IDEAYA Biosciences(US:IDYA) Prnewswireยท2024-09-23 10:00Core Insights - IDEAYA Biosciences announced positive interim Phase 2 clinical trial data for darovasertib in neoadjuvant uveal melanoma (UM), showing approximately 49% of patients with over 30% tumor shrinkage and a 61% eye preservation rate for enucleation patients [1][2][3] Clinical Trial Data - In the Phase 2 trials, 31 enucleation and 18 plaque brachytherapy evaluable UM patients were treated, with 59% of patients showing over 20% ocular tumor shrinkage and 49% showing over 30% shrinkage [6] - The eye preservation rate observed was 61%, with manageable adverse event (AE) profiles including 11% grade 3 or higher AEs and a 3% discontinuation rate [6] FDA Engagement - A successful FDA Type C meeting has provided a potential registrational path for darovasertib, with primary endpoints of eye preservation and time to vision loss, and no detriment to Event-Free Survival (EFS) as a secondary endpoint [3][9] - Ongoing discussions with the FDA may include Overall Response Rate (ORR) as a potential surrogate endpoint to support earlier approval scenarios [9] Future Trial Plans - IDEAYA plans to initiate a Phase 3 randomized registrational trial in neoadjuvant UM, targeting approximately 400 patients, with two cohorts: enucleation eligible and plaque brachytherapy eligible UM patients [8][9] - The primary endpoint for enucleation patients will be eye preservation rate, while time to vision loss will be the primary endpoint for plaque brachytherapy patients [9] Market Opportunity - The annual incidence of primary UM in North America, Europe, and Australia is projected to be around 12,000 patients, representing a significant market opportunity for darovasertib, as there are currently no FDA-approved therapies for this condition [1][10] Company Overview - IDEAYA Biosciences is focused on precision medicine in oncology, developing targeted therapeutics and integrating capabilities in identifying and validating translational biomarkers [14]