IDEAYA and Servier say OptimUM-02 met its primary endpoint in metastatic uveal melanoma, supporting a planned U.S. filing in late 2026.
IDEAYA Biosciences and Servier say their OptimUM-02 trial has delivered positive topline results in metastatic uveal melanoma.
The companies said the Phase 2/3 registrational study met its primary endpoint, showing a statistically significant improvement in progression-free survival for darovasertib in combination with crizotinib versus investigator-chosen therapy. Reuters reported median PFS of 6.9 months for the combination compared with 3.1 months for the control arm.
IDEAYA said the data support a planned U.S. NDA submission in the second half of 2026. The companies said they will provide additional details later this year.
The announcement is the latest step in a program that could give patients with first-line HLA-A*02:01-negative metastatic uveal melanoma a new treatment option if the results hold up in a full review of the data.
The companies did not immediately release all subgroup or longer-term follow-up details in the topline announcement.
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