The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization for mirvetuximab soravtansine (ELAHERE®) for adult patients with folate receptor alpha (FRα)-positive, platinum-resistant, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior treatment regimens.
This decision offers hope for patients with ovarian cancer who often face late-stage diagnoses and develop resistance to platinum-based chemotherapies, requiring alternative treatments. The European Commission is expected to make a final decision on the authorization later this year.
Supporting Evidence from the MIRASOL Trial
The CHMP's positive opinion is backed by data from the Phase 3 MIRASOL trial, a global, open-label, randomized, controlled study involving 453 patients. The trial compared mirvetuximab soravtansine to investigator's choice of single-agent chemotherapy (weekly paclitaxel, pegylated liposomal doxorubicin, or topotecan) in patients with platinum-resistant, high-grade serous ovarian cancer expressing high levels of FRα (≥75% of cells with ≥2+ staining intensity).
The primary endpoint of the trial was investigator-assessed progression-free survival (PFS). Key secondary endpoints included objective response rate (ORR) and overall survival (OS). Results shared in June 2023 indicated a 35% reduction in the risk of disease progression or death with mirvetuximab soravtansine compared to chemotherapy.
Addressing Unmet Needs in Ovarian Cancer Treatment
Ovarian cancer is a leading cause of death from gynecological cancers, with over 320,000 women diagnosed worldwide in 2022. This number is projected to rise to nearly half a million by 2050, marking a 55% increase. Most patients are diagnosed at a late stage and undergo surgery followed by platinum-based chemotherapy. However, many develop platinum resistance, necessitating alternative therapies with improved efficacy and tolerability.
Mechanism of Action and Prior Approvals
Mirvetuximab soravtansine is a first-in-class antibody-drug conjugate (ADC) comprising a folate receptor-alpha binding antibody, a cleavable linker, and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill targeted cancer cells. The drug received full FDA approval in the United States in March 2024 for the same indication. Marketing authorization submissions are currently under review in multiple other countries.
Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie, stated, "Following many years of development by the ImmunoGen team that is now part of AbbVie, we are hopeful to make mirvetuximab soravtansine available to eligible patients with ovarian cancer in the European Union. This positive opinion recognizes the unmet need for certain patients with platinum-resistant ovarian cancer."
