IDEAYA Biosciences and Servier Announce Data From Three Clinical Trials at ESMO 2026 Supporting the Potential of Darovasertib to Become a Foundational New Therapy for Patients Across the Treatment Journey of Uveal Melanoma
IDEAYA Biosciences and Servier announced updated ESMO 2026 data from three darovasertib trials in uveal melanoma, spanning metastatic and primary disease settings. OptimUM-01 showed median PFS of 7.4 months and median OS of 27.1 months in treatment-naive metastatic UM — well above historical benchmarks of ~2.8 and ~12 months — while OptimUM-02 subgroup analyses confirmed PFS gains over investigator's choice in HLA-A*02:01-negative 1L disease. OptimUM-09 neoadjuvant data showed tumor shrinkage in ~80% of primary UM patients, a 57% eye preservation rate, and 86.3% metastasis-free at 15 months.
Key figures
- Drug Name
- darovasertib
- Phase Of Trial
- Phase 2/3
- Optimum01 1l os
- 27.1 months
- Optimum01 1l orr
- 36.4%
- Optimum01 1l pfs
- 7.4 months
- Nda submission timing
- second half of 2026
- Optimum01 overall orr
- 22.1%
- Optimum01 overall pfs
- 5.4 months
- Optimum02 1l pfs bicr
- 6.9 months vs 3.1 months control
- Optimum09 metastasis free 15mo
- 86.3%
- Optimum01 prior tebentafusp orr
- 35.7%
- Optimum09 eye preservation rate
- 57%
- Optimum09 tumor shrinkage ge20pct
- 57.8%
AI analysis
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