IDEAYA Biosciences, Inc. announced the achievement of First-Patient-In for the company-sponsored Phase 2 clinical trial evaluating Darovasertib as neoadjuvant and adjuvant therapy in primary uveal melanoma (UM) patients. Treatment with darovasertib as a neoadjuvant therapy provides an opportunity to save the patient's eye by avoiding enucleation or to reduce the tumor in the eye and enable treatment with less radiation to preserve vision. As an adjuvant therapy, the goal is to potentially extend recurrence free survival," said Sreenivasa R. Chandana, M.D., Ph.D., Medical Oncologist at The Cancer & Hematology Centers in Grand Rapids, Michigan, and an investigator of the Phase 2 clinical trial.

IDEAYA's Phase 2 clinical trial, designated as IDE196-009 (NCT05907954), is evaluating darovasertib as monotherapy in (neo)adjuvant uveal melanoma with potential near-term clinical neoadjuvant endpoints such as eye preservation for large ocular tumors and reduction in radiation dose and/or vision preservation for small or medium ocular tumors. Pursuant to the clinical protocol, neoadjuvant treatment of primary UM patients will occur prior to a standard-of-care primary interventional treatment - typically enucleation or radiation therapy. In the adjuvant setting, each of the two neoadjuvant cohorts will be treated with single-agent darovasertib for up to six months as follow-up adjuvant therapy after the primary interventional treatment.

The adjuvant endpoints for this portion of the clinical trial include recurrence free survival and useful vision. IDEAYA plans to enroll patients in the company-sponsored Phase 2clinical trial at clinical sites in the United States, Canada, Europe and Australia. This clinical trial supplements and expands the scope of the ongoing investigator-sponsored Phase 1 clinical trial (IST) in Australia captioned as "Neoadjuvant /Adjuvant trial of Darovasertib in Ocular Melanoma" (NADOM).

The NADOM trial is 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. IDEAYA plans to present an update of clinical data update in the fourth quarter of 2023 from the ongoing NADOM IST evaluating darovasertib As neoadjuvant therapy in primary UM.

The FDA has designated darovasertib as an Orphan Drug in uveal melanoma, including primary and metastatic disease under 21 C.F.R Part 316.