ImmunoGen, Inc. (NASDAQ:IMGN) announced data from a 46-patient phase I cohort evaluating the efficacy and safety of mirvetuximab soravtansine as a single-agent therapy for platinum-resistant, folate receptor alpha (FRα)-positive ovarian cancer.
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The phase I cohort enrolled patients with platinum-resistant ovarian cancer who had received up to five previous treatment regimens. Moreover, patients were classified as having low, medium, or high FRα expression based on the % of tumor cells meeting this criterion (25–49%, 50–74%, and 75–100%, respectively).
Data showed that all 46 patients demonstrated an objective response rate (ORR) of 26% and a median progression-free survival (PFS) of 4.8 months. While among the 16 patients who received up to three prior regimens and had high or medium FRα expression, the ORR was found to be 44% and median PFS was 6.7 months. Moreover, 30 patients who had low FRα and/or who had received four or five prior regimens, ORR was 17% while median PFS was 4.2 months. On the safety front, the candidate was found to be well tolerated with most side effects being Grade 1 or 2 (least severe grades).
ImmunoGen intends to present this data at the annual meeting of the American Society of Clinical Oncology next month. Based on full results from the 46-patient ovarian cancer cohort, the company has submitted a meeting request to the FDA to discuss about the path forward. The company anticipates the meeting to occur in early third-quarter 2016 and initiate a phase III study (FORWARD I) on mirvetuximab soravtansine in the fourth quarter of 2016, following discussions with the regulatory agency.
The phase III study will evaluate mirvetuximab soravtansine as a single-agent therapy for platinum-resistant ovarian cancer and enrol patients who previously received up to three treatment regimens and whose cancer has high or medium FRα expression. The primary endpoint of the study will be PFS.
We are encouraged by the company’s progress with the candidate. Per data provided by the American Cancer Society, approximately 22,300 new cases of ovarian cancer are likely to be diagnosed in the U.S. in 2016 resulting in more than 14,200 deaths.
Meanwhile, mirvetuximab soravtansine is also in phase Ib/II development in combination with other regimens for the treatment of ovarian cancer.
Being the company’s lead candidate, we expect investor focus to remain on updates pertaining to the development of mirvetuximab soravtansine.
ImmunoGen is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include Retrophin, Inc. (NASDAQ:RTRX) , ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) and Bristol-Myers Squibb Company (NYSE:BMY) . All three stocks sport a Zacks Rank #1 (Strong Buy).
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