IDEAYA Biosciences, Inc. announced positive interim Phase 2 clinical trial data for darovasertib in neoadjuvant uveal melanoma (UM) on September 23, 2024. Approximately 49% of patients demonstrated greater than 30% tumor shrinkage, and a 61% eye preservation rate was observed for enucleation patients.
The company also reported a successful FDA Type C meeting regarding the registrational trial design for regulatory approval in neoadjuvant UM. This meeting established a potential registrational path using primary clinical endpoints of eye preservation and time to vision loss.
Darovasertib, a potent and selective protein kinase C (PKC) inhibitor, is being developed to address primary and metastatic UM. The company is targeting to initiate a potential registration-enabling Phase 3 randomized clinical trial in neoadjuvant UM patients following finalization of the clinical protocol with the FDA.
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