IDEAYA and Servier Report Positive Topline Results for Darovasertib in Metastatic Uveal Melanoma
IDEAYA Biosciences and Servier have announced positive topline results from the Phase 2/3 registrational trial, OptimUM-02. The study evaluated the efficacy of darovasertib, an investigational oral protein kinase C (PKC) inhibitor, in combination with crizotinib (an oral c-MET inhibitor) for patients with first-line (1L) HLA-A*02:01-negative metastatic uveal melanoma (mUM).
Metastatic uveal melanoma is a rare and aggressive ocular cancer known for limited treatment options and historically poor survival outcomes. The OptimUM-02 trial is the first randomized study to demonstrate a statistically significant and clinically meaningful benefit in progression-free survival (PFS) for this specific patient population.
Key Clinical Findings
The trial successfully met its primary endpoint, demonstrating a significant improvement in median PFS as assessed by blinded independent central review (BICR). The data highlights a clear advantage for the darovasertib combination over the investigator choice of therapy (ICT):
- Median Progression-Free Survival (PFS): 6.9 months for the darovasertib combination versus 3.1 months for ICT (HR: 0.42; 95% CI: 0.30, 0.59; p-value: <0.0001).
- Overall Response Rate (ORR): 37.1% for the darovasertib combination compared to 5.8% for ICT (p-value: <0.0001), which included five complete responses in the darovasertib arm.
- Overall Survival (OS): While full data is pending, the darovasertib combination showed an early trend toward improvement in OS compared to ICT.
Regarding safety, the combination was reported as well-tolerated, with a manageable safety profile consistent with previously reported adverse events.
Strategic Timeline and Regulatory Path
IDEAYA has completed the targeted full enrollment of 435 patients to support a potential full approval filing. The company is now moving toward regulatory submission in the United States.
An NDA submission is planned for the second half of 2026 to support a U.S. Accelerated approval filing. While median PFS data will support the accelerated filing, median overall survival (mOS) data will be used to support a potential full approval filing once available.
Summary of OptimUM-02 Results
| Metric | Darovasertib Combination | Investigator Choice (ICT) | Statistical Significance |
|---|---|---|---|
| Median PFS (BICR) | 6.9 months | 3.1 months | p-value <0.0001 |
| ORR (BICR) | 37.1% | 5.8% | p-value <0.0001 |
| Complete Responses | 5 | Not Specified | N/A |
What’s Next for IDEAYA Biosciences?
Following the announcement of these topline results on April 13, 2026, IDEAYA plans to present the full data from the OptimUM-02 trial at a major medical conference later in 2026. These results mark a critical milestone in the development of a potential first-line treatment for HLA-A2-negative metastatic uveal melanoma.
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