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 is supplied as a single-dose vial containing 100mg/20mL solution of mirvetuximab soravtansine-gynx. Treatment is administered as an intravenous infusion following dilution.

Patients should be selected for treatment based on the presence of FRα tumor expression. The FDA has approved the Ventana FOLR1 (FOLR1-2.1) RxDx Assay (Roche) as a companion diagnostic test to aid in identifying epithelial ovarian cancer patients who are eligible for targeted treatment with Elahere.

References

  1. ImmunoGen announces FDA accelerated approval of Elahere™ (mirvetuximab soravtansine-gynx) for the treatment of platinum-resistant ovarian cancer. News release. ImmunoGen. November 14, 2022. Accessed November 15, 2022. https://www.businesswire.com/news/home/20221104005657/en/ImmunoGen-Announces-FDA-Accelerated-Approval-of-ELAHERE%E2%84%A2-mirvetuximab-soravtansine-gynx-for-the-Treatment-of-Platinum-Resistant-Ovarian-Cancer
  2. Roche receives FDA approval for Ventana FOLR1 (FOLR1-2.1) RxDx Assay as the first IHC-based companion diagnostic to identify ovarian cancer patients eligible for Elahere. News release. Company. Accessed August 1, 2022. https://www.prnewswire.com/news-releases/roche-receives-fda-approval-for-ventana-folr1-folr1-2-1-rxdx-assay-as-the-first-ihc-based-companion-diagnostic-to-identify-ovarian-cancer-patients-eligible-for-elahere-301677740.html
  3. Elahere. Package insert. ImmunoGen; 2022. Accessed November 15, 2022. https://www.immunogen.com/wp-content/uploads/2022/11/ELAHERE_PI.pdf