Ideaya Biosciences and Servier reported updated results from 3 clinical trials of darovasertib in primary and metastatic uveal melanoma at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain.

In the phase 2 OptimUM-09 trial, neoadjuvant darovasertib produced tumor shrinkage in approximately 80% of patients with primary uveal melanoma. Among patients initially recommended for enucleation, 57% were able to preserve their eyes. In the plaque brachytherapy cohort, 66% achieved reductions in planned radiation doses to critical ocular structures.

The updated analysis included 119 patients, with results largely consistent with previously reported findings.

In metastatic disease, the phase 1/2 OptimUM-01 trial evaluated darovasertib combined with crizotinib in 101 patients with HLA-A*02:01-positive uveal melanoma. The overall response rate was 22.1%, with median progression-free survival of 5.4 months. Among 13 treatment-naïve patients, median progression-free survival was 7.4 months.

Additional subgroup analyses from the phase 2/3 OptimUM-02 trial showed consistent improvements in response rates and progression-free survival compared with investigator-selected therapy in patients with HLA-A*02:01-negative metastatic disease.

Darovasertib, an investigational oral protein kinase C inhibitor, has received FDA breakthrough therapy designation for neoadjuvant treatment of primary uveal melanoma in patients recommended for enucleation.