Amgen Reports Positive Data From Phase 1 Study Of Lumakras Combination In Non-small Cell Lung Cancer

(RTTNews) - Amgen (AMGN) announced positive 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 or NSCLC.

The results were featured in an oral presentation at the International Association for the Study of Lung Cancer 2023 World Conference on Lung Cancer (WCLC) in Singapore on September 10.

In patients treated in the first-line setting, the confirmed objective response rate (ORR) was 65%, with a 100% disease control rate or DCR.

In assessable patients in the second-line setting, the objective response rate was 54%, with a disease control rate of 85%. 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.

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.

Amgen noted that it 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, with enrollment expected to start before the end of 2023.

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