Lumykras receives positive CHMP opinion for treatment of patients with KRAS G12C-mutated advanced non-small cell lung cancer.-Amgen

If the European Commission follows the recommendation for approval, Lumykras will be the first targeted therapy available in the European Union (EU) for the KRAS G12C mutation, one of the most prevalent biomarkers in NSCLC.

The CHMP based its positive opinion on results from the Phase II CodeBreaK 100 clinical trial, the largest trial conducted to date exclusively for patients with the KRAS G12C mutation. CodeBreaK 100 enrolled 126 patients, 124 of whom had centrally evaluable lesions at baseline. In the trial, Lumykras demonstrated favorable efficacy and tolerability in these 124 patients with KRAS G12C mutation-positive NSCLC who had disease progression after receiving an immunotherapy and/or chemotherapy. Lumykras 960 mg, administered orally once-daily, demonstrated an objective response rate (a proportion of patients with greater than 30% decrease in the sum of the longest diameter of the target lesions compared with baseline) of 37.1% (95% CI: 28.6-46.2) a median duration of response (DoR) of 11.1 months, disease control rate (DCR) of 80.6% and median overall survival (OS) of 12.5 months.