Press release
AMGEN PRESENTS NEW LUMAKRAS® (SOTORASIB) PLUS CHEMOTHERAPY DATA IN FIRST-LINE KRAS G12C NSCLC AT WCLC
In Phase 1b Study, Patients Treated in First-Line Demonstrated a Confirmed Objective Response Rate of 65% THOUSAND OAKS, Calif., Sept. 10, 2023 /PRNewswire/
About this update from Amgen Inc.
[{"type":"text","content":"In Phase 1b Study, Patients Treated in First-Line Demonstrated a Confirmed Objective Response Rate of 65%\nTHOUSAND OAKS, Calif., Sept. 10, 2023 /PRNewswire/ -- 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.\nIn 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.\n\"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.\"\nThe 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.\n\"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 professo...