ELAHERE® (mirvetuximab soravtansine-gynx) Shows Consistent Survival Benefit in Long-Term Analysis for Certain Ovarian Cancer Patients

Core Insights - AbbVie announced significant findings from the Phase 3 MIRASOL trial, demonstrating that ELAHERE (mirvetuximab soravtansine-gynx) significantly improves progression-free survival (PFS) and overall survival (OS) in women with folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer compared to standard chemotherapy [1][5][6] Group 1: Efficacy and Safety - ELAHERE treatment resulted in a median PFS of 5.59 months versus 3.98 months for investigator's choice (IC) chemotherapy, indicating a 37% reduction in the risk of tumor progression or death [6] - The median OS for patients receiving ELAHERE was 16.85 months compared to 13.34 months for IC chemotherapy, representing a 32% reduction in the risk of death [6] - The most common treatment-emergent adverse events (TEAEs) in the ELAHERE group included blurred vision, keratopathy, and abdominal pain, but overall rates of grade ≥3 TEAEs were lower compared to IC chemotherapy [2][6] Group 2: Trial Details - The MIRASOL trial enrolled 453 patients with high-grade serous epithelial PROC, all of whom had received up to three prior therapies [7] - Key endpoints of the trial included PFS, objective response rate (ORR), and OS, with a focus on patients whose tumors express high levels of FRα [7] Group 3: Regulatory Status - ELAHERE received full approval from the U.S. Food and Drug Administration in March 2024 and was approved by the European Commission in November 2024, with additional marketing applications under review in multiple countries [4]