Darovasertib data from three ongoing uveal melanoma trials will be presented at ESMO Congress 2026, IDEAYA Biosciences announced on October 19, 2026. The updates cover combination treatment for metastatic disease and treatment before local therapy for primary eye cancer. The presentations are scheduled for October 24 in Madrid, Spain; darovasertib remains investigational.
Key Takeaways
- Two metastatic-disease studies evaluate darovasertib plus crizotinib across different HLA-A*02:01 patient groups.
- Primary-disease findings include eye preservation and reductions in planned radiation exposure.
- IDEAYA expects to complete its U.S. application for the metastatic combination in the second half of 2026.
Table of Contents
- Darovasertib data extend the metastatic treatment evidence
- Primary-disease study focuses on preserving the eye
- Safety findings remain part of the assessment
- U.S. application remains in progress
- Conclusion
Darovasertib data extend the metastatic treatment evidence
IDEAYA’s October 2026 clinical update covers OptimUM-01, OptimUM-02 and OptimUM-09. The first two evaluate darovasertib with crizotinib in metastatic uveal melanoma, while the third tests darovasertib alone before local treatment of primary disease.
The OptimUM-01 update focuses on 101 patients with HLA-A*02:01-positive metastatic disease, using a March 23, 2026 cutoff. Approximately 66% had received at least two prior treatment lines. In the small, treatment-naïve group of 13 patients, median progression-free survival was 7.4 months and median overall survival was 27.1 months.
Across all 101 enrolled patients, median progression-free survival was 5.4 months and median overall survival was 13.4 months. OptimUM-01 is a single-arm study, so these results do not establish superiority over another treatment.
OptimUM-02 provides a randomized comparison in previously untreated, HLA-A*02:01-negative metastatic disease. Results announced in June 2026 showed median progression-free survival of 6.9 months with the combination versus 3.1 months with investigator-selected therapy, measured by blinded independent central review. The ESMO update adds subgroup analyses that IDEAYA said showed consistent response and progression-free survival improvements across several baseline disease characteristics.
| Item | Details |
|---|---|
| OptimUM-01: common treatment-related events | Diarrhea 82%; nausea 76%; peripheral edema 70%; vomiting 57%. |
| OptimUM-01: related-event discontinuations | Nine participants, or 8.9%. |
| OptimUM-09: common treatment-related events | Diarrhea 64%; nausea 58%; fatigue 33%; vomiting 28%. |
| OptimUM-09: treatment-related serious events | 6.0% of patients; hypotension was the most common at 3.4%. |
Primary-disease study focuses on preserving the eye
OptimUM-09 evaluates darovasertib before either surgical removal of the eye or plaque brachytherapy, a local radiation treatment. Its two cohorts measure eye preservation and planned radiation-dose reduction, respectively.
The abstract data cover 116 patients as of February 23, 2026. A 57% eye-preservation rate was observed in the cohort initially requiring eye removal, while 66% of patients in the brachytherapy cohort achieved a reduction in planned radiation dose to critical eye structures.
The presentation will include a later June 15 cutoff covering 119 patients. IDEAYA described those updated findings as largely consistent with the earlier results. Reduced planned radiation exposure is distinct from a confirmed long-term improvement in vision.
Safety findings remain part of the assessment
IDEAYA described the safety profiles as manageable. Gastrointestinal adverse events were common, and some patients discontinued treatment. The figures below come from different studies and treatment settings and should not be treated as a direct safety comparison.
U.S. application remains in progress
IDEAYA said it is submitting a new drug application for darovasertib with crizotinib in first-line metastatic uveal melanoma under the FDA’s real-time oncology review program. It expects to complete the submission in the second half of 2026; that timing is a company expectation, not a completed filing or approval.
Darovasertib has not been approved by the FDA or any other regulatory authority. Under a 2025 licensing agreement, Servier holds regulatory and commercial rights outside the United States, and the companies share clinical-development costs.
Conclusion
The next scheduled milestone is the October 24 ESMO poster session, when the three trial updates will be presented. The later OptimUM-09 cutoff and metastatic subgroup findings will add detail to an investigational program whose U.S. application remains in progress.
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