IDEAYA Biosciences and Servier reported Monday on three darovasertib studies, including a randomized trial that found longer progression-free survival with the combination than with doctors’ selected treatment.
In OptimUM-09, patients received darovasertib before surgery or radiation for tumors in the eye. In results based on 116 patients as of Feb. 23, 2026, 67 patients, or 57.8%, had tumor shrinkage of at least 20%. IDEAYA said 57% of patients initially recommended for eye removal kept the eye. In a separate radiation group, 66% had a reduction in the planned dose to critical eye structures. These figures do not show whether patients retain vision over time.
The OptimUM-09 poster scheduled for the European Society for Medical Oncology (ESMO) Congress will include 119 patients as of June 15, 2026. The company has not provided updated figures for the outcomes reported in the earlier analysis.
OptimUM-01 tested darovasertib plus crizotinib in 101 patients with the HLA-A*02:01 marker and did not have a comparison group. Among 13 patients who had not received previous systemic treatment, median progression-free survival was 7.4 months and median overall survival was 27.1 months; four of 11 patients evaluable for response responded. The study’s median follow-up was 10.4 months as of March 23, 2026. Among 15 patients whose only previous systemic treatment was tebentafusp, five of 14 evaluable patients responded, and median progression-free survival was 5.7 months. Treatment-related adverse events led nine of the 101 patients to stop treatment.
The U.S. Food and Drug Administration (FDA) approved tebentafusp in 2022 for adults with HLA-A*02:01-positive uveal melanoma that is unresectable or has spread. The marker therefore distinguishes the OptimUM-01 group from patients in OptimUM-02, who lacked it.
OptimUM-02 randomly assigned 313 previously untreated patients without HLA-A*02:01 to the combination or investigators’ chosen therapy. Median progression-free survival was 6.9 months with darovasertib plus crizotinib and 3.1 months in the comparison group. Response rates were 37.1% and 5.8%, respectively. IDEAYA had reported these main results in June; the Oct. 19 update adds subgroup analyses. The primary analysis did not yet provide mature overall-survival data.
Darovasertib remains investigational and is not approved by the FDA or another regulator, IDEAYA said. The company expects to complete a U.S. new drug application for the combination in the second half of 2026. IDEAYA retains U.S. rights to the drug, while Servier holds rights elsewhere. IDEAYA’s securities filing says it received $210 million upfront and may receive up to $320 million in milestones; the companies share development costs, and Servier handles regulatory and commercial work outside the United States.
The three posters are scheduled for Saturday, Oct. 24, from 6 to 6:45 a.m. ET at the ESMO Congress in Madrid.
