ImmunoGen ADC hits mark in ovarian cancer subgroup, heads for FDA

Tuesday’s readout for mirvetuximab addresses a smaller ovarian cancer population than ImmunoGen had originally sought to treat, but still positions the biotech for a regulatory submission next quarter seeking accelerated approval.

ImmunoGen Inc. (NASDAQ:IMGN) said the antibody-drug conjugate led to an investigator-assessed objective response rate of 32.4% in the SORAYA trial, meeting its primary endpoint. The single-arm Phase III study was designed to assess whether mirvetuximab soravtansine would outperform the 12% ORR expected from chemotherapy among ovarian cancer patients with high FOLR1 expression, based on the control arm of a prior trial...