Zinger Key Points
- Elahere shows a 37% lower risk of tumor progression or death vs. chemotherapy, with a median PFS of 5.59 months vs. 3.98 months.
- Patients on Elahere have a median overall survival of 16.85 months, a 32% lower risk of death vs. chemotherapy's 13.34 months.
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AbbVie Inc ABBV released on Saturday the final analysis of the confirmatory Phase 3 MIRASOL trial of Elahere (mirvetuximab soravtansine-gynx) in women with folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer (PROC) compared to chemotherapy.
The U.S. Food and Drug Administration granted full approval to Elahere in March 2024, and the European Commission approved the drug in November 2024.
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.
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The Phase 3 MIRASOL study included 453 patients with high-grade serous epithelial PROC whose tumors express high levels of FRα and had been treated with up to three prior therapies:
- Elahere treatment achieved superior efficacy versus IC chemotherapy, with a median PFS of 5.59 months versus 3.98 months, representing a 37% reduction in the risk of tumor progression or death and a higher objective response rate of 41.9% versus 15.9%.
- Superior and clinically meaningful overall survival for patients receiving Elahere (median 16.85 months) compared to IC chemotherapy (median 13.34 months), representing a 32% reduction in the risk of death.
- Other endpoints included safety and duration of response (DOR), which were consistent with the primary data analysis at 13.1-months median follow-up.
ABBV Price Action: AbbVie stock is up 1.63% at $212.23 at publication Monday.
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