Core Insights - The Independent Data Monitoring Committee (IDMC) has recommended a move-forward dose for the darovasertib and crizotinib combination in a Phase 2/3 trial for first-line HLA-A2-negative metastatic uveal melanoma (MUM) based on observed clinical efficacy and safety [1][3] - Over 185 patients have been enrolled in this trial, which has received FDA Fast Track designation, indicating a potential for accelerated approval [1][4] Company Overview - IDEAYA Biosciences is a precision medicine oncology company focused on discovering and developing targeted therapeutics, utilizing molecular diagnostics to select patient populations most likely to benefit from its therapies [5] - The company is advancing its research in synthetic lethality, an emerging class of precision medicine targets [5] Clinical Trial Progress - The darovasertib and crizotinib combination has shown promising preliminary clinical results, supporting the advancement of the trial and addressing significant unmet needs in MUM patients [3] - The company is finalizing a clinical trial protocol for a potential Phase 3 registration-enabling study for neoadjuvant uveal melanoma patients, targeting initiation in the first half of 2025 [4]
IDEAYA Announces IDMC Recommendation of Move-Forward Dose in Part 2a of Registration-Enabling Trial of Darovasertib and Crizotinib Combination in 1L HLA-A2-Negative Metastatic Uveal Melanoma