Amgen Announces Positive Topline Results from Phase II CodeBreaK 100 Trial of Sotorasib in Advanced NSCLC

Text | Baihuawen

On October 5, Amgen announced positive topline results from the Phase II CodeBreaK 100 clinical trial of its KRAS G12C inhibitor sotorasib (AMG 510) for the treatment of 126 patients with advanced non-small cell lung cancer (NSCLC) who had previously received immunotherapy and/or chemotherapy.

The study results demonstrated that the objective response rate (ORR) of sotorasib was consistent with previously reported Phase I clinical data (960 mg daily dose group for advanced NSCLC), thereby meeting the primary endpoint. Other efficacy endpoints, including duration of response, were also encouraging; at the data cutoff, more than half of the responding patients remained on treatment and continued to respond. The safety and tolerability profile was consistent with previous findings. Data from this potential Phase II registrational study will be presented at the World Conference on Lung Cancer in January 2021.

David M. Reese, M.D., Executive Vice President of Research and Development at Amgen, stated, “Research into KRAS-mutant patients with limited treatment options has been ongoing for 40 years. The top-line results announced this time indicate that Sotorasib has the potential to become the standard of care for patients with non-small cell lung cancer (NSCLC) harboring KRAS G12C mutations. Currently, more than 500 patients have enrolled in clinical trials, and we are rapidly advancing other clinical development programs, including studies in other solid tumors such as colorectal cancer with KRAS G12C mutations. We look forward to discussing these current results with the FDA to determine next steps.”