On October 20, 2025, IDEAYA Biosciences, Inc. presented positive clinical data from its Phase 2 OptimUM‑09 trial of neoadjuvant darovasertib in patients with primary uveal melanoma (UM) at the European Society of Medical Oncology (ESMO) conference in Berlin. The presentation, delivered by Dr. Marcus Butler, M.D., included results from 95 primary UM patients—56 in Cohort 1 (enucleation‑recommended) and 39 in Cohort 2 (plaque brachytherapy‑eligible). Of the 95 patients, 94 were evaluable for efficacy, demonstrating meaningful tumor shrinkage, eye preservation, and a reduced predicted risk of severe vision loss.
The data represent the first systemic therapy results for neoadjuvant primary UM, a disease with no approved systemic treatments. The trial’s outcomes support the potential for darovasertib to become the first systemic therapy in this setting, offering patients a chance to preserve their eye and vision while delaying or preventing metastatic progression. These findings are a critical step toward regulatory submissions and could accelerate the drug’s path to approval.
For investors, the positive Phase 2 data signal a significant milestone that may broaden IDEAYA’s market opportunity and strengthen its competitive position in precision oncology. The results also reinforce the company’s pipeline strategy and could enhance investor confidence in the company’s ability to translate clinical success into regulatory and commercial milestones.
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