AbbVie has revealed the final results of its Phase 3 MIRASOL trial, showing the efficacy and safety of Elahere (mirvetuximab soravtansine-gynx) in patients with folate receptor alpha-positive platinum-resistant ovarian cancer (PROC) when compared to chemotherapy.
The study, conducted over a median follow-up period of 30.5 months, highlighted notable improvements in both progression-free survival (PFS) and overall survival (OS) for those treated with Elahere.
The MIRASOL trial involved 453 participants, all diagnosed with high-grade serous epithelial PROC and exhibiting high levels of folate receptor alpha after up to three prior treatments.
Elahere demonstrated superior efficacy over investigator’s choice chemotherapy, achieving a median PFS of 5.59 months in contrast to the 3.98 months observed with chemotherapy. This indicates a 37% reduction in the risk of tumour progression or death, with an objective response rate of 41.9% compared to 15.9%.
Furthermore, the overall survival of patients receiving Elahere reached a median of 16.85 months, significantly surpassing the 13.34-month median for those undergoing chemotherapy. This marks a 32% reduction in the risk of death for Elahere recipients.
AbbVie oncology medical affairs vice president Svetlana Kobina said: “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.
“We remain steadfast in our commitment to bring forward innovative therapies that improve the lives of patients with difficult-to-treat cancers.”
Safety analysis revealed that treatment-emergent adverse events (TEAEs), such as blurred vision and fatigue, occurred less frequently with Elahere than with chemotherapy. This also resulted in fewer severe adverse events and discontinuations due to adverse effects.
The trial’s key endpoints included PFS by investigator assessment, objective response rate, and OS. The study population was stratified based on prior lines of therapy and the type of chemotherapy received, with paclitaxel being the most common choice.
Elahere, an antibody-drug conjugate targeting folate receptor alpha, received full approval from the US Food and Drug Administration (FDA) in March 2024 and European Commission (EC) approval in November 2024. Applications for marketing authorisation are currently under assessment in various countries.
AbbVie added the drug to its portfolio through the $10.1bn acquisition of ImmunoGen in 2023.
