FDA Approves Mirvetuximab Soravtansine in FRα+ Ovarian Cancer

Supporting data for this approval came from the phase 3 MIRASOL trial (NCT04209855).

The FDA has granted approval to mirvetuximab soravtansine-gynx (Elahere) as a treatment for patients with folate receptor alpha (FRα)–positive platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer previously treated with 1 to 3 previous lines of therapy.¹

Supporting data for this approval came from the phase 3 MIRASOL trial (NCT04209855). Findings highlighted a median overall survival (OS) of 16.5 months (95% CI, 14.5-24.6) with mirvetuximab soravtansine vs 12.7 months (95% CI, 10.9-14.4) with investigator’s choice of chemotherapy (HR, 0.67; 95% CI, 0.50-0.88; P = .0046). Additionally, the median progression-free survival (PFS) in each respective arm was 5.6 months (95% CI, 4.3-5.9) and 4.0 months (95% CI, 2.9-4.5; HR, 0.65; 95% CI, 0.52-0.81; P <.0001). The overall response rate (ORR) in each respective arm was 42% (95% CI, 36%-49%) vs 16% (95% CI, 12%-22%; P <.0001).

Common adverse effects associated with mirvetuximab soravtansine include aspartate aminotransferase increases, fatigue, blurred vision, nausea, diarrhea, abdominal pain, peripheral neuropathy, decreased platelets, and constipation.

In the MIRASOL trial, 453 patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer were randomly assigned 1:1 to receive mirvetuximab soravtansine at 6 mg/kg intravenously every 3 weeks or chemotherapy with paclitaxel, pegylated liposomal doxorubicin, or topotecan. Study treatment continued until progressive disease or unacceptable toxicity.

The trial’s major end points included investigator-assessed PFS and OS per RECIST v1.1 guidelines as well as ORR.

The FDA previously granted accelerated approval to mirvetuximab soravtansine as a treatment for the aforementioned population following 1 to 3 prior lines of treatment in November 2022.² The accelerated approval was based on findings from the phase 3 SORAYA trial (NCT04296890). Findings from the MIRASOL trial were intended to fulfill the post-marketing requirements of the accelerated approval of mirvetuximab soravtansine.

References

1. FDA approves mirvetuximab soravtansine-gynx for FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. News release. FDA. March 22, 2024. Accessed March 22, 2024. https://tinyurl.com/2apx6e5s
2. FDA grants accelerated approval to mirvetuximab soravtansine-gynx for FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or peritoneal cancer. News release. FDA. November 14, 2022. Accessed March 22, 2024. https://tinyurl.com/ykzyyup8