IDEAYA's darovasertib combo meets primary endpoint in Phase 2/3 OptimUM-02 trial for metastatic uveal melanoma

IDEAYA Biosciences, Inc.

Darovasertib + crizotinib achieved median PFS 6.9 months vs 3.1 months for investigator's choice (HR=0.42, p<0.0001) by BICR, reducing risk of progression by 58%.
Objective response rate 37.1% (combo) vs 5.8% (control) by BICR; disease control rate 73.3% vs 31.1%.
Grade 3/4 TRAEs 40.6% vs 37.0%; treatment-related discontinuations low (darovasertib 2.5%, crizotinib 10.0% vs ICT 19.0%).
FDA agreed to review darovasertib NDA under Real-Time Oncology Review; submission expected in H2 2026.
Overall survival data immature but early trend favoring combo; future analysis will support full approval.

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