IDEAYA Biosciences announced that results from its multi-site global Phase 2 study of neoadjuvant darovasertib in primary uveal melanoma have been accepted for a Proffered Paper oral presentation at the 2025 European Society of Medical Oncology (ESMO) meeting, scheduled for October 17-21 in Berlin, Germany.
Clinical Data and Patient Population
The presentation will include data from over 90 patients enrolled in both the plaque brachytherapy and enucleation-eligible cohorts. The study focuses on evaluating darovasertib's potential for enucleation prevention and vision preservation in primary uveal melanoma patients.
Dr. Marcus Butler, Associate Professor at Princess Margaret Cancer Center at the University of Toronto, will present the findings under the title "Enucleation prevention and vision preservation in primary uveal melanoma (UM): preliminary results from a phase 2 study of neoadjuvant darovasertib" (Abstract #5053).
Regulatory Recognition and Development Strategy
Darovasertib has received U.S. FDA Breakthrough Therapy Designation for use in neoadjuvant uveal melanoma for subjects requiring enucleation, highlighting the significant unmet medical need in this rare cancer indication.
"We are excited to share clinical data at ESMO 2025 on the effects of neoadjuvant darovasertib in primary uveal melanoma across both plaque brachytherapy and enucleation cohorts. Its potential to impact the natural history of this disease and its management will be highlighted in the presentation," said Dr. Darrin Beaupre, Chief Medical Officer at IDEAYA Biosciences.
Phase 3 Trial Advancement
Building on the Phase 2 results, IDEAYA has initiated a multi-site, global randomized Phase 3 neoadjuvant registrational trial in primary uveal melanoma, designated OptimUM-10, in Q3 2025. This advancement represents a significant milestone in the clinical development strategy for darovasertib in earlier-stage disease.
Dr. Beaupre emphasized the company's continued focus on advancing their clinical strategy for darovasertib in earlier stage disease, noting the recent initiation of the Phase 3 registrational trial.
Company Background
IDEAYA Biosciences is a precision medicine oncology company focused on discovering, developing, and commercializing transformative therapies for unmet medical needs in cancer. The company integrates small-molecule drug discovery, structural biology, and bioinformatics with extensive capabilities in identifying and validating translational biomarkers to develop potentially first-in-class targeted therapies for selected patient populations.
