Results from the Phase 3 MIRASOL Trial
The phase 3 MIRASOL trial, presented at the 2023 ASCO Annual Meeting, demonstrated the efficacy of mirvetuximab soravtansine in improving overall survival for patients with platinum-resistant ovarian cancer expressing high folate receptor-alpha. This groundbreaking study positions mirvetuximab as a potential new standard of care in this patient population.
- Mirvetuximab soravtansine is the first novel treatment to show a survival benefit in a phase 3 trial for platinum-resistant ovarian cancer.
- The MIRASOL trial demonstrated a 35% reduction in the risk of progression or death with the use of mirvetuximab compared to investigator’s choice chemotherapy (P-value < 0.0001).
- The overall response rate was 42% for mirvetuximab, significantly higher than the 16% for investigator’s choice chemotherapy (P-value < 0.0001).
- Median overall survival with mirvetuximab was 16.5 months, compared to 12.75 months in the control arm, representing a 33% reduction in the hazard of death (P-value = 0.0046).
- The safety profile of mirvetuximab was consistent with prior studies, with fewer grade three treatment emergent adverse events and fewer discontinuations due to treatment emergent adverse events compared to investigator’s choice chemotherapy.
- The most common side effects associated with mirvetuximab were low grade ocular and gastrointestinal events.
- The MIRASOL trial data positions mirvetuximab as a potential new standard of care for patients with folate receptor alpha-high platinum-resistant ovarian cancer, demonstrating significant improvements in progression-free survival, overall response rate, and overall survival.