They Had nice results on their bladder cancer drug. I think there is a good shot it gets approved. They are also doing a testing with their drug combined with one of astrazeneca's. I think they are looking to hear from the FDA by the end of this year or earlier.
Additionally, Sesen Bio believes that cancer cell-killing properties of Vicinium promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicinium in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.
Sesen Bio Reports Positive, Preliminary Data Update from Phase 3 VISTA Trial for High-Risk Non-Muscle Invasive Bladder Cancer
August 8, 2019 at 4:01 PM EDT
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Updated 12-month Phase 3 Data will Serve as the Basis for Submission of the BLA
On Track for Anticipated Initiation of BLA Submission in 4Q 2019
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Aug. 8, 2019-- Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today reported updated, preliminary primary and secondary endpoint data from the Company’s Phase 3 VISTA trial further supporting the strong benefit-risk profile of Viciniumfor the potential treatment of patients with high-risk,bacillus Calmette-Guérin(BCG) unresponsive, non-muscle invasive bladder cancer (NMIBC). The updated preliminary Phase 3 clinical data will serve as the basis for the anticipated initiation of the Company’s BLA submission in 4Q 2019.
“After two very positive meetings with the FDA in the second quarter, we are now focused on initiating the BLA submission for Vicinium in the fourth quarter under an Accelerated Approval pathway with Rolling Review,” said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. “We believe this regulatory pathway and our strong 12-month Phase 3 data could potentially expedite patient access to Vicinium, which is particularly important in light of the ongoing BCG shortage. We look forward to our two additional face-to-face meetings with the FDA in the fourth quarter as we work to bring Vicinium to market to help save and improve the lives of patients with NMIBC.”
Phase 3 VISTA Trial Progress
Updated Primary and Secondary Endpoint Data from Phase 3 VISTA Trial Support a Growing Body of Evidence Demonstrating the Clinically Meaningful Anti-tumor Activity of Vicinium: In May, Sesen Bio announced updated preliminary data from its ongoing Phase 3 VISTA trial, a single-arm, 24-month, multi-center clinical trial designed to support the approval of Vicinium for the treatment of patients with high-risk, BCG-unresponsive NMIBC.The trial completed registration in the second quarter of 2018, with a total of 133 patients across three cohorts based on histology and time to disease recurrence after adequate BCG treatment (at least two courses of BCG with at least five doses in the first course and two doses in the second course). Primary efficacy endpoints consist of complete response rate and duration of response for patients in Cohort 1. Secondary efficacy endpoints include time to disease recurrence for patients in Cohort 3, and time to cystectomy, progression-free survival, event-free survival, and overall survival for patients across all cohorts. As of the May 29, 2019 data cut, updated preliminary primary and secondary efficacy data for each of the trial cohorts were as follows:
Cohort 1 Complete Response Rate, Evaluable Population
Time point
Evaluable Patients*
Complete Response Rate
3-months
n=82
39%
6-months
n=82
26%
9-months
n=82
20%
12-months
n=82
17%
Patients with Carcinoma in situ with or without papillary disease that was determined to be refractory or recurred within six months of their last course of adequate BCG.
*Response-evaluable population includes any modified intention to treat (mITT) subject who completed the induction phase.
Cohort 2 Complete Response Rate, Evaluable Population
Time point
Evaluable Patients*
Complete Response Rate
3-months
n=7
57%
6-months
n=7
57%
9-months
n=7
43%
12-months
n=7
14%
Patients with Carcinoma in situ with or without papillary disease that was determined to be refractory or recurred after six months, but less than or equal to 11 months, after their last course of adequate BCG.
*Response-evaluable population includes any mITT subject who completed the induction phase.
Pooled Cohorts 1 and 2 Complete Response Rate, Evaluable Population
Time point
Evaluable Patients*
Complete Response Rate
(95% Confidence Interval)
3-months
n=89
40% (30%- 51%)
6-months
n=89
28% (19%-39%)
9-months
n=89
21% (13%-31%)
12-months
n=89
17% (10%-26%)
Patients with Carcinoma in situ with or without papillary disease that was determined to be refractory or recurred less than 11 months after their last course of adequate BCG.
*Response-evaluable population includes any mITT subject who completed the induction phase.
Duration of Response: The median duration of response for patients in Cohort 1 (n=86) is 273 days (95% CI, 122-NA), using the Kaplan-Meier method. Additional ad hoc analysis of pooled data for all patients with Carcinoma in situ (Cohorts 1 and 2, n=93) shows that among patients who achieved a complete response at 3 months, 52% had a complete response for a total of 12 months or longer after starting therapy, using the Kaplan-Meier method.
