Clinical TrialJun 1, 2026, 04:05 PM
IDEAYA Biosciences: Darovasertib Combo Shows 58% PFS Improvement in Uveal Melanoma Trial
AI Summary
IDEAYA Biosciences, Inc. presented complete data from its Phase 2/3 OptimUM-02 trial at the ASCO Annual Meeting, showcasing positive results for the darovasertib combination in first-line metastatic uveal melanoma. The trial met its primary endpoint, demonstrating a statistically significant improvement in median Progression-Free Survival (PFS) and Objective Response Rate (ORR) compared to the Investigator's Choice of Therapy (ICT) arm. While overall survival data is still maturing, an early trend suggests improvement. The combination therapy was generally well-tolerated.
Key Highlights
- IDEAYA Biosciences and Servier presented complete data from the Phase 2/3 OptimUM-02 trial of darovasertib combination in first-line metastatic uveal melanoma at ASCO.
- The darovasertib combination demonstrated a statistically significant improvement in median Progression-Free Survival (PFS) of 6.9 months vs. 3.1 months in the Investigator's Choice of Therapy (ICT) arm by blinded independent central review (BICR) (HR: 0.42; p-value: <0.0001).
- Objective Response Rate (ORR) was 37.1% (BICR) for the darovasertib combination vs. 5.8% for ICT (p-value: <0.0001).
- Disease Control Rate (DCR) was 73.3% (BICR) for the darovasertib combination vs. 31.1% for ICT.
- The darovasertib combination was generally well-tolerated with a manageable safety profile.
- Grade 3/4 treatment-related adverse events (TRAEs) occurred in 40.6% of patients in the darovasertib combination arm compared to 37.0% in the ICT arm.
- Overall survival (OS) data was immature, but an early trend in OS improvement was observed in the darovasertib combination arm.
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