(Lung Cancer) Is LUMAKRAS Effective?
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On August 30, 2022, Amgen announced in a press release the results of the Phase 3 CodeBreaK 200 clinical trial evaluating the efficacy and safety of LUMAKRAS monotherapy in patients with KRAS G12C-mutated, locally advanced or unresectable non-small cell lung cancer (NSCLC).
CodeBreaK 200 is a randomized Phase 3 trial conducted across multiple international facilities. Patients with KRAS G12C-mutated, locally advanced or unresectable NSCLC (N=345) were randomized to either the LUMAKRAS group (administered once daily in 21-day cycles) or the docetaxel group (administered in 21-day cycles). The primary endpoint was progression-free survival (PFS), with secondary endpoints including overall survival (OS) and objective response rate (ORR).
The trial results showed that the LUMAKRAS group achieved a statistically significant improvement in the primary endpoint of progression-free survival compared to the docetaxel group, meeting the study's pre-specified goal.
Based on the CodeBreaK 200 trial results, David M. Reese stated that a comprehensive analysis of the CodeBreaK 200 trial is currently underway and will be presented at a future medical conference.
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