On November 14, 2022, the Food and Drug Administration granted accelerated approval to mirvetuximab soravtansine-gynx (Elahere, ImmunoGen, Inc.) for adult patients with folate receptor alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.
ELAHERE is a first-in-class ADC directed against FRα, a cell-surface protein highly expressed in ovarian cancer, and is the first FDA approved ADC for platinum-resistant disease.
Mirvetuximab soravtansine-gynx is a folate receptor alpha directed antibody and microtubule inhibitor conjugate. Patients are selected for therapy based on an FDA-approved test.
Efficacy was evaluated in Study 0417 (NCT04296890), a single-arm trial of 106 patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Patients were permitted to receive up to three prior lines of systemic therapy. All patients were required to have received bevacizumab. The trial enrolled patients whose tumors were positive for FRα expression as determined by the above assay.
Patients received mirvetuximab soravtansine-gynx 6 mg/kg (based on adjusted ideal body weight) as an intravenous infusion every three weeks until disease progression or unacceptable toxicity. Tumor response assessments occurred every six weeks for the first 36 weeks and every 12 weeks thereafter.
The main efficacy outcome measures were investigator-assessed overall response rate (ORR) and duration of response (DOR) evaluated according to RECIST version 1.1. In the efficacy evaluable population of patients who had platinum resistant, measurable disease, and received at least one dose (104 patients), the confirmed ORR was 31.7% (95% CI: 22.9, 41.6) and median DOR was 6.9 months (95% CI: 5.6, 9.7).
ABOUT ELAHERE (MIRVETUXIMAB SORAVTANSINE-GYNX)
ELAHERE (mirvetuximab soravtansine-gynx) is a first-in-class ADC comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells.
The recommended mirvetuximab soravtansine-gynx dose is 6 mg/kg adjusted ideal body weight (AIBW) administered once every three weeks (21-day cycle) as an intravenous infusion until disease progression or unacceptable toxicity.
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