IDEAYA Biosciences, Inc. announced clinical data presented at a proffered paper session of the European Society of Medical Oncology Congress 2023 (ESMO 2023) from the company's ongoing Phase 2 clinical trial evaluating darovasertib in combination with crizotinib in patients having metastatic uveal melanoma (MUM). In the ongoing investigator-sponsored Phase 1 clinical trial (IST) captioned as "Neoadjuvant /Adjuvant trial of Darovasertib in Ocular Melanoma" (NADOM) being led by principal investigator Professor Anthony Joshua, MBBS, PhD,FRACP, Head Department of Medical Oncology, Kinghorn Cancer Centre, St. Vincent's Hospital in Sydney with participating sites of Alfred Health and the Royal Victorian Eye and Ear Hospital in Melbourne, the study reports a preliminary interim update with an enrollment cut-off as of July 17, 2023 of seven patients treated to maximum response in the neo-adjuvant setting (up to 6 months of darovasertib monotherapy in patients who were enrolled with planned enucleation); 2 patients have confirmed Eye Saved (i.e., converted to plaque brachytherapy) with a third patient confirmed as plaque-eligible and is ongoing with darovasertib neo-adjuvant treatment until maximal benefit; providing 50% overall eye preservation rate for the evaluable patients.

Of the evaluable patients (6 of 7) treated to maximal benefit, defined as at least one ultrasound scan, approximately 83% of patients had tumor shrinkage. Two patients did not complete their treatment to maximal response; one patient had sub-retinal blood present at baseline and with lack of shrinkage and visual deterioration, the patient discontinued treatment after 6 weeks. A non-evaluable second patient had a Grade 3 drug-related AE of dermatitis and discontinued treatment before first scan.

Two out of four additional patients after the enrollment cutoff date of July 17, 2023 are likely plaque eligible and are continuing darovasertib neoadjuvant therapy until maximal benefit with 1 patient being enucleated. In total, 11 patients eligible to receive 6 months of neoadjuvant therapy are enrolled to date in the neoadjuvant UM enucleation cohort IST. IDEAYA's Phase 2 company sponsored (neo)adjuvant darovasertib monotherapy study is observing rapid enrollment to date, with 6 UM patients now enrolled, including 4 enucleation patients and 2 plaque-therapy patients.