IDEAYA And Servier Report Positive Phase 3 Data For Darovasertib Combo Shows Strong Efficacy In Metastatic Uveal Melanoma Trial

IDEAYA Biosciences and Servier have announced positive topline results from the Phase 2/3 OptimUM-02 trial evaluating darovasertib in combination with crizotinib for first-line treatment of HLA-A*02:01-negative metastatic uveal melanoma (mUM). The study met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival (PFS) compared to investigator’s choice of therapy (ICT), as assessed by blinded independent central review.

"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. For patients with uveal melanoma, these results potentially offer a new treatment option that delivers a significant clinical advancement in both PFS and ORR versus currently available therapies," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.

Patients receiving the darovasertib combination showed a 58% reduction in the risk of disease progression, with median PFS reaching 6.9 months versus 3.1 months in the ICT arm. The overall response rate (ORR) was also significantly higher at 37.1% compared to 5.8% in the control group, with five complete responses observed in the combination arm and none in the ICT group. The median duration of response was reported at 6.8 months, reinforcing the therapy’s clinical potential.

"This is a very encouraging milestone demonstrating the potential of this combination in the first-line treatment landscape for patients with metastatic uveal melanoma. Our collaboration with IDEAYA reflects a shared commitment to advancing research and bringing a potential first-in-class treatment to patients," said Claude Bertrand, Executive Vice President Research and Development, Servier.

While overall survival data remains immature, early trends suggest a potential survival benefit with the darovasertib combination. The treatment was generally well tolerated, with a manageable safety profile consistent with known effects of the individual drugs. The most common serious adverse events included diarrhea, syncope, and hypotension, with treatment-related serious events occurring at low rates.

"Metastatic uveal melanoma is an area of high unmet medical need with poor prognosis and short overall survival, and there are currently no approved therapies for HLA-A*02:01-negative mUM patients. The data from the OptimUM-02 study provides potential practice changing results for the treatment of first-line metastatic uveal melanoma," said Dr. Meredith McKean, Sarah Cannon Research Institute.

Based on these results, IDEAYA plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration in the second half of 2026. Additional data from the OptimUM-02 trial is expected to be presented at a major medical conference later this year.