AbbVie Inc ABBV launched on Saturday the ultimate evaluation of the confirmatory Part 3 MIRASOL trial of Elahere (mirvetuximab soravtansine-gynx) in girls with folate receptor alpha (FRα)-positive platinum-resistant ovarian most cancers (PROC) in comparison with chemotherapy.
The U.S. Meals and Drug Administration granted full approval to Elahere in March 2024, and the European Fee permitted the drug in November 2024.
At 30.5 months median follow-up, remedy with Elahere continued to point out important enhancements in progression-free survival (PFS) and general survival (OS) in comparison with investigator’s alternative (IC) chemotherapy.
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The Part 3 MIRASOL examine included 453 sufferers with high-grade serous epithelial PROC whose tumors specific excessive ranges of FRα and had been handled with as much as three prior therapies:
- Elahere remedy achieved superior efficacy versus IC chemotherapy, with a median PFS of 5.59 months versus 3.98 months, representing a 37% discount within the threat of tumor development or demise and a better goal response fee of 41.9% versus 15.9%.
- Superior and clinically significant general survival for sufferers receiving Elahere (median 16.85 months) in comparison with IC chemotherapy (median 13.34 months), representing a 32% discount within the threat of demise.
- Different endpoints included security and period of response (DOR), which had been in keeping with the first knowledge evaluation at 13.1-months median follow-up.
ABBV Value Motion: AbbVie inventory is up 1.63% at $212.23 at publication Monday.
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Momentum81.05
Progress80.22
High quality60.20
Worth12.57
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