Amgen has announced that its phase 3 trial evaluating once daily oral Lumakras (sotorasib) met its primary endpoint of progression-free survival, demonstrating ‘statistical significance and superiority’ over standard of care Docetaxel chemotherapy in KRAS G12C-mutated non-small cell lung cancer (NSCLC).
The phase 3 CodeBreaK 200 trial assessed the safety and efficacy of Lumakras in 345 previously treated patients with KRAS G12C-mutated NSCLC who had received at minimum, prior platinum-based doublet chemotherapy and checkpoint inhibitor therapy.
The exact details of the study remains sparse, with the company outlining its plans to present detailed data at an upcoming medical congress.
Amgen has not yet shared any information on whether Lumakras improved overall survival, a key secondary endpoint of the study. The company did however release results from the CodeBreaK 100 phase 1/2 trial in patients with KRAS G12C-mutated advanced NSCLC in April, which demonstrated a two year overall survival of 32.5% in patients treated with Lumakras.
Lung cancer is the leading cause of cancer-related deaths worldwide, accounting for more deaths worldwide than colon cancer, breast cancer and prostate cancer combined. Though overall survival rates for NSCLC are improving, the outlook for patients with advanced disease remains poor, and five year survival is only 8% for those with metastatic disease.
KRAS G12C is the most common KRAS mutation in NSCLC, with around 13% of patients with NSCLC harbouring the KRAS G12C mutation. Treatment options are limited for NSCLC patients with the KRAS G12C mutation whose first-line treatment has failed to work or has stopped working, and the outcomes with other approved therapies are suboptimal, Amgen reported.
David Reese, executive vice president of Research and Development at Amgen, said: “Further analyses of the data are ongoing, and we look forward to sharing detailed data at an upcoming medical meeting.
“We are grateful to all of the investigators and patients who participated in this first randomised, controlled clinical trial of a KRAS inhibitor.”
In May 2021, Lumakras was the first KRAS G12C inhibitor to receive regulatory approval with its approval by the US Food and Drug Administration (FDA). The treatment was also approved by the European Commission (EC) for this same indication in January, and is approved in over 44 markets around the world.