Clinical TrialApr 13, 2026, 06:11 AM
IDEAYA's Darovasertib Combo Achieves 6.9-Month PFS in mUM Trial
AI Summary
IDEAYA Biosciences and Servier announced positive clinical data from the Phase 2/3 OptimUM-02 trial for darovasertib in combination with crizotinib for first-line HLA-A*A2:01-negative metastatic uveal melanoma. The combination met its primary endpoint, demonstrating a statistically significant improvement in median progression-free survival (PFS) of 6.9 months compared to 3.1 months for investigator choice of therapy. Patients treated with the darovasertib combination saw a 58% reduction in the risk of disease progression, and the overall response rate was significantly higher at 37.1% versus 5.8%. These results will support an initial New Drug Application (NDA) submission.
Key Highlights
- Darovasertib combination achieved 6.9 months median PFS.
- Reduced disease progression risk by 58% (HR 0.42).
- Overall response rate (ORR) was 37.1%.
- ICT arm showed 3.1 months median PFS and 5.8% ORR.
- Results support initial NDA submission in US.