This is an edited version of an article written by Caroline Seymour and published on OncLive Nov. 15, 2022.
On November 14, 2022, the FDA granted accelerated approval to mirvetuximab soravtansine for the treatment of adult patients with folate receptor α (Frα)–positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received 1 to 3 prior systemic treatment regimens….
The approval is based on findings from the phase 3 SORAYA trial (NCT04296890), which enrolled 106 patients with platinum-resistant ovarian cancer whose tumors expressed high levels of FRα. Patients were allowed to have received up to 3 prior lines of systemic treatment, and all were required to have received bevacizumab (Avastin).
In the trial, patients received intravenous mirvetuximab soravtansine at 6 mg/kg once every 3 weeks until progressive disease or unacceptable toxicity. Tumor response assessments were performed every 6 weeks for the first 36 weeks, and every 12 weeks thereafter.
Confirmed investigator-assessed objective response rate (ORR) served as the primary end point, and the key secondary end point was duration of response (DOR) by RECIST v1.1 criteria.