The OptimUM-02 trial enrolled 313 first-line HLA-A*02:01-negative metastatic uveal melanoma patients randomized 2:1 to darovasertib plus crizotinib (210 patients) or investigator choice therapy (103 patients). The darovasertib combination reduced progression risk by 58% versus ICT (HR 0.42; 95% CI 0.30–0.59; p<0.0001) and extended median PFS to 6.9 months versus 3.1 months, achieving an ORR of 37.1% versus 5.8% and five complete responses.

The combination regimen was generally well tolerated, with the most common Grade 3+ treatment-emergent adverse events including diarrhea, syncope and hypotension. Serious treatment-related adverse events remained in the single-digit percent range, consistent with known profiles of each agent, and no new safety signals emerged.

Based on these positive topline data, IDEAYA plans to submit a New Drug Application to the U.S. FDA in the second half of 2026 under the accelerated approval pathway, using median PFS as the primary endpoint support. The company targets initial U.S. labeling for first-line HLA-A*02:01-negative metastatic uveal melanoma.

Full data from the OptimUM-02 trial will be presented at a major medical conference in 2026, and IDEAYA will host a webcast today at 8:00 AM ET to discuss detailed results and development roadmap. Management and key opinion leaders will address questions on efficacy, safety and regulatory strategy.