AbbVie has released the final data from its Phase 3 MIRASOL trial, demonstrating a notable survival benefit for ELAHERE (mirvetuximab soravtansine-gynx) in patients with folate receptor alpha-positive platinum-resistant ovarian cancer. The analysis, conducted after a median follow-up of 30.5 months, revealed that ELAHERE reduced the risk of death by 32% compared to chemotherapy.
Svetlana Kobina, MD, PhD, vice president of oncology medical affairs at AbbVie, stated: "Ovarian cancer can be devastating, and when cancer cells stop responding to chemotherapy patients may feel hopeless about their journey. The data presented today reinforce the importance of ELAHERE as a transformative therapy for patients with limited options."
In the United States, ovarian cancer remains the leading cause of death from gynecological cancers. Annually, around 20,000 women are diagnosed with this condition. Many develop resistance to platinum-based therapies and require alternative treatments like ELAHERE.
The MIRASOL study involved 453 participants with high-grade serous epithelial PROC who had been treated with up to three prior therapies. The findings showed that ELAHERE treatment led to superior efficacy compared to investigator's choice chemotherapy, with a median progression-free survival (PFS) of 5.59 months versus 3.98 months and an objective response rate of 41.9% versus 15.9%. Additionally, overall survival improved significantly for those receiving ELAHERE (median 16.85 months) compared to standard chemotherapy (median 13.34 months).
Toon Van Gorp, MD, PhD, professor of gynecologic oncology at the University of Leuven and an investigator in the study noted: "The final data showcase the significant improvement in overall survival benefit of treatment with ELAHERE compared to standard of care chemotherapy."
ELAHERE was granted full approval by the U.S. Food and Drug Administration in March 2024 and by the European Commission in November 2024.
Further details about the trial can be accessed on clinicaltrials.gov under NCT04209855.