ImmunoGen Reports Positive Results from SORAYA Trial of Mirvetuximab Soravtansine in Patients with FRα-High Platinum-Resistant Ovarian Cancer

ImmunoGen reported positive topline results from the phase 3 SORAYA trial evaluating mirvetuximab soravtansine (mirvetuximab) monotherapy in patients with folate receptor alpha (FRα)-high platinum-resistant ovarian cancer who have been previously treated with Avastin (bevacizumab). The trial met the primary endpoint with a confirmed Objective Response Rate of 32.4%, and a duration of response of around six months. The treatment-related discontinuation rate was below 10%. ImmunoGen plans to submit a BLA application to FDA for accelerated approval in the first quarter of 2022.

The SORAYA trial was conducted at the recommendation of the FDA following analysis of the phase 3 FORWARD I trial, which was conducted in patients with platinum-resistant ovarian cancer that expresses medium or high levels of FRα. The FORWARD 1 trial failed to meet the primary endpoint but did show anti-tumor activity and a favorable benefit-risk profile in patients with high FRα expression.

SORAYA was a single-arm study of mirvetuximab in patients (n=106) with platinum-resistant ovarian cancer whose tumors express high levels of FRα and who have been treated with up to three prior regimens – at least on...

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