Business
IDEAYA Announces IDE196 Program Update and Clinical Protocol Criteria Met for Cohort Expansion in Skin Melanoma for Phase 2 GNAQ/11 Basket Trial
- 4 evaluable GNAQ/11 mutation skin melanoma patients enrolled in Stage 1 cohort with a 100% Disease Control Rate (excluding 1 non-evaluable) and 1 confirmed
About this update from Ideaya Biosciences, Inc.
[{"type":"text","content":"- 4 evaluable GNAQ/11 mutation skin melanoma patients enrolled in Stage 1 cohort with a 100% Disease Control Rate (excluding 1 non-evaluable) and 1 confirmed partial response by RECIST 1.1 guidelines\n - 15 additional skin melanoma patients harboring GNAQ/11 mutations will be enrolled in Stage 2 of cohort expansion in Phase 2 GNAQ/11 basket arm of the clinical trial\n - Dosed first leiomyosarcoma patient in the Phase 2 GNAQ/11 basket arm, expanding the tissue-agnostic approach to additional solid tumors\n - IDE196 tablet formulation complete and successfully introduced in ongoing clinical trial, including the IDE196-binimetinib combination arm and the GNAQ/11 basket arm\n - 13-week preclinical toxicology studies in 2 species are now complete with receipt of submission-ready audited draft reports\n\n\nSOUTH SAN FRANCISCO, Calif., July 16, 2020 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics, announced that it has met the clinical protocol criteria for cohort expansion in the cutaneous (skin) melanoma cohort of its Phase 2 basket arm evaluating IDE196 monotherapy in solid tumors harboring GNAQ or GNA11 hotspot mutations (GNAQ/11). \n\n \n \n \n \n \n \n\n \nIDEAYA has enrolled 4 evaluable and 1 non-evaluable skin melanoma patients harboring GNAQ/11 mutations in an initial Stage 1 cohort of the study design. Pursuant to the protocol, if no RECIST (Response Evaluation Criteria in Solid Tumors) responses are observed in the targeted 9 patients of Stage 1 cohort, no additional expansion patients are to be enrolled in that cohort; otherwise, a second Stage 2 of enrollment comprising of 15 additional patients may be enrolled for a total of 24 patients. The 1 confirmed partial response in a GNAQ/11 mutation skin melanoma patient was determined by RECIST guidelines (version 1.1). \n\"I am pleased IDE196 has met the criteria for Stage 2 expansion in skin melanoma, as these patients with GNAQ/11 mutations may not have actionable BRAF driver mutations and may also have a low tumor mutational burden, and thus be less responsive to existing treatment options,\" said Marlana Orloff, M.D., Assistant Professor at Thomas Jefferson University Hospital in Philadelphia, who is a Principal Investigator on the IDEAYA clinical tria...