IMGN - ImmunoGen gains nearly a third on positive mirvetuximab data in ovarian cancer

ImmunoGen (NASDAQ:IMGN) soars 32.6% premarket after announcing positive top-line data from the SORAYA trial evaluating the safety and efficacy of mirvetuximab soravtansine (mirvetuximab) monotherapy in patients with folate receptor alpha (FR?)-high platinum-resistant ovarian cancer who have been previously treated with Avastin (bevacizumab). SORAYA enrolled 106 patients with a median of three prior lines of therapy. The trial met the primary endpoint with confirmed objective response rate (ORR) of 32.4% (95% confidence interval [CI]: 23.6%, 42.2%), including five complete responses (CRs). ORR by BICR was 31.6%, including five CRs. The median duration of response is currently 5.9 months (95% CI: 5.6, 7.7). Mirvetuximab was well-tolerated, consistent with the known safety profile seen in more than 700 patients treated in the broader mirvetuximab program. "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," said Mark Enyedy, ImmunoGen's President

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ImmunoGen gains nearly a third on positive mirvetuximab data in ovarian cancer