Ideaya Biosciences, Inc., a precision medicine oncology firm dedicated to developing targeted therapies, has reported updated clinical results from the ongoing phase 2 trial of darovasertib, an oral inhibitor of protein kinase C (PKC), used as a neoadjuvant/adjuvant treatment for uveal melanoma (UM). These findings were shared during an oral presentation at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting.
Yujiro S. Hata, President and CEO of Ideaya Biosciences, noted that the ASCO-presented data further validates darovasertib’s potential to preserve the eye and reduce ocular tumors in UM patients. He emphasized the significant unmet medical needs and potential treatment opportunities in neoadjuvant and adjuvant UM, which could expand the patient population for darovasertib beyond metastatic cases.
Darrin Beaupre, M.D., Ph.D., Chief Medical Officer of Ideaya, highlighted the drug’s promising tumor-shrinking effects and its ability to prevent enucleation with manageable side effects. Ideaya plans to seek FDA guidance in late 2024 for a potential registrational trial in neoadjuvant UM and is encouraged by the rapid enrollment and preliminary efficacy and safety results from their company-sponsored phase 2 trial.
Anthony Joshua, MBBS, PhD, FRACP, and the lead principal investigator of the phase 2 study, presented the clinical results at ASCO. Fifteen patients scheduled for enucleation were treated with darovasertib 300mg twice daily, with significant tumor shrinkage and eye preservation observed in the majority of cases. Specifically, 75% of patients had their eyes saved, and 67% saw more than 30% tumor shrinkage over six months.
The treatment had a manageable adverse event (AE) profile, with no serious drug-related AEs and predominantly mild to moderate side effects. Ideaya plans further discussions with the FDA regarding a potential registrational trial and continues to update on their phase 2 neoadjuvant UM trial, which has enrolled over 40 patients globally with promising early results.
As reported by Pharmabiz.com, Ideaya’s darovasertib program includes ongoing trials for HLA-A2-negative metastatic UM and neoadjuvant/adjuvant UM, having received FDA Fast Track and Orphan Drug designations. The global incidence of primary uveal melanoma is estimated at 8,000 to 10,000 patients annually, primarily in the US and Europe.