Mirvetuximab Soravtansine for FRα+ Platinum-Resistant Ovarian Cancer Gets Full FDA Approval

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Mirvetuximab soravtansine-gynx (Elahere) was first granted FDA accelerated approval in November 2022.

The FDA has granted regular approval to mirvetuximab soravtansine-gynx (Elahere) for adult patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have previously received one to three systemic treatment regimens.1

mirvetuximab soravtansine-gynx (Elahere) was first granted FDA accelerated approval in November 2022 / wladimir1804 - stock.adobe.com

mirvetuximab soravtansine-gynx (Elahere) was first granted FDA accelerated approval in November 2022 / wladimir1804 - stock.adobe.com

The regulatory decision is supported by data from the phase 3 MIRASOL study (NCT04209855) in which the antibody-drug conjugate (ADC) improved median overall survival (OS) vs investigator's choice of chemotherapy, at 16.5 months (95% CI, 14.5-24.6) vs 12.7 months (95% CI, 10.9-14.4), respectively (HR, 0.67; 95% CI, 0.50-0.88; P = .0046).

About MIRASOL

Trial Name: A Study of Mirvetuximab Soravtansine vs. Investigator's Choice of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression (MIRASOL)

ClinicalTrials.gov Identifier: NCT04209855

Sponsor: ImmunoGen

Summary: This Phase 3 study is designed to compare the efficacy and safety of mirvetuximab soravtansine vs. investigator's choice chemotherapy in patients with platinum-resistant high-grade epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of FRα. Patients will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy. Folate receptor alpha (FRα) positivity will be defined by the Ventana FOLR1 (FOLR1-2.1) CDx assay.

READ MORE: FDA Approves Lisocabtagene Maraleucel For Treatment of Relapsed or Refractory CLL, SLL

Mirvetuximab soravtansine also improved progression-free survival (PFS) vs chemotherapy, at a median of 5.6 months (95% CI, 4.3-5.9) vs 4.0 months (95% CI, 2.9-4.5), respectively (HR, 0.65; 95% CI, 0.52-0.81; P < .0001). Moreover, the ADC elicited an objective response rate of 42% (95% CI, 36%-49%) vs 16% (95% CI, 12%-22%) with chemotherapy (P < .0001).

Regarding safety, the most common adverse effects experienced by at least 20% of those who received mirvetuximab soravtansine included increased aspartate aminotransferase, fatigue, increased alanine aminotransferase, blurred vision, nausea, increased alkaline phosphatase, diarrhea, abdominal pain, keratopathy, peripheral neuropathy, musculoskeletal pain, decreased lymphocytes, decreased platelets, decreased magnesium, decreased hemoglobin, dry eye, constipation, decreased leukocytes, vomiting, decreased albumin, decreased appetite, and decreased neutrophils.2

READ MORE: Oncology Resource Center

This article originally appeared on OncLive.

References
1. FDA approves mirvetuximab soravtansine-gynx for FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. FDA. Accessed March 22, 2024. Accessed March 22, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirvetuximab-soravtansine-gynx-fra-positive-platinum-resistant-epithelial-ovarian
2. Elahere. Prescribing information. ImmunoGen, Inc.; 2024. Accessed March 22, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761310Origs005lbl.pdf
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