ImmunoGen (NASDAQ:IMGN) announces that the FDA has advised that a new single-arm study in platinum-resistant ovarian cancer could support accelerated approval for mirvetuximab soravtansine.
Based on this guidance, the company will initiate SORAYA, a trial to evaluate mirvetuximab monotherapy in women with folate receptor alpha (FRĪ±)-high platinum-resistant ovarian cancer who have been previously treated with Avastin (bevacizumab).
The Company anticipates enrolling first patient in the study in next quarter with top-line data expected in mid-2021.
The trial will enroll approx. 100 patients. The primary endpoint is overall response rate by investigator assessment and the key secondary endpoint is duration of response.
Shares are up 27% premarket.
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