Amgen Launches Phase III CodeBreaK 202 Trial of Lumakras vs. Keytruda in First-Line NSCLC

On June 27, a Phase III clinical trial (CodeBreaK 202) conducted by Amgen was registered on the clinicaltrials.gov website. It aims to evaluate the efficacy and safety of sotorasib (brand name: Lumakras) combined with chemotherapy compared to pembrolizumab (Keytruda) combined with chemotherapy as a first-line treatment for patients with stage IV or stage IIIB/C non-squamous non-small cell lung cancer (NSCLC).

This study is a multicenter, randomized, open-label clinical trial, planning to enroll 750 patients.PD-L1 Negative and KRAS p.G12C Positivepatients with non-squamous NSCLC. The primary endpoint of the study is progression-free survival (PFS). The study is expected to commence in September 2023 and be completed in November 2030.

Sotorasib is a KRAC G12C inhibitor jointly developed by Carmot Therapeutics and Amgen. It was approved for marketing by the FDA in May 2021 based on the positive data from the Phase III CodeBreaK 200 study, forSecond-line TreatmentNSCLC patients carrying the KRAS G12C mutation. The CodeB reaK 200 study included NSCLC patients whose disease progressed after receiving PD-1/PD-L1 drug treatment. This time, Amgen directly initiated a challenge of sotorasib against Keytruda. For a product that has not yet truly stabilized its foundation, the challenge is significant. However, if successful, the rewards will be substantial. One point of concern, though, is that Keytruda is only approved for the treatment of PD-L1 positive NSCLC...

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