IDEAYA and Servier Report Positive Phase 2/3 Trial Results for Darovasertib in Metastatic Uveal Melanoma, Paving Way for FDA Filing

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The Phase 2/3 OptimUM-02 trial of darovasertib combined with crizotinib met its primary endpoint, achieving median PFS of 6.9 months vs. 3.1 months for investigator's choice of therapy (HR: 0.42; p<0.0001) in HLA-A*02:
01-negative metastatic uveal melanoma patients.123

IDEAYA plans to submit an NDA for accelerated FDA approval in the second half of 2026, with full data to be presented at a major medical conference in 2026.13

The trial enrolled 210 patients on the experimental arm and 103 on control; overall response rate was 37.1% vs. 5.8%, with a manageable safety profile.12

IDEAYA shares rose up to 21% in premarket trading on April 13, 2026, following the announcement.12

Servier holds ex-U.S. rights via a $210M upfront deal with potential milestones up to $320M plus royalties; partners plan further trials in adjuvant and neoadjuvant settings.14

Sources:

1. https://www.fiercebiotech.com/biotech/ideaya-sees-clear-path-fda-servier-partnered-eye-cancer-drug-hits-goal

2. https://www.biospace.com/drug-development/ideaya-and-serviers-eye-cancer-drug-heads-to-fda-after-delivering-best-in-class-efficacy

3. https://www.biospace.com/press-releases/ideaya-biosciences-and-servier-announce-positive-topline-results-from-phase-2-3-registrational-trial-optimum-02-of-darovasertib-in-combination-with-crizotinib-in-first-line-hla-a-02-01-negative-metastatic-uveal-melanoma

4. https://www.prnewswire.com/news-releases/servier-and-ideaya-biosciences-partner-to-bring-darovasertib-a-promising-uveal-melanoma-treatment-to-patients-worldwide-302543276.html