Dr. Matulonis on the FDA Approval of Mirvetuximab Soravtansine in Frα+ Platinum-resistant Ovarian Cancer

Ursula A. Matulonis, MD, chief, Division of Gynecologic Oncology, Brock-Wilson Family Chair, Dana-Farber Cancer Institute; professor, medicine, Harvard Medical School, discusses the significance of the FDA approval of mirvetuximab soravtansine-gynx (Elahere) in patients with folate receptor α (Frα)–positive, platinum-resistant ovarian cancer.

On November 14, 2022, the FDA granted accelerated approval to mirvetuximab soravtansine in adult patients with Frα-positive, platinum-resistant epithelial ovarian, primary peritoneal, or fallopian tube cancer who have received 1 to 3 prior systemic treatments. The regulatory decision was based on findings from the phase 3 SORAYA trial (NCT04296890), in which the agent demonstrated an objective response rate of 31.7% and a duration of response of 6.9 months.

The FDA has greenlit the first new therapy for platinum-resistant ovarian cancer since the 2014 approval of bevacizumab (Avastin) plus chemotherapy, Matulonis says. Mirvetuximab soravtansine is also the first antibody-drug conjugate approved for ovarian cancer, and 1 of the first biomarker-driven treatments for this disease, as bevacizumab and PARP inhibitors do not have specific biomarkers, Matulonis explains.

High levels of Frα expression are crucial for the efficacy of mirvetuximab soravtansine, and preselecting patients with this biomarker is important, Matulonis emphasizes. Early Frα testing can determine Frα levels that are high and not medium or low, so that when the appropriate time comes to consider this agent in certain patients, they are already screened and their eligibility is predetermined, Matulonis concludes.