On October 17, 2023 IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported the publication of the abstract for a proffered paper session at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023 (ESMO 2023) relating to selected clinical data from the company’s ongoing Phase 2 clinical trial evaluating darovasertib in combination with crizotinib in patients having metastatic uveal melanoma (MUM) (Press release, Ideaya Biosciences, OCT 17, 2023, View Source [SID1234636087]).
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Dr. Meredith McKean, M.D., MPH, Director, Melanoma and Skin Cancer Research at Sarah Cannon Research Institute, who is a clinical investigator on the Phase 2 clinical trial, will present the clinical data as summarized in the abstract, as follows:
Session No. 1081O
Title: ctDNA reduction and clinical efficacy of the darovasertib + crizotinib (Daro + Crizo) combination in metastatic uveal melanoma (MUM)
Date: Monday, October 23, 2023 at 8:50-9:00 am CEST
Dr. Meredith McKean, M.D., MPH, Sarah Cannon Research Institute (Nashville, TN, U.S.A)
In summary, the Phase 2 evaluation of the darovasertib and crizotinib combination in first-line and pretreated MUM patients showed a manageable safety profile and demonstrated clinical efficacy that appears superior to current standards of care. Human leukocyte antigen (HLA)-A*02:01 (HLA-A2) status was determined in a subset of patients enrolled in the company’s clinical trials evaluating darovasertib. Clinical efficacy was observed in both HLA-A2 positive (HLA-A2(+)) and HLA-A2 negative (HLA-A2(-)) patients. ctDNA was reduced in almost all patients and ctDNA molecular responses were deep and sustained in the majority of patients.
The reported data support IDEAYA’s ongoing registrational Phase 2/3 study for potential accelerated approval of darovasertib and crizotinib for treatment of first-line HLA-A2(-) MUM patients, where there are no FDA approved therapies.
A press release summarizing the top-line results will be available on Monday, October 23, 2023, at approximately 6:00 am ET, and will be available on the Company’s website, at its Investor Relations portal (View Source).