Amgen CodeBreaK 101 Study Results

Amgen (NASDAQ:AMGN) today announced exciting data from a study arm of the CodeBreaK 101 clinical trial, a Phase 1b study evaluating LUMAKRAS® (sotorasib) with carboplatin and pemetrexed in adult patients with KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC). These results were featured in an oral presentation at the International Association for the Study of Lung Cancer (IASLC) 2023 World Conference on Lung Cancer (WCLC) in Singapore on Sunday, September 10.

In patients treated in the first-line setting (n=20), the confirmed objective response rate (ORR) was 65%, with a 100% disease control rate (DCR) (95% CI: 83.2, 100). In assessable patients in the second-line setting (n=13), the ORR was 54%, with a DCR of 85% (95% CI: 54.6, 98.1). Among patients with protein ligand-1 (PD-L1) expression less than 1%, the ORR was 62% in the first-line setting and 50% in the second-line setting. With a median follow-up of 3.0 months, preliminary rapid and durable responses were observed. Progression-free survival (PFS) and overall survival (OS) were immature.

“We are delighted to see the positive data from the global CodeBreaK 101 trial further validate our approach to move LUMAKRAS earlier within the treatment paradigm through novel therapeutic combinations,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “Notably, these results follow and further expand upon the Phase 2 investigator-led data demonstrating favorable efficacy and safety of LUMAKRAS plus carboplatin and pemetrexed in the first-line treatment of patients with KRAS G12C-mutated NSCLC.”

The LUMAKRAS plus chemotherapy combination reported treatment-related adverse events (TRAEs) consistent with LUMAKRAS and other platinum doublet-based approaches. The most common TRAEs were neutropenia/neutrophil count decrease (53%), anemia (39%) and thrombocytopenia/platelet count decrease (37%). No fatal adverse events occurred.

“Combination treatment is an important approach to prevent or delay the onset of drug resistance and improve the depth and durability of targeted response in KRAS G12C­­-mutated NSCLC,” said Jeffrey M. Clarke, M.D., oncologist and associate professor of medicine, Duke Cancer Institute at Duke University. “The CodeBreaK 101 results show exciting efficacy with sotorasib plus chemotherapy and, importantly for a combination treatment, a safety profile consistent with the individual therapies. These data warrant continued investigation in larger trials.”

Based on these results, Amgen has initiated a Phase 3 study of LUMAKRAS plus carboplatin and pemetrexed in first-line KRAS G12C-mutant and negative for programmed cell death PD-L1 advanced NSCLC (CodeBreaK 202; NCT05920356), with enrollment expected to start before the end of 2023.


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