IDEAYA Biosciences and Servier reported positive topline results from the Phase 2/3 registrational OptimUM-02 trial evaluating darovasertib in combination with crizotinib as first-line therapy for patients with HLA-A*02:01-negative metastatic uveal melanoma (mUM). The randomized study compared the darovasertib–crizotinib combination to investigator’s choice of therapy (ICT), which included pembrolizumab, ipilimumab plus nivolumab, or dacarbazine.
The trial met its primary endpoint, demonstrating a statistically significant improvement in median progression-free survival (PFS) by blinded independent central review. Median PFS was 6.9 months for patients receiving the darovasertib combination compared with 3.1 months for those treated with ICT, corresponding to a hazard ratio of 0.42 (95% CI: 0.30, 0.59; p<0.0001). The key secondary endpoint of overall response rate (ORR) by blinded independent central review was 37.1% in the darovasertib arm versus 5.8% in the ICT arm (p<0.0001), including five complete responses with the combination regimen.
According to IDEAYA and Servier, the darovasertib–crizotinib combination showed an early trend toward improved overall survival compared with ICT. The companies reported that the combination was well tolerated, with a manageable safety profile consistent with previously observed adverse events for the regimen. Based on these results, IDEAYA plans to submit a New Drug Application in the second half of 2026 to support a potential U.S. accelerated approval, and full data from OptimUM-02 are expected to be presented at a major medical conference in 2026.
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