Ideaya Biosciences and Servier Announce Positive Topline Results from Phase 2/3 Registrational Trial of Darovasertib in Combination with Crizotinib in First-Line Hla-A*02: 01-Negative Metastatic Uveal Melanoma

Published: 2026-04-13 12:51:01 ET IDYA

Published on 04/13/2026 at 12:51 pm EDT

Ideaya Biosciences, Inc. and Servier announced positive topline results from their Phase 2/3 registrational trial, OptimUM-02, evaluating darovasertib in combination with crizotinib (darovasertib combination) in patients with first-line HLA-A*A2:01-negative metastatic uveal melanoma (mUM). The darovasertib combination met the trial's primary endpoint of a statistically significant improvement in median progression-free survival (PFS) relative to the investigator choice of therapy (ICT) arm as assessed by blinded independent central review (BICR). The secondary endpoints in the study include overall response rate (ORR) and duration of response (DOR).

OptimUM-02 is the first randomized study to demonstrate a statistically significant and clinically meaningful benefit in PFS in the clinical setting of first-line HLA-A*02:01-negative metastatic uveal melanoma. OptimUM-02 is a global, randomized Phase 2/3 trial in 1L HLA-A*A2:01-negative MUM evaluating darovasertib combination arm of 210 patients versus the ICT arm reflective of real-world clinical practice that consists of 103 patients. The ICT arm was composed of 76% (n=78) ipilimumab plus nivolumab (anti-CTLA-4/PD-1) and 24% (n=25) pembrolizumab (anti-PD-1).

The primary endpoint is median PFS as assessed by BICR, which will be used to support an initial NDA submission in the United States. Topline results were from a total of 313 patients enrolled in the Phase 2b/3 portion of the trial as of the cut-off date of January 23, 2026. The PFS analysis was based on a total of 159 events.

Patients treated with the darovasertib combination reduced their risk of disease progression as assessed by BICR by 58% (Hazard Ratio of 0.42; 95% CI: 0.30, 0.59; p-value: 10,000 patients globally (including North America, Europe and Australia) and >3,000 patients in the United States, with approximately 50% of patients progressing to metastatic disease (mUM). We estimate the majority (50-70%) of mUM patients are of the HLA-A*02:01-negative serotype. Currently, there are no FDA-approved systemic therapies for primary UM and no FDA-approved therapies for patients with HLA-A*02:01-negative mUM.