ImmunoGen: FDA recommends new Phase 3 trial of mirvetuximab soravtansine
ImunoGen announced the United States FDA has recommended that the company conduct a new Phase 3 randomized trial to evaluate the safety and efficacy of mirvetuximab soravtansine in patients with high folate receptor 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 3 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. 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.