IDEAYA Biosciences Inc, 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 tumours harbouring GNAQ or GNA11 hotspot mutations (GNAQ/11).
IDEAYA has enrolled 4 evaluable and 1 non-evaluable skin melanoma patients harbouring 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 Tumours) 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 tumour 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.
IDEAYA continues to monitor COVID-19 and its potential impact on clinical trials and timing of clinical data results. COVID-19 infection rates have increased over the last weeks in several states in which our enrollment sites are located.
Based on the increased target enrollment and potential impact of the COVID-19 pandemic, further IDE196 monotherapy interim data is anticipated to be in the first half of 2021.
“IDE196 expansion in skin melanoma enables IDEAYA to build a larger data set and to explore potential combinations in this tumor type, and further validates our GNAQ/11 tissue-agnostic approach,” said Mick O’Quigley, vice president, head of Development Operations at IDEAYA Biosciences.
