ImmunoGen Inc. (IMGN) announced full results from the pivotal SORAYA trial evaluating the efficacy and safety of mirvetuximab soravtansine (mirvetuximab) monotherapy in patients with folate receptor alpha (FRa)-high platinum-resistant ovarian cancer who have been previously treated with Avastin or bevacizumab.
The trial met primary endpoint with confirmed objective response rate of 32.4%, including 5 complete responses; updated median duration of response of 6.9 months.
The company noted that Mirvetuximab demonstrated meaningful anti-tumor activity, consistent safety, and favorable tolerability in fra-high platinum-resistant ovarian cancer.
The company expects to submit Biologics License Application in this month.
Mirvetuximab soravtansine (IMGN853) is a first-in-class ADC comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin-targeting agent, to kill the targeted cancer cells.
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