IDEAYA Biosciences Reports Positive Median Overall Survival Data from Phase 2 Trial of the Darovasertib and Crizotinib Combination in First-line Metastatic Uveal Melanoma at the 2025 Society for Melanoma Research Congress

Core Insights - IDEAYA Biosciences reported the first median overall survival results from their Phase 1/2 clinical trial (OptimUM-01) for darovasertib in combination with crizotinib for metastatic uveal melanoma, showing a median OS of 21.1 months [1][7] - The data will be presented at the 2025 Society for Melanoma Research Congress in Amsterdam [1] Clinical Trial Results - The trial included 44 first-line mUM patients with a median follow-up of 25 months, revealing a median progression-free survival (PFS) of 7.0 months [2] - The confirmed overall response rate (ORR) was 34% with a median duration of response (mDOR) of 9 months, and a disease control rate (DCR) of 90% [2][7] - The combination therapy demonstrated manageable tolerability, with common treatment-related adverse events including diarrhea, nausea, and fatigue [2] Comparison to Historical Data - The reported median OS of 21.1 months is significantly higher than the historical median OS of approximately 12 months for treatment-naïve patients with metastatic uveal melanoma [5][7] Future Developments - IDEAYA is conducting a registration-enabling Phase 2/3 trial (OptimUM-02) targeting HLA*A2:01-negative mUM, with median PFS data expected by the end of 2025 to early 2026 [5] - The company aims to support a potential U.S. accelerated approval filing based on the trial results [5]