Studies confirm safety and efficacy of Giotrif (Boehringer) in NSCLC

Data from two pivotal large-scale Phase III registration studies of Giotrif (afatinib), from Boehringer, LUX-Lung 3 and LUX-Lung 6, showed superior efficacy and a manageable safety profile in both Asian and non-Asian Non Small Cell Lung Cancer patients compared to chemotherapy. The new pooled safety analysis substantiates afatinib�s previously reported adverse events (AEs) and tolerability profile in Asian and non-Asian EGFR mutation positive NSCLC patients. The most common grade 3 side effects which occurred at a similar rate in both patient groups were diarrhoea, rash/acne and stomatitis. There was also no difference in the afatinib pharmacokinetic exposure between the two patient populations.

In addition, the largest data series to date of efficacy in patients with uncommon EGFR mutations pooled from three prospective clinical trials shows that the activity of afatinib in certain types of rare EGFR mutations is in the same range as demonstrated for common EGFR mutations (deletion 19, L858R) patient. Results were presented at the World Conference on Lung Cancer.