Time to Disease Recurrence: High-risk papillary (Ta or T1) NMIBC is associated with higher rates of progression and recurrence. Therefore, time to disease recurrence is a key secondary endpoint for patients with high-risk papillary-only NMIBC. The median time to disease recurrence for patients in Cohort 3 (n=40) is 402 days (95% CI, 170-NA), using the Kaplan-Meier method.
Time to Cystectomy: The FDA guidance states that the goal of therapy in patients with BCG-unresponsive NMIBC is to avoid cystectomy. Therefore, time to cystectomy is a key secondary endpoint in the VISTA trial. Across all 133 patients treated with Vicinium, >75% of patients are estimated to remain cystectomy-free at 2.5 years, using the Kaplan-Meier method. Additional ad hoc analysis of responders and non-responders for all patients shows that approximately 88% of responders are estimated to remain cystectomy-free at 3 years.
Progression-Free Survival: 90% of all 133 patients treated with Vicinium are estimated to remain progression-free for 2 years or greater, using the Kaplan-Meier method. Progression-free is defined as the time from the date of first dose of study treatment to disease progression (e.g. T2 or more advanced disease) or death as a first event.
Event-Free Survival: 29% of all 133 patients treated with Vicinium are estimated to remain event-free at 12 months, using the Kaplan-Meier method. Event-free survival is defined as the time from the date of first dose of study treatment to disease recurrence, progression, or death as a first event.
Overall Survival: 96% of all 133 patients treated with Vicinium are estimated to have an overall survival of 2 years or greater, using the Kaplan-Meier method. Overall survival is defined as the time from the date of first dose of study treatment to death from any cause.
Vicinium Continues to be Well-tolerated by Patients in the Phase 3 VISTA Trial: As of the May 29, 2019 data cut, in patients across all cohorts (n=133), 95% of adverse events were Grade 1 or 2. The most commonly reported treatment-related adverse events were dysuria (14%), hematuria (13%) and urinary tract infection (12%) – all of which are consistent with the profile of bladder cancer patients and the use of catheterization for treatment administration. These adverse events were determined by the clinical investigators to be manageable and reversible, and only four patients (3%) discontinued treatment due to an adverse event. Serious adverse events (SAEs), regardless of treatment attribution, were reported in 14% of patients. There were four treatment-related SAEs reported in three patients including acute kidney injury (Grade 3), pyrexia (Grade 2), cholestatic hepatitis (Grade 4) and renal failure (Grade 5). There were no age-related increases in adverse events observed in the Phase 3 VISTA trial.
Vicinium Regulatory Pathway Updates
Bulk Drug Substance from the Full-Scale GMP Manufacturing Run at FUJIFILM Met all Phase 3 Quality Release Specifications: In April 2019, the first full, commercial-scale GMP run was completed at FUJIFILM Diosynth Biotechnologies U.S.A., Inc (FUJIFILM). Release testing of the bulk drug substance has been completed and all Phase 3 release specifications were met, further de-risking the Company’s manufacturing technology transfer to FUJIFILM and the Company’s Analytical Comparability Plan.
Recent positive interactions with the FDA reaffirm the Company’s confidence in the regulatory and commercial pathway for Vicinium
Type C CMC Meeting held on May 20, 2019. In conjunction with the technology transfer of Vicinium production to FUJIFILM, the Company has reached agreement with the FDA on the Analytical Comparability Plan, and that, subject to final comparability data to be provided in the BLA submission, no additional clinical trials to establish comparability are deemed necessary at this time.
Pre-BLA Meeting held on June 6, 2019. The Company has reached alignment with the FDA on the regulatory approval pathway for Vicinium:
The clinical, nonclinical and clinical pharmacology data, as well as the safety database, are sufficient to support a BLA submission, and no additional clinical trials are necessary for a BLA submission.
FDA recommended submission under an Accelerated Approval Pathway and Rolling Review.
Per the official FDA minutes received post-meeting, the FDA stated that the pre-approval inspection (PAI) may be completed at the time of PPQ manufacturing, which the Company believes will further de-risk the CMC review timeline.
Expected Advisory Committee (ODAC) meeting post-BLA submission to review the benefit-risk profile of Vicinium, given there have been no product approvals in this indication in the past twenty years.
Key Upcoming Corporate Milestones:
Type B CMC meeting to align on the submission strategy of CMC Module 3.
Type C meeting to discuss the details of a post-marketing confirmatory trial in support of the Accelerated Approval Pathway for Vicinium.
Initiation of BLA submission including nonclinical and clinical modules 1, 2, 4 and 5.
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