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Mirvetuximab Soravtansine Approved for Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancers

Fallopian tube.

The FDA has granted accelerated approval to mirvetuximab soravtansine-gynx (Elahere®, ImmunoGen), a folate receptor alpha (FRα)–directed antibody and microtubule inhibitor conjugate, for patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancers previously treated with one to three systemic treatment regimens. In addition, the FDA approved the VENTANA FOLR1 RxDx Assay (Ventana Medical Systems, Inc.) as a companion diagnostic device for the selection of patients who are eligible to receive mirvetuximab soravtansine.

"Available single-agent chemotherapies for platinum-resistant ovarian cancer have limited clinical activity and considerable toxicity," wrote Ursula Matulonis, MD, Chief of the Division of Gynecologic Oncology at Dana-Farber Cancer Institute, and colleagues, in their 2022 Society of Gynecologic Oncology Annual Meeting abstract on the SORAYA trial (NCT04296890), on which the approval was based. "Mirvetuximab soravtansine is an antibody-drug conjugate comprising an FRα-binding antibody, cleavable linker, and maytansinoid DM4, a potent tubulin-targeting agent."

The single-arm, phase 3 trial enrolled 106 patients with FRα-high, platinum-resistant, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancers who had received one to three previous therapies, including bevacizumab. All patients received 6 mg/kg intravenous mirvetuximab soravtansine on Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity. The primary end point was objective response rate, with a secondary end point of duration of response.

Among 104 patients who had platinum-resistant, measurable disease and who received at least one dose, mirvetuximab soravtansine produced a confirmed objective response rate of 31.7%. The median duration of response was 6.9 months.

Adverse events and laboratory abnormalities occurring in ≥20% of patients included vision impairment, fatigue, increased aspartate aminotransferase, nausea, increased alanine aminotransferase, 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. The prescribing information for mirvetuximab soravtansine includes a boxed warning for ocular toxicity.

"In platinum-resistant epithelial ovarian, primary peritoneal, or fallopian tube cancers, where current therapies are suboptimal and biomarker-selected treatment has not been successfully developed, FRα expression predicts benefit from mirvetuximab soravtansine," concluded Dr. Matulonis and colleagues. "Mirvetuximab soravtansine represents an important advance for this biomarker-selected population."

The recommended dose of mirvetuximab soravtansine is 6 mg/kg—adjusted ideal body weight—administered intravenously once every three weeks until disease progression or unacceptable toxicity.

For More Information

Matulonis U, Lorusso D, Oaknin A, et al (2022). Efficacy and safety of mirvetuximab soravtansine in patients with platinum-resistant ovarian cancer with high folate receptor alpha expression: results from the SORAYA study. Gynecologic Oncology (SGO Annual Meeting Abstracts), 166(suppl_1):S50. Abstract LBA 4. DOI:10.1016/S0090-8258(22)01297-5

Clinicaltrials.gov (2022). A study of mirvetuximab soravtansine in platinum-resistant, advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high folate receptor-alpha expression. NLM identifier: NCT04296890.

Elahere® (mirvetuximab soravtansine-gynx) prescribing information (2022). ImmunoGen. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761310s000lbl.pdf

US Food & Drug Administration (2022). FDA grants accelerated approval to mirvetuximab soravtansine-gynx for FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or peritoneal cancer. Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-mirvetuximab-soravtansine-gynx-fra-positive-platinum-resistant

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