FDA requires new phase III trial for mirvetuximab soravtansine for patients with (FR alpha)-positive

ImmunoGen, Inc.,has announced the FDA has recommended that the Company conduct a new Phase III randomized trial to evaluate the safety and efficacy of mirvetuximab soravtansine in patients with high folate receptor alpha (FR alpha)-positive, platinum-resistant ovarian cancer as part of a Type C meeting held this week.

ImmunoGen requested the meeting to discuss the results of the Phase III FORWARD I trial and a potential path to registration for mirvetuximab monotherapy. The agency advised that, because FORWARD I did not meet its primary endpoint under the pre-specified statistical analysis plan, the data generated assessing the secondary endpoints from the study could not be used to support an application for accelerated approval. The FDA acknowledged that platinum-resistant ovarian cancer is a disease with unmet need, provided guidance regarding the design and endpoints of a potential registration study, and encouraged the Company to return to discuss a proposed study design.