Sotorasib demonstrated positive topline Phase 2 results in the CodeBreaK 100 clinical study among 126 patients with KRAS G12C-mutant advanced non-small cell lung cancer, who had failed a median of two prior lines of anti-cancer therapies. 

Treatment with sotorasib showed an objective response rate consistent with previous Phase 1 data in patients with advanced NSCLC taking the 960 mg daily dose, according to a press release. Additionally, the safety and tolerability data were similar to the Phase 1 results. 

Duration of response was also promising, according to the company, with more than half of the responders remaining on treatment and continuing to respond at the cutoff date. 

"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," David M. Reese, MD, EVP of Research and Development, Amgen, said in the release. 

The company is submitting detailed results from this phase II to the IASLC 2020 World Congress on Lung Cancer taking place in January. 

“We look forward to discussing the current results with the U.S. Food and Drug Administration 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," David M. Reese, MD, continued in the release. 

A global Phase 3 (CodeBreaK 200) has begun recruiting for a randomized active-controlled confirmatory study comparing sotorasib to docetaxel in KRAS G12C-mutant NSCLC patients. 

 
By MD /alert Staff