Journal article
Single-Agent Divarasib (GDC-6036) in Solid Tumors with a KRAS G12C Mutation.
A Sacher, P Lorusso, MR Patel, WH Miller, E Garralda, MD Forster, A Santoro, A Falcon, TW Kim, L Paz-Ares, S Bowyer, M De Miguel, SW Han, MG Krebs, JS Lee, ML Cheng, K Arbour, E Massarelli, Y Choi, Z Shi Show all
New England Journal of Medicine | Published : 2023
Abstract
Background Divarasib (GDC-6036) is a covalent KRAS G12C inhibitor that was designed to have high potency and selectivity. Methods In a phase 1 study, we evaluated divarasib administered orally once daily (at doses ranging from 50 to 400 mg) in patients who had advanced or metastatic solid tumors that harbor a KRAS G12C mutation. The primary objective was an assessment of safety; pharmacokinetics, investigator-evaluated antitumor activity, and biomarkers of response and resistance were also assessed. Results A total of 137 patients (60 with non-small-cell lung cancer [NSCLC], 55 with colorectal cancer, and 22 with other solid tumors) received divarasib. No dose-limiting toxic effects or treat..
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Awarded by 'la Caixa' Foundation
Funding Acknowledgements
Supported by Genentech. Dr. Garralda is supported by Caixa-Research Advanced Oncology Research Program, Fundacio La Caixa (LCF-PR-CE07-50610001). Dr. Forster is supported by the UCL-UCLH NIHR Biomedical Research Centre and runs early phase studies in the NIHR UCLH Clinical Research Facility supported by the UCL ECMC. Dr. Krebs acknowledges support by the National Institute of Health Research (NIHR) Manchester Biomedical Research Centre, NIHR Manchester Clinical Research Facility at the Christie and Manchester Experimental Cancer Medicine Centre (Manchester, UK).