor of medicine and division chief, hematology oncology, University of Tennessee Health Science Center, and executive director, UT/West Cancer Center. “The study demonstrated strong non-inferiority of ROLONTIS to pegfilgrastim, including a 95 percent confidence interval of the difference in the DSN below zero in the first cycle of treatment, helping further define the clinical profile of this novel treatment.”
In the ROLONTIS Phase 3 ADVANCE study (n=406), mean DSN±SD was 0.19±0.478 days for ROLONTIS and 0.34±0.668 days for pegfilgrastim, demonstrating non-inferiority with 95 percent confidence interval (CI) of ?DSN: [-0.260, -0.035]; p<0.0001) in Cycle 1. The non-inferiority of ROLONTIS for DSN was maintained across all four treatment cycles. There were no statistically significant differences in all secondary endpoints including time to absolute neutrophil count (ANC) recovery, depth of ANC nadir and incidence of febrile neutropenia in Cycle 1. The most common adverse events, which were observed in less than 10 percent of patients, were similar across both treatment groups and were mainly hematologic, including neutropenia, lymphopenia, anemia and leukopenia.
“The ADVANCE study is a cornerstone in the ROLONTIS clinical program, which includes two Phase 3 clinical studies involving approximately 800 patients,” said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. “We are pleased that ROLONTIS has shown strong non-inferiority data and comparable safety profile to the current standard of care. ROLONTIS has the potential to be the first novel drug in this multibillion dollar market in more than 15 years.”
the market seems to be with you :)
earnings and CC isn't important. The other items of the press release or the CC were known already. Nothing new but Rolontis abstract. Rolontis abstract and what i read within was a positive!
MASCC is about ADVANCE results. They only report Non-inferiority.
No mention of superiority results doesn't mean that superiority wasn't reached. There may be a possibility that they hold back superiority data because they wait if it is confirmed by the RECOVER study. But as i said: just (my) speculation.
Looking at the phase 2 data of Rolontis (n=36) and the phase 3 data of the first study i would like to see the superiority value for the phase 3 study.
With those values and n = 406 i think there could still be a chance to have met superiority in the first phase 3 study. They maybe just hit superiotrity and hold back this information til the second study hits, because they need to have superiority in both studies to have it in the label. Just a speculation.
Yes, but only online - so not really meaningful for the ASCO community.
Abstract at MASCC is out: no superiority! But good non-inferiority results. So the second study with smaller numbers should be positive.
https://masccmeeting.org/2018/abstracts/interactive-programm#.WutsykHD99A
SCIENTIFIC PROGRAMME
PS06 Parallel
Session 06: Challenges of Hemostasis in Cancer Patients
29-Jun-2018 09:05 10:35
Abstract: PS026
EFLAPEGRASTIM IS SAFE AND EFFECTIVE IN REDUCING SEVERE NEUTROPENIA IN PATIENTS RECEIVING MYELOSUPPRESSIVE CHEMOTHERAPY IN A PHASE 3 RANDOMIZED, CONTROLLED TRIAL COMPARED TO PEGFILGRASTIM (ADVANCE)
Introduction:
Eflapegrastim is a novel investigational biologic comprised of recombinant human G-CSF covalently linked to the human immunoglobulin G4FC fragment using proprietary LAPSCOVERY™ technology.
Objectives
This study was a randomized, Phase 3 study to demonstrate the non-inferiority (NI) of eflapegrastim to pegfilgrastim in patients receiving chemotherapy for breast cancer.
Methods
Patients with Stage I to Stage IIIA breast cancer were treated with a single subcutaneous dose of either eflapegrastim 13.2 mg/0.6 mL or pegfilgrastim (6 mg) in a 1:1 ratio on Day 2 of each of four cycles following adjuvant/neo-adjuvant docetaxel and cyclophosphamide (TC) on Day 1. The primary endpoint was to demonstrate non-inferiority of eflapegrastim as measured by the mean duration of severe neutropenia (DSN) in Cycle 1 with NI margin of <0.62 day.
Results
In a total of 406 intent-to-treat patients (randomized to 196 eflapegrastim; 210 pegfilgrastim), median age was 61 years (range 24 to 84 years); mean (SD) DSN was 0.19 (0.478) days for eflapegrastim and 0.34 (0.668) days for pegfilgrastim, demonstrating the non-inferiority (95% CI of ?DSN: [-0.260, -0.035]; p<0.0001). The non-inferiority of eflapegrastim for DSN was maintained across all 4 cycles. The adverse events observed in ≥10% of patients were similar across both arms and were mainly hematologic including neutropenia, decreased lymphocytes, anemia and leukopenia.
Conclusions
Eflapegrastim, a novel long acting G-CSF was non-inferior to pegfilgrastim in the reduction of DSN in Cycles 1-4, in breast cancer patients treated with TC. Eflapegrastim was safe and well-tolerated with a similar safety profile to pegfilgrastim.
Co-authors
L. Schwartzberg 1, G. Bhat 2, J. Peguero 3, R. Agajanian 4, J. Bharadwaj 5, A. Restrepo 6, O. Hlalah 7, I. Mehmi 8, Z. Yang 9, P. Cobb 10
1University of Tennessee Health Sciences Center, Division of Hematology/Oncology, Memphis, USA
2Spectrum Pharmaceuticals- Inc., Biostatistics- Data Management- and Medical Writing, Irvine, USA
3Oncology Consultants PA, Department of Research, Houston, USA
4The Oncology Institute of Hope and Innovation, Hematology/Oncology, Downey, USA
5Pacific Cancer Medical Center, Hematologic Oncology, Anaheim, USA
6Texas Oncology, Medical Oncology, McAllen, USA
7Bond Clinic, Oncology and Hematology, Winter Haven, USA
8Edwards Comprehensive Cancer Center, Hematology/Oncology, Huntington, USA
9Spectrum Pharmaceuticals- Inc., Clinical Development, Irvine, USA
10Frontier Cancer Center, Hematology/Oncology, Billings, USA
After the unconfirmed responses of the 11 pts were initially that high (70-75%) i was hoping for durations in the same range as normal TKIs - PFS = 10 to 15 months.
But i guess with more and more mature data we will see around 6 or 7 months at best. And the high response rate will come down to 40-50% (confirmed) which would still be good enough for BTD.
I am still disappointed regarding Rolontis not accepted for ASCO presentation - despite JT saying in Feb that they have submitted an abstract. There are maybe some bad issues with the rolontis data.
ASCO abstract titles 2018 out - 5min ago
... but no eflapegrastim or Rolontis abstract !!!
Not good!
Addition: At time of the data cutoff for the latest press release ("at 6.5 months PFS for 11 pts not reached") we only know that less than 6 patients progressed so far. We don't know more. So the number of progressers at that point of time could be 0, 1, 2, 3, 4 or 5. Number 6 triggers the PFS event which is determined by
PFS patient 5 + PFS patient 6
------------------------------
2
PFS = length in time{ date(progression) - date(start) }
No, this was just a general question. It is a waste of time to contact them. This co. has the worst IR on earth: none.
Has someone tried to contact the IR and to get an answer to his/her question since Joe Turgeon took over? This is something they really have to fix. This always is/was an absolute NO-GO!