Ideaya announces IDMC recommendation for darovasertib, crizotinib combination

Ideaya Biosciences (IDYA) announced the Independent Data Monitoring Committee, or IDMC, recommendation of a move-forward dose and the completion of the Part 2a dose optimization consistent with the FDA’s Project Optimus guidelines for the potential registration-enabling Phase 2/3 trial evaluating the combination of darovasertib and crizotinib in the first-line setting in patients with HLA-A2-negative metastatic uveal melanoma. The darovasertib and crizotinib combination in MUM has FDA Fast Track designation and is currently being evaluated in two clinical trials: a potentially registration-enabling Phase 2/3 trial of darovasertib and crizotinib combination in first-line HLA-A2 MUM and a Phase 2 trial. Additionally, darovasertib as neoadjuvant monotherapy is currently being evaluated in a Phase 2 trial in primary uveal melanoma. IDEAYA is also finalizing a clinical trial protocol and is targeting to initiate a potential Phase 3 registration-enabling study for neoadjuvant uveal melanoma patients in the first half of 2025.