January 2, 2017: Biotechnology firm Immunogen announced that results from the Phase 1 expansion cohort evaluating mirvetuximab soravtansine (IMGN853) in patients with folate receptor alpha (FRa)-positive platinum-resistant ovarian cancer were published in the Journal of Clinical Oncology. The data demonstrate the potential clinical benefit of mirvetuximab soravtansine for the treatment of platinum-resistant ovarian cancer.
Immunogen said, “Standard single-agent therapy for patients with platinum-resistant ovarian cancer typically has a response rate below 20% and median progression-free survival below four months. Mirvetuximab soravtansine generated encouraging efficacy and tolerability data in the Phase 1 trial that suggest the potential to improve clinical outcomes for this patient population.”
The Phase 1 expansion cohort enrolled 46 patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer whose tumors were positive for FRa. Patients were dosed with mirvetuximab soravtansine once every three weeks. Mirvetuximab soravtansine demonstrated single-agent activity in the 46-patient cohort with a 26% confirmed response rate and median progression free survival (PFS) of 4.8 months. In a subset of 23 patients with low, medium or high FRa, who had received three or fewer prior lines of therapy, there was a 39% objective response rate (ORR) and median PFS of 6.7 months. On the basis of the study findings and additional data demonstrating the importance of FRa expression levels with mirvetuximab soravtansine, the Company has designed the Phase 3 FORWARD I study to enroll patients with platinum-resistant ovarian cancer with one to three prior therapies and with medium or high FRa. This group of patients in the Phase 1 expansion cohort exhibited a 44% ORR and a median PFS of 6.7 months.
Mirvetuximab soravtansine exhibited a manageable safety profile. Adverse events (AEs) were generally mild with the majority being grade 1 or grade 2 (least severe grades). The most commonly observed AEs were diarrhea, blurred vision, nausea, and fatigue.
Immunogen said, “These results demonstrate that mirvetuximab soravtansine is active in platinum-resistant ovarian cancer, with encouraging response rates and progression-free survival combined with a manageable safety profile. On the basis of these findings, we have moved confidently into a Phase 3 registration study evaluating this promising agent against the standard of care in the platinum-resistant setting. In addition, we are evaluating combination regimens to assess mirvetuximab soravtansine in expanded patient populations and will begin reporting data from these combinations in mid-2017.”
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ImmunoGen, Inc. develops targeted anticancer therapeutics. The Company’s ADC technology uses tumor-targeting antibodies to deliver an ImmunoGen cell-killing agent specifically to cancer cells.