IDEAYA Biosciences(US:IDYA) Prnewswireยท2025-10-20 10:30Core Insights - IDEAYA Biosciences presented positive clinical data from the Phase 2 OptimUM-09 trial of neoadjuvant darovasertib for primary uveal melanoma, highlighting its potential as the first systemic therapy for this condition [1][2][10] Clinical Trial Data - The trial involved 95 primary uveal melanoma patients, with 94 evaluable for efficacy as of June 13, 2025 [2] - 83% of patients demonstrated ocular tumor shrinkage, with 54% achieving at least 20% tumor shrinkage [5][10] - Among patients recommended for enucleation, the eye preservation rate was 57%, increasing to 95% for those achieving 20% tumor shrinkage [5][10] - 70% of plaque brachytherapy eligible patients showed a reduction in predicted radiation dose, leading to a 65% lower risk of vision loss at three years post-treatment [5][10] Visual Acuity Improvement - Approximately 55% of enucleation eligible patients and 61% of plaque brachytherapy eligible patients showed improvement in visual acuity scores during treatment, with mean gains of 17 and 10 letters, respectively [5][10] Safety Profile - Darovasertib was generally well tolerated, with manageable adverse events; 16.8% of patients experienced grade 3 or higher treatment-related adverse events [10] Future Developments - IDEAYA is conducting a Phase 3 trial (OptimUM-10) of darovasertib and plans to report topline median progression-free survival data from another trial (OptimUM-02) by the end of 2025 to Q1 2026 [7][10]