Amgen Announces Positive Interim Data from CodeBreaK 100 Trial of Sotorasib in Patients with KRAS G12C-Mutated Advanced Non-Small Cell Lung Cancer

Amgen Announces Positive Interim Data from CodeBreaK 100 Trial of Sotorasib in Patients with KRAS G12C-Mutated Advanced Non-Small Cell Lung Cancer

Amgen announced results from the Phase 2 cohort of the CodeBreaK 100 study evaluating sotorasib (AMG 510) in 126 patients with KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC). The results will be presented during the Presidential Symposium at the International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer (WCLC). 

CodeBreak 100 is a phase 1/2 open-label multicenter study enrolling patients with KRAS G12C-mutant solid tumors. Eligible patients must have received a prior line of systemic anticancer therapy, consistent with their tumor type and stage of disease. The primary endpoint for the Phase 2 portion of the study is centrally assessed objective response rate. The Phase 2 portion in NSCLC enrolled 126 patients, 124 of whom had centrally evaluable lesions by RECIST at baseline. Patients were treated with sotorasib 960 mg once daily orally. Prior to the trial, 81% of patients had progressed on both platinum-based chemotherapy and PD1/L1 inhibitors, with the remainder progressing after having received one of these therapies. A separate cohort of patients with colorectal cancer (CRC) is fully...

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