CHMP Recommends AbbVie's Mirvetuximab for Ovarian Cancer Treatment

NORTH CHICAGO, Ill., Sept. 20, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) has revealed that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a favorable opinion advocating for the marketing authorization of mirvetuximab soravtansine (ELAHERE®). This recommendation is for adult patients with folate receptor alpha (FRα)-positive, platinum-resistant, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have undergone one to three prior treatment regimens. 

Ovarian cancer patients are frequently diagnosed at an advanced stage and typically undergo surgery followed by platinum-based chemotherapy. However, over time, many patients develop resistance to platinum-based treatments and consequently require alternative therapies. The CHMP's endorsement is founded on the outcomes of the Phase 3 MIRASOL clinical trial. The decision by the European Commission regarding this indication for mirvetuximab soravtansine is expected later this year.

Dr. Roopal Thakkar, executive vice president, research and development, and chief scientific officer at AbbVie, stated, "Following years of development by the ImmunoGen team, now part of AbbVie, we aim to make mirvetuximab soravtansine accessible to eligible ovarian cancer patients in the EU. This positive opinion highlights the unmet need among patients with platinum-resistant ovarian cancer."

In the United States, ELAHERE® (mirvetuximab soravtansine-gynx) received full FDA approval in March 2024. Submissions for its marketing authorization are currently under evaluation in various other countries.

The Phase 3 MIRASOL trial is a global, open-label, randomized, controlled study that involved 453 patients. The primary goal was to compare the efficacy and safety of mirvetuximab soravtansine against the investigator’s choice of single-agent chemotherapy options such as weekly paclitaxel, pegylated liposomal doxorubicin, or topotecan. Participants had previously received one to three lines of treatment. The primary endpoint analyzed was progression-free survival (PFS), with key secondary endpoints including the objective response rate (ORR) and overall survival (OS).

Previously disclosed in June 2023, the study’s results indicated a significant benefit for patients.
Ovarian cancer ranks among the leading causes of death from gynecological cancers. As reported by the World Ovarian Cancer Coalition, over 320,000 women globally were diagnosed with ovarian cancer in 2022, and this number is projected to rise to nearly half a million by 2050, marking a 55 percent increase. Most patients present with late-stage disease, typically undergoing surgery followed by platinum-based chemotherapy. However, the majority ultimately develop resistance to platinum treatments, posing a challenging scenario to manage.

Mirvetuximab soravtansine is a pioneering antibody-drug conjugate (ADC) that consists of a folate receptor-alpha binding antibody, a cleavable linker, and the maytansinoid payload DM4, a potent tubulin inhibitor designed to target and destroy cancer cells. It is not currently approved in the EU.

ELAHERE® (mirvetuximab soravtansine-gynx) is intended for adult patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have previously undergone one to three systemic treatment regimens. Selection for treatment is based on an FDA-approved test.

AbbVie is dedicated to transforming cancer care standards for patients with challenging-to-treat cancers. The company is advancing a diverse pipeline of investigational therapies across various cancer types, covering blood cancers and solid tumors. AbbVie focuses on creating targeted medicines that either inhibit cancer cell reproduction or promote their destruction. This objective is achieved through several targeted treatment modalities, including Antibody Drug Conjugates (ADCs), Immuno-Oncology, bi-specific antibodies, and CAR-T platforms. 

AbbVie's extensive oncology portfolio includes approved and experimental treatments for an array of blood and solid tumors. They are currently evaluating over 20 investigational medicines in multiple clinical trials addressing some of the world's most prevalent and debilitating cancers. Committed to impacting lives significantly, AbbVie works to ensure patients have access to their cancer medicines.

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