AbbVie (NYSE: ABBV) today announced the European Commission (EC) granted marketing authorization for ELAHERE® (mirvetuximab soravtansine) 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 who have received one to three prior systemic treatment regimens. ELAHERE is the first and only folate receptor alpha (FRɑ)-directed antibody drug conjugate (ADC) medicine approved in the European Union (EU), as well as Iceland, Liechtenstein, Norway, and Northern Ireland.
“It’s been 10 years since a new treatment for platinum-resistant ovarian cancer was approved in the EU, and now oncologists have an effective, new, targeted treatment option for these patients,” said Toon Van Gorp, Professor of Gynaecological Oncology at the University of Leuven.
Ovarian cancer is one of the leading causes of death from gynecological cancers worldwide.i Most patients present with late-stage disease and will typically undergo surgery followed by platinum-based chemotherapy. Unfortunately, most patients eventually develop platinum-resistant disease.ii Historically, treatment options for patients with platinum-resistant ovarian cancer (PROC) have been limited, and those available often result in adverse events which can negatively impact quality of life.iii
“Ovarian cancer can be devastating, taking women away from precious moments with their family, disrupting careers and the many other important contributions that women make to society,” said Clara Mackay, CEO, World Ovarian Cancer Coalition. “In Europe, ovarian cancer is three times more deadly than breast cancer, and having new innovative options allows us to work toward a world where everyone living with ovarian cancer has the best chance of survival and the best quality of life possible, no matter where they live.”
In approximately one third of people living with ovarian cancer, the folate-receptor alpha (FRα) biomarker is highly expressediv (≥75% of tumor cells with ≥2+ membrane staining intensity). To determine biomarker status, patients can be tested with Roche’s VENTANA® FOLR1 (FOLR1-2.1) RxDx Assay at diagnosis or at the first sign of resistance to platinum-based chemotherapy. AbbVie collaborated with Roche Diagnostics on the newly approved immunohistochemistry (IHC) companion diagnostic test to identify patients who may be eligible for ELAHERE.
“The approval of ELAHERE by the European Commission provides a much needed clinically meaningful option for patients who receive the heartbreaking news their ovarian cancer has returned, fearing what’s next in their treatment journey after they’ve developed platinum-resistance,” said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie.
The marketing authorization of ELAHERE is supported by data from MIRASOL: a global, Phase 3 open-label, randomized, controlled trial.
- Trial participants were 18 years of age or older with disease that had progressed while on or after one to three lines of previous therapy. Patient tumors had to express high levels of FRɑ (≥75% of tumor cells with ≥2+ membrane intensity), assessed using the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay. The primary endpoint was investigator-assessed progression-free survival (PFS). Key secondary endpoints included objective response rate (ORR) and overall survival (OS).
- Results presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting demonstrated a 35% reduction in the risk of tumor progression or death in patients treated in the ELAHERE arm compared with the investigator’s choice (IC) chemotherapy arm, which represented an improvement in PFS [HR 0.65 (95% CI: 0.52, 0.81; p<0.0001)].
- ELAHERE also demonstrated improvement in OS compared with IC chemotherapy, representing a 33% reduction in the risk of death in the ELAHERE arm in comparison to the IC chemotherapy arm [HR 0.67 (95% CI: 0.50, 0.89; p=0.0046)].
- The most common adverse reactions with ELAHERE were blurred vision, nausea, diarrhea, fatigue, abdominal pain, keratopathy, dry eye, constipation, vomiting, decreased appetite, peripheral neuropathy, headache, asthenia, increased aspartate aminotransferase and arthralgia. The most commonly reported serious adverse reaction was pneumonitis.
- Data from the Phase 3 MIRASOL Trial were also published in the New England Journal of Medicine (NEJM).