IDEAYA Biosciences, Inc. (IDYA) has announced the completion of targeted full enrolment of 435 patients in its OptimuUM-02 Phase 2/3 trial, evaluating Darovasertib in combination with Pfizer's Crizotinib in first line HLA*A2-negative metastatic uveal melanoma (mUM).
This enrolment milestone enables a potential full approval filing for the combination therapy. CEO Yujiro S. Hata said that the achievement reflects both the unmet need in (mUM), and strong clinical interest in Darovasertib program.
Metastatic uveal melanoma (mUM) is a rare, aggressive ocular cancer with historically poor survival outcomes and limited treatment options. Patients often face rapid disease progression, underscoring the urgent need for new therapies.
Darovasertib is an investigational oral protein kinase C (PKC) inhibitor, while Crizotinib is an oral c-MET inhibitor. Together, the combination aims to improve progression-free survival and overall survival in patients with HLA*A2-negative mUM.
The OptimUM-02 study is randomized, multi-arm, open-label Phase 2/3 trial comparing Darovasertib plus Crizotinib against investigator's choice of treatment, including pembrolizumab, ipilimumab plus nivolumab, or dacarbazine.
The primary endpoints are median progression-free survival (PFS) and median overall survival (OS). IDEAYA expects to report topline PFS data in the first quarter of 2026 to support a potential accelerated approval filing in the United States.
Earlier results from the Phase 1/2 OptimUM-01 trial demonstrated promising efficacy, with a median overall survival of 21.1 months and median PFS of 7.0 months in first-line mUM patients, including both HLAA2-negative and HLAA2-positive cohorts.
Darovasertib has received FDA Breakthrough Therapy Designation as neoadjuvant therapy in primary uveal melanoma, Fast Track designation in combination with crizotinib for metastatic UM, and Orphan Drug designation for UM, including metastatic UM.
IDYA has traded in the range of $13.45 to $37.08 over the past year. The stock is currently trading in the pre-market at $35.60, up 5.83%.
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