IDEAYA Biosciences, Inc. announced on December 17, 2024, that the Independent Data Monitoring Committee (IDMC) recommended a move-forward dose for its potential registration-enabling Phase 2/3 trial. This trial evaluates the combination of darovasertib and crizotinib in first-line (1L) HLA-A2-negative metastatic uveal melanoma (MUM).
The IDMC's recommendation completes the Part 2a dose optimization, consistent with the U.S. Food and Drug Administration's (FDA) Project Optimus guidelines. This allows for seamless continued enrollment in Part 2b, aiming for potential accelerated approval based on the primary endpoint of median progression-free survival.
The darovasertib and crizotinib combination in MUM has FDA Fast Track designation and has shown compelling preliminary clinical results. The continued rapid enrollment in the trial highlights the significant unmet medical need for patients with MUM, who historically face a poor prognosis.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.