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IDEAYA Announces Results for Darovasertib Phase 2 IST in Neoadjuvant Uveal Melanoma at ASCO and Clinical Update for Phase 2 Company-Sponsored Neoadjuvant Study
75% eye preservation rate (9 of 12 enucleation patients)~67% (8 of 12 enucleation patients) observed greater than 30% tumor shrinkage and median tumor
About this update from Ideaya Biosciences, Inc.
[{"type":"text","content":"75% eye preservation rate (9 of 12 enucleation patients)~67% (8 of 12 enucleation patients) observed greater than 30% tumor shrinkage and median tumor shrinkage of 47% by volume change after 6 monthsCompany-sponsored Phase 2 Neoadjuvant UM: Over 40 patients enrolled, and for the 8 patients with ≥4-months of darovasertib observed median tumor shrinkage of 72% by volume change and eye preserved for the majority of enucleation patientsTargeting Type C meeting with the FDA in H2 2024 for guidance on potential registrational trial for darovasertib in neoadjuvant UM settingProjected global annual incidence of primary UM is ~8,000 to ~10,000 patientsSOUTH SAN FRANCISCO, Calif., June 3, 2024 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, today announced updated clinical results from the ongoing investigator-sponsored Phase 2 trial of darovasertib, a first-in-class oral, small molecular inhibitor of protein kinase C (PKC), as neoadjuvant/adjuvant treatment in uveal melanoma (UM) and clinical update for Phase 2 company-sponsored neoadjuvant UM study. The clinical data from the ongoing investigator-sponsored Phase 2 trial were included in an oral presentation at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting.\n\n \n \n \n \n \n \n\n \n\"The clinical data presented at ASCO provides further validation for the potential of darovasertib in the neoadjuvant UM setting to preserve the eye and to shrink ocular tumors for UM patients,\" said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences. \"We believe neoadjuvant and adjuvant UM represent high unmet medical needs and indication expansion opportunities that are potential first-line treatment opportunities across the patient journey and irrespective of HLA-A2 status that will significantly expand the addressable patient population for darovasertib beyond the metastatic setting.\"\n\"The clinical data presented at ASCO highlights the potential of darovasertib as a neoadjuvant treatment to provide meaningful tumor shrinkage in patients with ocular tumors and spare patients from enucleation, with a manageable AE profile,\" added Darrin Beaupre, M.D., Ph.D., Chief Medical Officer, IDEAYA Biosciences. \"We are targeting a Type C meeting with ...