Lumakras receives approval in Japan for patients with KRAS G12C mutated advanced NSCLC.

The approval by the Japan Ministry of Health, Labour and Welfare (MHLW) is based on positive results from the Phase II CodeBreaK 100 clinical trial in NSCLC, the largest trial conducted to date for patients with the KRAS G12C mutation. Based on the approved label in Japan, Lumakras 960 mg, orally administered once-daily, demonstrated an objective response rate (ORR) of 37% (95% CI: 28.8-46.6) in 123 evaluable patients (including 10 Japanese patients with a data cutoff date: Sept. 1, 2020). Adverse reactions were observed in 128 (67%) of 190 patients (including 13 Japanese patients). The most common adverse reactions (incidence greater than 5%) were diarrhea (28%), nausea, increased alanine aminotransferase (ALT) and increased aspartate aminotransferase (AST) (16% each), fatigue (11%), increased blood alkaline phosphatase (8%), vomiting (7%) and abdominal pain (5%).

Results from the Phase II CodeBreaK clinical trial in NSCLC were published in The New England Journal of Medicine. (previously cited)