Core Insights - IDEAYA Biosciences announced updated clinical results for darovasertib, a first-in-class oral small molecular inhibitor of protein kinase C (PKC), in the treatment of uveal melanoma (UM) [1][2] Clinical Trial Results - The ongoing Phase 2 trial of darovasertib showed promising results, with 75% of enucleation patients preserving their eyes and approximately 67% experiencing over 30% tumor shrinkage after 6 months [3][6] - Median tumor shrinkage was reported at approximately 47% for enucleation patients after 6 months [3][6] - In a separate cohort of 8 patients treated for 4 months or more, median tumor shrinkage was approximately 72% [5][6] Safety Profile - Darovasertib demonstrated a manageable adverse event (AE) profile, with no drug-related serious adverse events reported [4][7] - Drug-related AEs were primarily Grade 1 or Grade 2, with about 20% of patients experiencing at least one drug-related Grade 3 AE [4][7] Regulatory Plans - The company is targeting a Type C meeting with the FDA in H2 2024 to discuss a potential registrational trial for darovasertib in the neoadjuvant UM setting [5][6] - The Phase 2 company-sponsored trial has activated over 14 sites globally and enrolled over 40 patients as of May 24, 2024 [5][6] Market Potential - The projected global annual incidence of primary uveal melanoma is approximately 8,000 to 10,000 patients, indicating a significant market opportunity for darovasertib [6][8]
IDEAYA Announces Results for Darovasertib Phase 2 IST in Neoadjuvant Uveal Melanoma at ASCO and Clinical Update for Phase 2 Company-Sponsored Neoadjuvant Study