On September 9, 2026 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, and Servier, an independent international pharmaceutical group governed by a foundation, reported 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.
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"Dosing the first patient in OptimUM-11 represents an important milestone in our strategy to advance darovasertib across the uveal melanoma patient journey," said Darrin M. Beaupre, M.D., Ph.D., Chief Medical Officer of IDEAYA Biosciences. "Patients with primary uveal melanoma are commonly at risk for metastatic recurrence following treatment of their primary tumor, highlighting the need for an effective systemic therapy in the adjuvant setting to delay or prevent disease progression. We believe the darovasertib combination has the potential to address the principal pathways associated with the initiation and metastatic progression of uveal melanoma, and we look forward to working with our partner Servier and the global investigator community to advance this registrational trial."
"Preventing or delaying metastatic recurrence could fundamentally change the treatment journey for patients with high-risk primary uveal melanoma," said Arnaud Lallouette, Executive Vice President Global Medical & Patient Affairs at Servier. "Through OptimUM-11, Servier and IDEAYA are jointly advancing a global registrational study of the darovasertib combination with the goal of establishing a new adjuvant treatment option for patients worldwide."
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.
About Darovasertib
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.
(Press release, Ideaya Biosciences, SEP 9, 2026, View Source [SID1234670689])