IDEAYA and Servier disclose complete Phase 2/3 data for uveal melanoma combo therapy

IDEAYA Biosciences (NASDAQ:IDYA) and Servier reported complete data Monday from the primary analysis of their registrational Phase 2/3 OptimUM-02 clinical trial.

The global study evaluated the oral combination of darovasertib and crizotinib as a first-line treatment for patients with HLA*A2:01 negative metastatic uveal melanoma.

The updated dataset, delivered in a late-breaking oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, showed that the dual-drug regimen achieved a statistically significant and clinically meaningful improvement across all primary and secondary efficacy metrics compared to standard investigator's choice of therapy.

The randomized registrational trial met its core efficacy benchmarks, demonstrating substantial extensions in median progression-free survival (PFS) alongside marked improvements in both the overall response rate (ORR) and the disease control rate (DCR).

According to the joint release, the safety profile of the darovasertib and crizotinib combination remained manageable and fully aligned with previously reported clinical observations, showing low overall rates of treatment discontinuation.

The darovasertib combination program is currently being evaluated by the U.S. Food and Drug Administration (FDA) under the Real-Time Oncology Review (RTOR) pilot program.

The regulatory pathway is designed to expedite the analysis of data to bring safe and efficient cancer therapies to patients as early as possible.

Based on the strength of the complete OptimUM-02 dataset, South San Francisco-based IDEAYA and its international partner Servier confirmed that they are actively targeting the completion of their New Drug Application (NDA) submission to the FDA within the second half of 2026.