- Amgen Inc AMGN announced results from two analyses of the Phase 2 CodeBreaK 100 trial evaluating Lumakras (sotorasib).
- Lumakras, a KRASG12C inhibitor, is approved in the U.S. for previously treated patients with advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC).
- Related Content: Amgen's First KRAS-Targeted Therapy, Lumakras Scores FDA Approval For Lung Cancer.
- In a post-hoc analysis of 40 patients, Lumakras achieved a 77.5% disease control rate (DCR), similar to patients without brain metastases.
- A median progression-free survival (PFS) of 5.3 months and median overall survival (OS) of 8.3 months were observed.
- In patients evaluable by Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria, 14 of 16 patients (88%) maintained intracranial disease control of their stable brain lesions during Lumakras therapy with two achieving complete responses of non-target lesions.
- The safety profile of Lumakras in the brain metastases group was consistent with previous reports.
- Amgen is enrolling patients with active brain metastases in an arm of the CodeBreaK 101 study.
- Price Action: AMGN stock is down 0.41% at $219.97 during the premarket session on the last check Thursday.
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