IDEAYA Biosciences Completes Targeted Full Enrollment in Randomized Pivotal Phase 2/3 Trial (OptimUM-02) of Darovasertib in Combination with Crizotinib in First-line HLA*A2-Negative Metastatic Uveal Melanoma

• Targeted enrollment of 435 patients to enable potential full approval filing has been completed in OptimUM-02 trial
• Topline data, including median PFS, are expected in 1Q 2026 to support a potential accelerated approval filing in the United States

Excerpt from the Press Release:

SOUTH SAN FRANCISCO, Calif., Dec. 11, 2025 /PRNewswire/ — IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a leading precision medicine oncology company, today announced it has completed its targeted full enrollment of 435 patients in the registration-enabling Phase 2/3 trial (OptimUM-02) evaluating darovasertib, the company’s investigational oral protein kinase C (PKC) inhibitor, in combination with Pfizer’s crizotinib, an oral c-MET inhibitor, in first line (1L) HLA*A2-negative metastatic uveal melanoma (mUM).  IDEAYA expects to report median progression-free survival (PFS) data from this trial in the first quarter 2026 to support a potential accelerated approval filing in the United States.  Median overall survival (mOS) data from OptimUM-02, once available, will be used to support a potential full approval filing.  Metastatic uveal melanoma is a rare, aggressive form of ocular cancer with limited treatment options and historically poor survival outcomes.

“We are very pleased to announce that we have achieved the target enrollment to enable potential full approval filing in our Phase 2/3 registration-enabling trial of darovasertib in combination with crizotinib in first-line HLA*A2-negative metastatic uveal melanoma. This milestone reflects both the clear unmet need in metastatic uveal melanoma, as well as the strong clinical interest in our darovasertib program. Moreover, the promising overall survival data and broader clinical efficacy demonstrated in the recently reported median overall survival results from the Phase 1/2 clinical trial (OptimUM-01) of this combination in metastatic uveal melanoma are indicative of the clinical potential of darovasertib to meaningfully impact patients with this devastating disease.  With target full enrollment now complete, we look forward to the availability of median PFS data we project from OptimUM-02 in the first quarter of next year, and, if approved, making darovasertib in combination with crizotinib available to patients with HLA*A2-negative metastatic uveal melanoma as a first-line treatment as expeditiously as possible,” said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.

OptimUM-02 is a multi-arm, multi-stage, open-label Phase 2/3 trial with patients randomized to receive either the darovasertib and crizotinib combination or investigator’s choice of treatment (pembrolizumab, ipilimumab + nivolumab, or dacarbazine).  The primary endpoints are median PFS and median OS, which will be used to support a potential accelerated approval and full approval in the United States, respectively. 

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