Business
IDEAYA Announces First-Patient-In for Company-Sponsored Phase 2 Clinical Trial Evaluating Darovasertib in (Neo)Adjuvant Uveal Melanoma
Dosed a first patient in a company-sponsored global Phase 2 clinical trial evaluating darovasertib as neoadjuvant and adjuvant therapy in primary uveal
About this update from Ideaya Biosciences, Inc.
[{"type":"text","content":"Dosed a first patient in a company-sponsored global Phase 2 clinical trial evaluating darovasertib as neoadjuvant and adjuvant therapy in primary uveal melanoma (UM)Preliminary clinical activity observed in primary UM, including tumor shrinkage in 9 of 9 patients following neoadjuvant therapy with darovasertib as monotherapy or in combination with crizotinib, two of whom were spared enucleation and preserved visionTargeting clinical data update in the fourth quarter of 2023 from the ongoing NADOM IST evaluating single-agent darovasertib as neoadjuvant therapy in primary UM patients(Neo)adjuvant UM has no approved systemic therapies with an annual incidence of ~8,700 patients and estimated prevalence of ~100,000 patients aggregate in the U.S. and EuropeSOUTH SAN FRANCISCO, Calif., Aug. 16, 2023 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, 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. \n\n \n \n \n \n \n \n\n \n\"We are excited to dose our first patient in this Phase 2 clinical trial. Our recently reported preliminary clinical data in the neoadjuvant setting showed compelling evidence of anti-tumor activity – with observed tumor shrinkage in 9 patients, including two patients who were able to avoid enucleation. These data support further clinical evaluation of darovasertib to determine its potential as a neoadjuvant and adjuvant therapy,\" said Dr. Darrin Beaupre, Chief Medical Officer, IDEAYA Biosciences. \n\"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. \nIDEAYA'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 ne...