ImmunoGen shares soared 46% Tuesday after the cancer drug specialists said its ovarian cancer treatment met the primary goals of a late-stage study.
ImmunoGen said mirvetuximab, its treatment for patients with platinum-resistant ovarian cancer, performed well in a pivotal SORAYA trial. Mirvetuximab had a confirmed objective response rate (ORR) of 32.4%, the drugmaker said, with a duration of response of 5.9 months in the 106-person trial.
ImmunoGen said the data would be submitted to the U.S. Food & Drug Administration as party of the agency's' Biologics License Application process in the first quarter of next year.
"This is an exciting moment, both for the field of ovarian cancer and for ImmunoGen, and the outcomes from SORAYA further validate our longstanding history of innovation in ADCs," said ECEO Mark Enyedy. "We are moving forward expeditiously to complete the BLA for mirvetuximab, with the goal of submitting the application to FDA for accelerated approval in the first quarter of 2022. In parallel, commercial preparations are well underway to support the potential launch of mirvetuximab next year."
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