Announcement • Sep 09

IDEAYA Biosciences, Inc. and Servier Dose First Patient in OptimUM-11 Global Phase 3 Registrational Trial of Darovasertib and Crizotinib as Adjuvant Therapy for Uveal Melanoma

IDEAYA Biosciences, Inc. and Servier announced that the first patient has been dosed in OptimUM-11, a global Phase 3 registrational trial evaluating darovasertib, a first-in-class oral protein kinase C (PKC) inhibitor, in combination with crizotinib, an oral cMET inhibitor, as adjuvant therapy for patients with primary uveal melanoma who have completed local therapy and have an increased risk of developing metastatic disease. Currently, there are no approved adjuvant treatment options for patients with primary uveal melanoma. OptimUM-11 is being conducted by IDEAYA in collaboration with its partner, Servier, to evaluate darovasertib in combination with crizotinib as an adjuvant therapy for patients with primary uveal melanoma. The trial is expected to enroll approximately 450 patients who have completed primary local therapy and have an increased risk of metastasis. Patients will be eligible irrespective of HLA status and will be randomized 1:1 to receive darovasertib in combination with crizotinib for 12 months or observation. The primary endpoint of the trial is relapse-free survival. IDEAYA retains regulatory and commercial rights to darovasertib in the United States, while Servier holds all such rights outside the United States. The companies will share the associated development costs of the trial. Darovasertib is a potential first-in-class oral, small-molecule inhibitor of PKC. Darovasertib was designed to inhibit PKC isoforms downstream of the GNAQ and GNA11 oncogenic driver mutations that are present in nearly all uveal melanoma patients. Darovasertib is being evaluated in multiple clinical trials in uveal melanoma, including in patients with metastatic disease (OptimUM-01 and OptimUM-02), as well as in primary uveal melanoma as a neoadjuvant (OptimUM-09 and OptimUM-10) and adjuvant (OptimUM-11) therapy. IDEAYA has initiated submission of a new drug application (NDA) for darovasertib in combination with crizotinib for patients with first line metastatic uveal melanoma (mUM) under the oncology center of excellence (OCE) real-time oncology review (RTOR) program and expects to complete the NDA submission in the second half of 2026. The U.S. Food and Drug Administration (FDA) has also granted darovasertib Fast Track designation for the treatment of mUM, Orphan Drug designation in primary uveal melanoma and Breakthrough Therapy Designation as a neoadjuvant therapy for patients with primary uveal melanoma for whom enucleation has been recommended. Darovasertib is an investigational product and has not been approved by the FDA or any other regulatory authority. Uveal melanoma is a rare and aggressive cancer arising from melanocytes in the eye and is biologically distinct from cutaneous melanoma. An estimated 10,000-12,000 new cases of primary uveal melanoma are diagnosed globally per year, including more than 3,000 new cases annually in the United States. Primary uveal melanoma is generally treated with local therapy, including plaque brachytherapy, radiation or surgical removal of the eye (enucleation). Despite effective control of the primary tumor, up to 50% of primary uveal melanoma patients eventually progress to metastatic disease. There remains a significant unmet need for systemic therapies capable of delaying or preventing metastatic disease progression following treatment of primary uveal melanoma.

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