South San Francisco, Calif. – September 12, 2026 -- IDEAYA Biosciences and Servier have dosed the first patient in OptimUM-11, a global Phase 3 trial testing darovasertib combined with crizotinib as adjuvant therapy for primary uveal melanoma, targeting a disease segment with no approved systemic treatment options.
Trial design pairs oral PKC and cMET inhibitors for high-risk patients post-local therapy
OptimUM-11 will enroll approximately 450 patients who have completed local therapy for primary uveal melanoma and face elevated risk of metastatic recurrence. Patients will be randomized 1:1 to receive darovasertib plus crizotinib for 12 months or to observation, regardless of HLA status. The primary endpoint is relapse-free survival.
Up to 50% of primary uveal melanoma patients progress to metastatic disease
Uveal melanoma affects an estimated 10,000-12,000 patients globally each year, including more than 3,000 in the United States. Despite effective control of the primary tumor via plaque brachytherapy, radiation or enucleation, up to half of patients eventually develop metastatic disease, for which no adjuvant systemic therapy is currently approved.
IDEAYA retains US rights while Servier controls ex-US commercialization
Under the collaboration, IDEAYA Biosciences holds regulatory and commercial rights to darovasertib in the United States, while Servier holds rights in all other markets. The two companies will share development costs for OptimUM-11.
Darovasertib program expands beyond metastatic setting toward earlier intervention
Darovasertib is already under evaluation in metastatic uveal melanoma trials OptimUM-01 and OptimUM-02, and in neoadjuvant settings via OptimUM-09 and OptimUM-10. IDEAYA has initiated a new drug application for darovasertib combined with crizotinib in first-line metastatic uveal melanoma under the FDA's Real-Time Oncology Review program, with submission completion expected in the second half of 2026.
The FDA has granted darovasertib Fast Track designation for metastatic uveal melanoma, Orphan Drug designation for primary uveal melanoma, and Breakthrough Therapy Designation as a neoadjuvant therapy for patients recommended for enucleation.