EU Approves AbbVie's ELAHERE® for Platinum-Resistant Ovarian Cancer

AbbVie, a global biopharmaceutical company, has announced that the European Commission has granted marketing authorization for ELAHERE® (mirvetuximab soravtansine), a novel therapy for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. This treatment marks the first approved folate receptor-alpha directed antibody drug conjugate (ADC) in the European Union and surrounding countries, including Iceland, Liechtenstein, Norway, and Northern Ireland.

ELAHERE is a significant breakthrough as it is the first treatment to demonstrate an overall survival benefit for patients with platinum-resistant ovarian cancer in a Phase 3 clinical trial compared to chemotherapy. The approval gives oncologists a much-needed effective and targeted option after a decade without new treatments for this type of cancer in the EU.

Ovarian cancer is a leading cause of death among gynecological cancers, with most patients being diagnosed in the late stages and usually undergoing surgery followed by platinum-based chemotherapy. However, many patients develop resistance to platinum-based treatments, leading to limited options that often come with adverse effects impacting their quality of life.

Clara Mackay, CEO of the World Ovarian Cancer Coalition, emphasizes the devastating impact ovarian cancer has on women, affecting their family lives, careers, and societal contributions. In Europe, ovarian cancer is significantly more deadly than breast cancer, making the introduction of innovative treatments like ELAHERE crucial for improving survival rates and quality of life for patients.

In about one-third of ovarian cancer cases, the folate receptor alpha (FRα) biomarker is highly expressed, allowing these patients to be identified using Roche's VENTANA FOLR1 (FOLR1-2.1) RxDx Assay at diagnosis or upon resistance to platinum-based therapy. AbbVie's collaboration with Roche Diagnostics has facilitated the development of this companion diagnostic test, identifying patients eligible for ELAHERE.

Dr. Roopal Thakkar, AbbVie's executive vice president, research and development, and chief scientific officer, highlights that ELAHERE provides a clinically meaningful option for patients facing the return of ovarian cancer and the development of platinum resistance.

The marketing authorization for ELAHERE is supported by data from the MIRASOL Phase 3 open-label, randomized, controlled trial. The trial included patients aged 18 and older with disease progression after one to three lines of previous therapy, with high levels of FRα expression. The primary endpoint of the trial was progression-free survival (PFS), with secondary endpoints including objective response rate (ORR) and overall survival (OS).

Results presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting revealed a 35% reduction in the risk of tumor progression or death in patients treated with ELAHERE compared to chemotherapy. Additionally, ELAHERE demonstrated a 33% reduction in the risk of death compared to chemotherapy.

The most common adverse reactions included blurred vision, nausea, diarrhea, fatigue, abdominal pain, keratopathy, dry eye, constipation, vomiting, decreased appetite, peripheral neuropathy, headache, asthenia, increased aspartate aminotransferase, and arthralgia, with pneumonitis being the most commonly reported serious adverse reaction.

ELAHERE's approval and the accompanying diagnostic tool represent a significant advancement in the treatment of platinum-resistant ovarian cancer, offering new hope and improved outcomes for patients facing this challenging condition.