Ideaya Biosciences reports overall survival data from darovasertib trial

Ideaya Biosciences (IDYA) announced the first reported median overall survival results from their Phase 1/2 clinical trial evaluating darovasertib, the company’s investigational oral protein kinase C inhibitor, in combination with Pfizer’s (PFE) crizotinib1, a c-MET inhibitor, as a first-line treatment for patients with metastatic uveal melanoma. The data will be presented on Sunday, October 26 at the 2025 Society for Melanoma Research Congress taking place in Amsterdam, Netherlands. The presentation at SMR will include data from 44 first-line mUM patients, including both HLA*A2:01-negative and HLA*A2:01-positive patients, in the single-arm Phase 1/2 OptimUM-01 trial with a median follow-up time of 25 months as of a cut-off date of May 28. Across all 44 patients treated with the darovasertib and crizotinib combination, a median OS of 21.1 months and a median PFS of 7 months was observed. In 41 efficacy-evaluable patients, the confirmed ORR by RECIST 1.1 was 34% with a 9 month mDOR. A DCR of 90% was also observed, with 85% of patients achieving ‘any reduction’ in target lesions. The combination continued to have manageable tolerability, with the most common treatment-related adverse events of diarrhea, nausea, edema, vomiting, dermatitis, hypoalbuminemia, and fatigue. No Grade 3 or greater TRAEs greater than 5% were observed. The proportion of patients enrolled in the OptimUM-01 study that had baseline ECOG performance status scores of 0 and 1 was 61% and 39%, respectively. The proportion of patients with ECOG PS 1 in the OptimUM-01 study is approximately two times higher than an earlier published registrational study in mUM.