IDEAYA Biosciences and Servier's Topline Data From Phase 2/3 OptimUM-02 Trial Of Darovasertib Plus Crizotinib In HLA-A*02:01-Negative Metastatic Uveal Melanoma Met Primary Endpoint
Trial met the primary endpoint showing statistically significant improvement in median PFS by BICR, with 6.9 months for the darovasertib combination versus 3.1 months for ICT (HR: 0.42; 95% CI: 0.30, 0.59; p-value: <0.0001)
Secondary endpoint of ORR by BICR was 37.1% for the darovasertib combination versus 5.8% for ICT (p-value: <0.0001), including 5 complete responses in the darovasertib combination arm
Darovasertib combination showed an early trend in improvement for OS versus ICT
Well-tolerated, with manageable safety profile consistent with previously reported AEs
NDA submission planned for H2'26 to support U.S. accelerated approval filing. Full data from OptimUM-02 to be presented at major medical conference in 2026
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