IDEAYA and Servier Launch Phase 3 Uveal Melanoma Trial

South San Francisco, California and Paris, France, September 9, 2026

OptimUM-11 Begins Global Phase 3 Development

The OptimUM-11 Phase 3 study is a randomized, open-label, multicenter clinical trial intended to evaluate darovasertib in combination with crizotinib as an adjuvant treatment for patients with uveal melanoma who are at high risk of recurrence. The trial is designed as a registrational study, meaning results could potentially form the basis of future regulatory submissions if the combination demonstrates a favorable benefit-risk profile. Uveal melanoma develops from melanocytes within the eye and differs biologically and clinically from cutaneous melanoma. Although local treatment can control the primary ocular tumor, patients with high-risk disease remain vulnerable to metastatic recurrence, particularly in the liver. Once metastatic disease develops, treatment options remain limited, creating a significant unmet medical need for therapies capable of delaying or preventing recurrence. The OptimUM-11 program is therefore investigating whether treatment administered after definitive management of the primary tumor can address microscopic residual disease and reduce the likelihood of metastatic recurrence.

Darovasertib Combination Targets Key Pathways

Darovasertib is an investigational small-molecule inhibitor of protein kinase C (PKC), a signaling protein involved in pathways driven by mutations in GNAQ and GNA11. These mutations are frequently associated with uveal melanoma and can contribute to abnormal signaling that supports tumor-cell growth and survival. Crizotinib, meanwhile, is a multikinase inhibitor that targets proteins including MET, ALK and ROS1. The combination is being investigated based on the potential for complementary pathway inhibition in uveal melanoma. By targeting signaling pathways associated with tumor growth and survival, the companies aim to develop a treatment strategy capable of suppressing disease progression following initial treatment. The clinical rationale is particularly important in uveal melanoma because the disease has distinct molecular characteristics compared with other melanoma subtypes. Targeting molecular drivers such as GNAQ/GNA11-associated signaling represents an approach designed specifically around the biology of the disease. However, darovasertib remains an investigational therapy, and the combination with crizotinib has not been established as an approved adjuvant treatment for uveal melanoma.

Phase 3 Trial Designed for Registrational Evidence

The initiation of OptimUM-11 follows earlier clinical development of darovasertib in uveal melanoma, including studies evaluating the drug in combination regimens for patients with advanced disease. Moving into a global Phase 3 registrational trial represents a substantial escalation in the development program and will generate more definitive evidence regarding efficacy and safety. The study will assess clinical outcomes relevant to recurrence and disease control while continuing to characterize the safety profile of the combination. As an adjuvant trial, the primary objective is not simply to shrink measurable tumors but to determine whether treatment can delay or prevent recurrence in patients who have undergone treatment for their primary disease. The companies expect OptimUM-11 to enroll patients across multiple geographic regions, supporting a broad evaluation of the treatment strategy. The global design is intended to generate evidence applicable to diverse patient populations and provide the data required for potential future regulatory review. The first-patient dosing milestone does not itself demonstrate clinical efficacy. The ultimate value of the regimen will depend on results from the full Phase 3 study, including its predefined efficacy endpoints, safety findings and duration of follow-up. For IDEAYA and Servier, the start of OptimUM-11 represents a significant clinical development and regulatory milestone. If successful, the study could support a future application for the combination as an adjuvant treatment for high-risk uveal melanoma. The program also highlights the growing focus on molecularly targeted therapies for rare cancers, particularly diseases in which the risk of metastatic recurrence remains high despite effective local treatment. Continued clinical development of darovasertib and crizotinib could provide important evidence on whether targeting PKC and related signaling pathways can change the course of uveal melanoma after initial treatment.

Source: IDEAYA Biosciences press release