ImmunoGen falls after modifying ovarian cancer trial
ImmunoGen Inc. (NASDAQ:IMGN) sank $1.60 (19%) to $6.85 on Friday after disclosing it is modifying the FORWARD I trial of its lead internal program, mirvetuximab soravtansine ( IMGN853). The company changed the study's eligibility criteria, primary endpoint and phase, and now hopes to seek full rather than accelerated approval in earlier lines of platinum-resistant ovarian cancer.
ImmunoGen said FORWARD I, which is evaluating mirvetuximab soravtansine as a single agent to treat folate receptor 1 ( FOLR1; FR-alpha)-positive platinum-resistant ovarian cancer, will now be a single-stage Phase III trial with progression-free survival (PFS) as the primary endpoint. It had intended FORWARD I to be a two-stage Phase II study with response rate as the primary endpoint to support accelerated approval. ...