Ideaya Biosciences Completed Its Targeted Full Enrollment of 435 Patients In Phase 2/3 OptimUM-02 Trial of Darovasertib Combined With Pfizer's Crizotinib for HLA*A2-Negative Metastatic Uveal Melanoma; Median Progression-free Survival Data is Expected in Q1 2026

OptimUM-02 is a multi-arm, multi-stage, open-label Phase 2/3 trial with patients randomized to receive either the darovasertib and crizotinib combination or investigator's choice of treatment (pembrolizumab, ipilimumab + nivolumab, or dacarbazine).  The primary endpoints are median PFS and median OS, which will be used to support a potential accelerated approval and full approval in the United States, respectively.  In October 2025, IDEAYA presented data from its single-arm, Phase 2 trial (OptimUM-01) of the darovasertib and crizotinib combination at the Society for Melanoma Research (SMR) Congress that demonstrated a 21.1 month median OS and 7.0 months median PFS in 1L mUM, including both HLA*A2-negative and HLA*A2-positive patients.

Darovasertib has received U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation as neoadjuvant therapy in enucleation recommended primary uveal melanoma (UM) and Fast Track designation for darovasertib in combination with crizotinib in adult patients with metastatic UM. Darovasertib has also been designated as an Orphan Drug by the U.S. FDA in UM, including in metastatic UM.  IDEAYA is currently enrolling patients in a pivotal Phase 3 trial of single-agent darovasertib in the neoadjuvant setting of primary UM (OptimUM-10).