IDEAYA Biosciences Reveals ASCO 2024 Phase 2 Study Results of Darovasertib in Neoadjuvant Uveal Melanoma

IDEAYA Biosciences, Inc., a precision medicine oncology company, recently unveiled the abstract for an upcoming oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The presentation will focus on preliminary clinical results from their Phase 2 trial of darovasertib, an oral small-molecule inhibitor of protein kinase C (PKC), used as neoadjuvant/adjuvant treatment in uveal melanoma (UM).

Anthony Joshua, MBBS, PhD, FRACP, Head of the Department of Medical Oncology at the Kinghorn Cancer Centre, St. Vincent's Hospital in Sydney, and the principal investigator of the Phase 2 study, will present the clinical data. The presentation is scheduled for June 3, 2024, at 9:51 AM CDT under the session "Melanoma / Skin Cancers."

The Phase 2 trial, named the Neoadjuvant / Adjuvant trial of Darovasertib in Ocular Melanoma (NADOM), enrolled 15 patients with localized UM who were planned for enucleation. Initially, a safety cohort of three patients received darovasertib 300mg twice daily for one month. Subsequently, 12 more patients were treated in an expansion cohort for up to six months as neoadjuvant therapy before their primary interventions, which included enucleation, plaque brachytherapy, or external beam radiotherapy (EBRT), across three Australian centers.

By the database lock date, 11 patients had completed their primary treatment, while four continued with neoadjuvant therapy. Additionally, six patients received adjuvant darovasertib following their primary treatment for UM, with three completing the planned six-month course. Remarkably, about 67% (6 out of 9) of the patients slated for enucleation had their eyes preserved by switching to plaque brachytherapy or EBRT. Furthermore, median tumor shrinkage after six months of treatment was approximately 39%.

The darovasertib monotherapy was generally well tolerated among the patients. The adverse events (AEs) related to the drug were primarily mild to moderate (Grade 1 or Grade 2). Thirteen percent of the patients experienced at least one drug-related Grade 3 adverse event, but there were no drug-related serious adverse events reported.

Additional patient data and follow-up information from the abstract summary cut-off date will be presented during the ASCO session on June 3, 2024. The oral presentation will be accessible via IDEAYA's Investor Relations portal under "Events" at approximately 10:00 AM CDT on the day of the presentation.

IDEAYA Biosciences, a leader in precision medicine oncology, focuses on discovering and developing targeted therapeutics for patient populations identified through molecular diagnostics. Their strategy combines identifying and validating translational biomarkers with drug discovery to select patient groups most likely to benefit from their treatments. IDEAYA is also advancing research in synthetic lethality, an emerging precision medicine target.

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