Amgen (AMGN) Reports Phase 3 CodeBreaK 200 trial of Lumakras Met Primary Endpoint

Amgen (NASDAQ: AMGN) today announced that the global Phase 3 CodeBreaK 200 trial evaluating once daily oral LUMAKRAS® (sotorasib) met its primary endpoint of progression-free survival (PFS), demonstrating statistical significance and superiority over standard of care chemotherapy, intravenous docetaxel. The first randomized clinical trial for a KRASG12C inhibitor assessed the efficacy and safety of LUMAKRAS in 345 previously treated patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC) who had received at minimum, prior platinum-based doublet chemotherapy and checkpoint inhibitor therapy.

"Further analyses of the data are ongoing, and we look forward to sharing detailed data at an upcoming medical meeting," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "We are grateful to all of the investigators and patients who participated in this first randomized, controlled clinical trial of a KRASG12C inhibitor."

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