IDEAYA's Darovasertib Combination Shows Strong PFS Advantage in Uveal Melanoma Trial
Event summary
- IDEAYA's darovasertib combination achieved a median PFS of 6.9 months vs. 3.1 months for investigator's choice therapy in HLA*A2:01 negative metastatic uveal melanoma.
- The trial met its primary endpoint with a 58% reduction in risk of disease progression (HR: 0.42).
- NDA submission under RTOR program expected to complete in H2 2026.
- Overall survival data not yet mature but shows early favorable trend.
- Darovasertib combination demonstrated manageable safety profile with low discontinuation rates (2.5% for darovasertib, 10% for crizotinib).
The big picture
This trial represents a significant advancement in treating HLA*A2:01 negative metastatic uveal melanoma, a patient population with limited approved treatment options. The strong PFS results position darovasertib as a potential new standard of care, while the manageable safety profile suggests favorable adoption prospects. The RTOR program submission indicates IDEAYA's aggressive strategy to bring this therapy to market as quickly as possible.
What we're watching
- Regulatory Timeline
- Whether IDEAYA can complete its NDA filing and secure accelerated approval by year-end 2026.
- Survival Data Maturity
- The pace at which overall survival data will mature and potentially support full approval.
- Commercial Strategy
- How IDEAYA and Servier will position this combination therapy in the uveal melanoma treatment landscape.
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