Sotorasib for Lung Cancers with <i>KRAS</i> p.G12C Mutation
Ferdinandos Skoulidis, Bob T. Li, Grace K. Dy, Timothy Price, Gerald S. Falchook, Jürgen Wolf, Antoîne Italiano, Martin Schüler, Hossein Borghaei, Fabrice Barlési, Terufumi Kato, Alessandra Curioni‐Fontecedro, Adrian G. Sacher, Alexander I. Spira, Suresh S. Ramalingam, Toshiaki Takahashi, Benjamin Besse, Abraham Anderson, Agnes Ang, Qui Tran, Omar Mather, Haby Henary, Gataree Ngarmchamnanrith, Gregory Friberg, Vamsidhar Velcheti, Ramaswamy Govindan
Abstract
BACKGROUND: p.G12C-mutated advanced solid tumors in a phase 1 study, and particularly promising anticancer activity was observed in a subgroup of patients with non-small-cell lung cancer (NSCLC). METHODS: p.G12C-mutated advanced NSCLC previously treated with standard therapies. The primary end point was objective response (complete or partial response) according to independent central review. Key secondary end points included duration of response, disease control (defined as complete response, partial response, or stable disease), progression-free survival, overall survival, and safety. Exploratory biomarkers were evaluated for their association with response to sotorasib therapy. RESULTS: . CONCLUSIONS: p.G12C-mutated NSCLC. (Funded by Amgen and the National Institutes of Health; CodeBreaK100 ClinicalTrials.gov number, NCT03600883.).