IDEAYA Biosciences dosed the first patient in OptimUM-11, a global Phase 3 registrational adjuvant trial in primary uveal melanoma.
Results have not been presented; the study will assess whether the darovasertib-crizotinib regimen can delay or prevent metastatic recurrence.
About 450 high-risk patients post-local therapy will be randomized to 12 months of treatment or observation, with relapse-free survival as the primary endpoint.
The program targets a market with no approved adjuvant systemic options in primary uveal melanoma, expanding darovasertib’s commercial opportunity.
IDEAYA keeps U.S. rights to darovasertib; Servier holds ex-U.S. rights, with development costs for the Phase 3 trial shared.
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