The Food and Drug Administration (FDA) has granted accelerated approval to Elahere (mirvetuximab soravtansine-gynx) for the treatment of adult patients with folate receptor alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received 1 to 3 prior systemic treatment regimens.

Elahere is an antibody-drug conjugate comprised of a FRα-binding antibody, a cleavable linker, and a potent tubulin-targeting agent (maytansinoid payload DM4). The approval was based on data from the phase 3 SORAYA trial (ClinicalTrials.gov Identifier: NCT04296890), which evaluated the efficacy and safety of mirvetuximab soravtansine in 106 patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who previously received bevacizumab.

All patients received mirvetuximab soravtansine 6mg/kg as an intravenous infusion every 3 weeks until disease progression or unacceptable toxicity; the efficacy evaluable population included 104 patients.

Results showed a confirmed objective response rate (primary endpoint) of 31.7% (95% CI, 22.9-41.6), of which 4.8% (n=5) of patients achieved complete response and 26.9% achieved partial response. The median duration of response (secondary endpoint) was 6.9 months (95% CI, 5.6-9.7). The FDA’s accelerated approval was based on tumor response rate and durability of response; continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Elahere carries a Boxed Warning regarding ocular toxicity, including visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis. The most common adverse reactions reported with treatment include vision impairment, fatigue, increased AST/ALT, nausea, keratopathy, abdominal pain, decreased lymphocytes, peripheral neuropathy, diarrhea, decreased albumin, constipation, increased alkaline phosphatase, dry eye, decreased magnesium, decreased leukocytes, decreased neutrophils, and decreased hemoglobin.

Elahere Granted Accelerated Approval for Platinum-Resistant Ovarian Cancer

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