IDEAYA shares uveal melanoma trial data from three studies at ESMO

IDEAYA Biosciences (Nasdaq: IDYA) and Servier released clinical data from three ongoing trials evaluating darovasertib in uveal melanoma at the European Society for Medical Oncology Congress 2026 in Madrid, Spain.

The OptimUM-01 Phase 2 trial evaluated darovasertib combined with crizotinib in 101 HLA-A*02:01-positive metastatic uveal melanoma patients. Treatment-naïve patients (n=13) showed a median progression-free survival of 7.4 months and median overall survival of 27.1 months. Among 15 patients who had received prior tebentafusp as their only prior systemic therapy, median PFS was 5.7 months and median OS was 12.1 months. The overall response rate across the full population was 22.1%, with a disease control rate of 80.2%. The most common treatment-related adverse events were diarrhea (82%), nausea (76%), peripheral edema (70%), and vomiting (57%).

Subgroup analyses from the registrational Phase 2/3 OptimUM-02 trial showed consistent improvements in ORR and PFS versus investigator's choice of therapy across subgroups defined by baseline lactate dehydrogenase levels, ECOG performance status, and target lesion size in first-line HLA-A*02:01-negative metastatic uveal melanoma patients. The primary OptimUM-02 results, reported in June 2026, showed a median PFS of 6.9 months by blinded independent central review versus 3.1 months in the control arm.

The Phase 2 OptimUM-09 trial evaluated neoadjuvant single-agent darovasertib in 119 primary uveal melanoma patients. Tumor shrinkage was observed in more than 80% of patients. A 57% eye preservation rate was recorded in the enucleation cohort, and 66% of patients in the plaque brachytherapy cohort had a reduction in planned radiation dose to critical eye structures. At 15 months, 86.3% of patients across both cohorts were free from metastasis.

IDEAYA stated it is submitting a new drug application for darovasertib combined with crizotinib for first-line metastatic uveal melanoma under the FDA's real-time oncology review program, with submission expected in the second half of 2026. Darovasertib has not been approved by the FDA or any other regulatory authority.

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