IDEAYA 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).
“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 trial.