MIRASOL trial shows benefits for certain ovarian cancer patients

AbbVie has announced the final analysis of the confirmatory Phase 3 MIRASOL trial evaluating the efficacy and safety of ELAHERE (mirvetuximab soravtansine-gynx) in women with folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer (PROC) compared to chemotherapy.

The results showed that at 30.5 months median follow-up, treatment with ELAHERE continued to show significant improvements in progression-free survival (PFS) and overall survival (OS) compared to investigator’s choice (IC) chemotherapy.

Ovarian cancer patients often present with late-stage disease and are historically first treated with platinum-based chemotherapy, which they may become resistant to and require another therapy, such as ELAHERE.

“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,” said Svetlana Kobina, vice president, oncology medical affairs, AbbVie.

“We remain steadfast in our commitment to bring forward innovative therapies that improve the lives of patients with difficult-to-treat cancers.”

The Phase 3 MIRASOL study included 453 patients with high-grade serous epithelial PROC whose tumours express high levels of FRα and had been treated with up to three prior therapies.

Key findings from the 30.5-month median follow-up include that ELAHERE treatment achieved superior efficacy versus IC chemotherapy, representing a 37 per cent reduction in the risk of tumour progression or death and a higher objective response rate of 41.9 per cent versus 15.9 per cent.

It also demonstrated clinically meaningful overall survival for patients receiving ELAHERE compared to IC chemotherapy, representing a 32 per cent reduction in the risk of death.

“The final data showcase the significant improvement in overall survival benefit of treatment with ELAHERE compared to standard of care chemotherapy,” said investigator and presenter, Toon Van Gorp, professor of Gynecologic Oncology, University of Leuven.

“The significant improvements in survival, along with the well-characterized safety profile, reinforce ELAHERE as an emerging standard of care for difficult-to-treat ovarian cancer and warrants further study of this medicine in earlier treatment settings.”