Amgen meets key goal for Lumakras in late-stage lung cancer trial
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Amgen (NASDAQ:AMGN) announced Tuesday that the company's KRAS G12C inhibitor Lumakras met the primary endpoint over the standard of care chemotherapy with statistical significance in a late-stage trial for non-small cell lung cancer (NSCLC).
The global Phase 3 CodeBreaK 200 trial was designed to evaluate the once-daily oral therapy in 345 patients with KRAS G12C-mutated NSCLC who had received prior cancer therapy in the form of platinum-based doublet chemotherapy and checkpoint inhibitor therapy.
Citing topline data, AMGN said that the randomized trial met the primary endpoint of progression-free survival (PFS) compared to standard of care chemotherapy, intravenous docetaxel.
"Further analyses of the data are ongoing, and we look forward to sharing detailed data at an upcoming medical meeting," noted David M. Reese, Amgen's (AMGN) executive vice president of R&D.
In May 2021, the FDA approved LUMAKRAS, also known as sotorasib for adults with NSCLC sending the shares of AMGN and rival Mirati Therapeutics (MRTX) higher.
The authorization granted under FDA's accelerated approval was based on overall response rate (ORR) and duration of response (DOR), and the company requires to show the drug's benefit in confirmatory trials for continued approval.