FDA Grants Accelerated Approval to Mirvetuximab Soravtansine-gynx for Platinum-Resistant Ovarian Cancer Treatment

The FDA has granted accelerated approval to mirvetuximab soravtansine-gynx (Elahere; ImmunoGen Inc), an antibody-drug conjugate (ADC), for adult patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who were already treated with 1 of 3 systemic treatment regimens, including bevacizumab (Avastin).

The approval was based on data from the SORAYA trial, which has a primary endpoint of confirmed objective response rate (ORR) that was met by 31.7% of patients. The key secondary endpoint, defined as duration of response (DOR), was a median of 6.9 months.

"Platinum-resistant ovarian cancer is a notoriously challenging disease to treat. Given there have been no new therapies approved by FDA for this indication since 2014, [mirvetuximab soravtansine-gynx] accelerated approval is a tremendous advance in the ovarian cancer treatment paradigm,” said Anna Berkenblit, MD, senior vice president, and chief medical officer of ImmunoGen, in a press release.

Ovarian cancer, the most fatal gynecological cancer, is often diagnosed late-stage. Each year, 20,000 patients are diagnosed and 13,000 will die. Standard of care treatment is surgery and platinum-based chemotherapy. However, many patients develop platinum-resistant disease that reduces ORR/DOR and is difficult to treat.

The single-arm SORAYA trial enrolled 106 patients with platinum-resistant ovarian cancer, high levels of FRα expression, and who were previously treated with standard of care, single-agent chemotherapy. Mirvetuximab soravtansine-gynx was administered via intravenous solution once every 4 weeks at 6 mg/kg and adjusted to bodyweight.

“[Mirvetuximab soravtansine-gynx’s] impressive anti-tumor activity, durability of response, and overall tolerability observed in SORAYA demonstrate the benefit of this new therapeutic option, and I look forward to treating patients with [mirvetuximab soravtansine-gynx]," said SORAYA co-principal investigator Ursula Matulonis, MD, chief of the Division of Gynecologic Oncology at the Dana-Farber Cancer Institute, Professor of Medicine at the Harvard Medical School, in the press release.

The most common adverse events include vision impairment, fatigue, increased alanine aminotransferase, keratopathy, abdominal pain, decreased lymphocytes, peripheral neuropathy, diarrhea, decreased albumin, and constipation, among other symptoms. The safety of mirvetuximab soravtansine-gynx has been analyzed from a pool of 3 studies.

Currently, mirvetuximab soravtansine-gynx is being evaluated in the MIRASOL confirmatory randomized trial to receive full approval, with top-line data anticipated by early 2023.

The diagnostic tool VENTANA FOLR1 (FOLR1-2.1) RxDx Assay was also approved to identify patients who may be eligible for mirvetuximab soravtansine-gynx at the time of progression to platinum resistance.

“We are thrilled with today’s approval and extend our sincere thanks to the patients, families, caregivers, and investigators who helped make this achievement a reality and have supported the broader mirvetuximab development program,” Berkenblit said in the press release.

“With a highly experienced commercial and medical team in place, we are well prepared to support a successful launch and deliver [mirvetuximab soravtansine-gynx] rapidly to patients across the US," added Mark Enyedy, President, and Chief Executive Officer at ImmunoGen, in the press release.

Reference

ImmunoGen. ImmunoGen Announces FDA Accelerated Approval of ELAHERE™ (mirvetuximab soravtansine-gynx) for the Treatment of Platinum-Resistant Ovarian. News Release. November 15, 2022. Cancer https://www.businesswire.com/news/home/20221104005657/en