Ideaya Biosciences to present OptimUM-09 trial data of darovasertib

Ideaya Biosciences (IDYA) will present interim data at their 10-Year Anniversary R&D Day from their ongoing Phase 2 OptimUM-09 trial of darovasertib in the neoadjuvant setting for primary uveal melanoma. The data provide clinical evidence of ocular tumor shrinkage, reduction in radiation doses administered to critical eye structures and, in turn, improved vision with a reduced risk of developing longer-term blindness post-plaque brachytherapy. 76% of patients achieved greater than or equal to 20% ocular tumor shrinkage by product of diameters, the response definition proposed for the Phase 3 registration-enabling OptimUM-10 trial; 48% of patients achieved greater than or equal to 20% reduction in simulated radiation dose to at least one key visual structure, with 86% achieving any reduction. A 20% reduction in radiation dose has previously been shown to correlate with improved visual outcomes. 65% of patients observed any visual improvement during neoadjuvant darovasertib treatment, with a median of 6 letters gained, and 40% of patients achieving greater than five letters gained at two consecutive visits. A vision prognostication tool used to predict the risk of developing 20/200 vision at three years post-plaque brachytherapy showed 67% of patients treated with darovasertib observed “any reduction” in their risk, and 38% observed a greater than or equal to 20% reduction in their risk. Darovasertib was generally well-tolerated with a manageable safety profile. The majority of treatment-related adverse events observed were Grade 1 and 2, with approximately 10% Grade 3 or higher. The most common TRAEs included diarrhea, nausea, fatigue, maculo-papular rash, hypotension, and vomiting. Four patients discontinued treatment due to TRAEs, including two with hepatic transaminase increase, one with nausea, vomiting, fatigue, and one with hypotension, bradycardia and decreased level of consciousness.