US precision medicine oncology company IDEAYA Biosciences Inc (NASDAQ:IDYA) and French pharmaceutical company Servier announced on Monday positive topline results from their Phase 2/3 registrational trial, OptimUM-02, evaluating darovasertib in combination with crizotinib in patients with first-line (1L) HLA-A*A2:01-negative metastatic uveal melanoma (mUM).

The darovasertib combination met the trial's primary endpoint of a statistically significant improvement in median progression-free survival (PFS) relative to the investigator choice of therapy (ICT) arm as assessed by blinded independent central review (BICR). Median PFS was 6.9 months for the darovasertib combination versus 3.1 months for ICT.

Secondary endpoint of overall response rate (ORR) by BICR was 37.1% for the darovasertib combination versus 5.8% for ICT, including five complete responses in the darovasertib combination arm and no complete responses observed in the ICT arm. The median duration of response (DOR) in the darovasertib combination arm was 6.8 months.

Additionally, the darovasertib combination showed an early trend in improvement for overall survival (OS) versus ICT.

The darovasertib combination was generally well-tolerated with a manageable safety profile consistent with prior reported results and known side-effects of each drug.

Based on these data, IDEAYA is targeting submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) in the second half of 2026. It plans to provide additional details from OptimUM-02 at a major medical conference in 2026.