Ideaya Biosciences announces interim darovasertib trial data

Ideaya Biosciences announced interim Phase 2 clinical trial data for darovasertib in neoadjuvant uveal melanoma, or UM, and an FDA Type C meeting on registrational trial design for regulatory approval in neoadjuvant UM. The company observed further evidence of encouraging clinical activity from an ongoing company-sponsored Phase 2 trial evaluating darovasertib in neoadjuvant uveal melanoma. The data cut-off date is August 15, with an enrollment cut-off of May 13, for the Phase 2 company-sponsored trial. Collectively, these clinical efficacy data from the Phase 2 company-sponsored and IST further substantiate clinical proof of concept for the use of darovasertib in the neoadjuvant uveal melanoma setting. Clinical data update highlights include: 31 enucleation and 18 plaque brachytherapy evaluable UM patients treated with darovasertib neoadjuvant therapy in Phase 2 company-sponsored and IST trials; 59% of patients with greater than 20% ocular tumor shrinkage by product of diameters; 49% of patients with greater than30% ocular tumor shrinkage by product of diameters; 61% eye preservation rate observed. Evidence of visual preservation observed by reducing the amount of radiation associated with plaque brachytherapy. Manageable AE profile observed from Phase 2 company-sponsored trial, including 11% grade 3 or higher AEs, and 5% serious AE rate. The discontinuation rate observed was 3%. The most common AEs observed included diarrhea, nausea, vomiting and fatigue. Ideaya’s ocular oncology advisory board recommended product of diameters for tumor measurement to determine overall response rate criteria in ocular melanoma. In Ideaya’s ongoing Phase 2 clinical study with darovasertib, a greater than 20% ocular tumor shrinkage by product of diameters correlates to clinical benefit, including eye sparing for enucleation UM patients and visual preservation for plaque brachytherapy UM patients. Ideaya 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. The randomized Phase 3 clinical trial design incorporates guidance and feedback from the U.S. FDA following a recent Type C meeting.