IDEAYA Biosciences Announces Positive Interim Phase 2 Data for Darovasertib in the Neoadjuvant Setting of Primary Uveal Melanoma

Core Insights - IDEAYA Biosciences presented positive interim data from the Phase 2 OptimUM-09 trial of darovasertib for primary uveal melanoma, indicating potential advancements in treatment options where none currently exist [1][3] Group 1: Clinical Data and Efficacy - The trial showed that 76% (16 out of 21) of patients achieved a 20% ocular tumor shrinkage, which is a key response metric for the upcoming Phase 3 trial [4] - 48% (10 out of 21) of patients experienced a 20% reduction in simulated radiation dose to critical visual structures, with 86% (18 out of 21) achieving any reduction, correlating with improved visual outcomes [4] - 65% (13 out of 20) of patients noted visual improvement during treatment, with a median gain of 6 letters on the visual acuity score [4] - A prognostication tool indicated that 67% (14 out of 21) of patients had a reduction in the risk of developing legal blindness at 3 years post-treatment [4] Group 2: Safety Profile - Darovasertib demonstrated a manageable safety profile, with most treatment-related adverse events being Grade 1 and 2, and approximately 10% (4 out of 39) experiencing Grade 3 or higher events [4] - Common adverse events included diarrhea, nausea, fatigue, and maculo-papular rash, with four patients discontinuing treatment due to these events [4] Group 3: Future Developments - A Phase 3 registration-enabling trial, OptimUM-10, has been initiated in the second quarter of 2025 to further evaluate darovasertib in the neoadjuvant setting for primary uveal melanoma [3][4]