IMGN - Immunogen eyes ovarian cancer pivotal trial data release this quarter BLA in Q1 2022

ImmunoGen (NASDAQ:IMGN) says it anticipates releasing top-line phase 3 data on its lead candidate, mirvetuximab soravtansine, for platinum-resistant ovarian cancer this quarter, with a BLA submission in Q1 2022. The trial, SORAYA, is evaluating mirvetuximab as monotherapy in a single-arm study. The primary endpoint is overall response rate and the secondary endpoint of duration of response. If results are positive, ImmunoGen said accelerated approval of the candidate could come next year. ImmunoGen also said that it would report top-line data on another mirvetuximab trial, MIRASOL, in Q3 2022. That trial is evaluating the monoclonal antibody as a monotherapy but in a randomized study. The company said that its current cash on hand of ~$245.8M is enough to fund operations through the end of 2022. ImmunoGen also reaffirmed its revenue guidance for the year.

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Immunogen eyes ovarian cancer pivotal trial data release this quarter, BLA in Q1 2022