Amgen announced positive topline Phase 2 results from the CodeBreaK 100 clinical study, evaluating sotorasib (proposed INN for AMG 510) in 126 patients with KRAS G12C-mutant advanced non-small cell lung cancer (NSCLC), who had failed a median of two prior lines of anti-cancer therapies (immunotherapy and/or chemotherapy).
Sotorasib demonstrated an objective response rate (primary end point) consistent with previously reported Phase 1 data in patients with advanced NSCLC taking the 960 mg daily dose. Other measures of efficacy, including duration of response, were promising and more than half of the responders were still on treatment and continuing to respond as of the data cutoff date. Safety and tolerability were similar to previously reported data in Phase 1 in patients with advanced NSCLC.
“Targeting KRAS has been a 40-year quest that has left patients with limited options. These topline data underscore our belief in the potential for sotorasib to become the standard of care for non-small cell lung cancer patients with the KRAS G12C mutation who remain in need of new treatment options,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “We now have more than 500 patients who have been enrolled across clinical studies, and we are rapidly moving forward with a broad-based development program, which includes monotherapy studies in non-small cell lung cancer, colorectal cancer and other solid tumors harboring the KRAS G12C mutation, as well as a suite of combination studies. We look forward to discussing the current results with the U.S. Food and Drug Administration (FDA) and other regulatory agencies, to determine the best path forward for sotorasib as a potential treatment for patients with NSCLC harboring the KRAS G12C mutation.”
Detailed results of this potentially registrational Phase 2 clinical study in patients with advanced NSCLC will be submitted to the IASLC 2020 World Congress on Lung Cancer taking place January 2021. A global Phase 3 randomized active-controlled confirmatory study comparing sotorasib to docetaxel in KRAS G12C-mutant NSCLC patients (CodeBreaK 200) has begun recruiting.