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Trial Met Primary Endpoint with Confirmed Objective Response Rate of 32.4%, including 5 Complete Responses; Updated Median Duration of Response of 6.9 Months
Mirvetuximab Demonstrated Meaningful Anti-Tumor Activity, Consistent Safety, and Favorable Tolerability in FRα-High Platinum-Resistant Ovarian Cancer
BLA Submission Expected this Month
Investor Event to be Held on Sunday, March 20 at 7:30 am MST/10:30 am EDT
ImmunoGen, Inc. (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced full results from the pivotal SORAYA trial evaluating the efficacy and safety of mirvetuximab soravtansine (mirvetuximab) monotherapy in patients with folate receptor alpha ( FRα)-high platinum-resistant ovarian cancer who have been previously treated with Avastin® (bevacizumab). The results are being presented by Dr. Ursula Matulonis in the late-breaking abstract plenary session on Saturday, March 19 at the Society of Gynecologic Oncology (SGO) 2022 Annual Meeting in Phoenix, AZ.
“Patients with platinum-resistant ovarian cancer have limited treatment options, and these are associated with low response rates and significant toxicity,” said Ursula Matulonis, MD, Chief of the Division of Gynecologic Oncology at the Dana-Farber Cancer Institute, Professor of Medicine at the Harvard Medical School, and SORAYA Co-Principal Investigator. “With an objective response rate of 32.4%, far exceeding that seen with current therapies, and a median duration of response approaching seven months, mirvetuximab continues to demonstrate impressive efficacy in patients with platinum-resistant disease who have already received bevacizumab. The anti-tumor activity and consistent safety and tolerability data from the SORAYA trial further underscore the potential of mirvetuximab, if approved, to become a practice-changing, biomarker-driven standard of care for these patients.”
SORAYA is a single-arm study of mirvetuximab in patients with platinum-resistant ovarian cancer whose tumors express high levels of FRα and who have been treated with one to three prior regimens – at least one of which included bevacizumab. The primary endpoint for the study is confirmed objective response rate (ORR) as assessed by investigator and the key secondary endpoint is duration of response (DOR). ORR was also assessed by blinded independent central review (BICR). The study is designed to rule out a 12% ORR, based on expected outcomes of 4% to 13% with available single agent chemotherapy. Data previously generated in a post-hoc pooled analysis of seventy patients from prior studies of mirvetuximab in platinum-resistant disease formed the basis for the design of SORAYA, with an investigator-assessed ORR of 31.4%, median DOR of 7.8 months, and median progression-free survival (PFS) of 4.4 months.
Key Findings from SORAYA
SORAYA enrolled 106 patients with a median of three prior lines of therapy; 51% had three prior lines of therapy and 48% …
Full story available on Benzinga.com
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