The findings, from a comparative clinical study on the effects of smoking on the pharmacokinetics of Tarceva (erlotinib) in healthy (non-cancer patients) smokers and non-smokers, built upon observations made from an analysis of Tarceva exposure in patients from the drug’s pivotal BR.21 phase III trial.
In the BR.21 trial the effect of Tarceva on survival was observed in both never smokers and smokers, an apparently larger effect was observed in patients who never smoked.
“We believe that effective dosing at or close to the maximum tolerated dose of Tarceva therapy for most lung cancer patients is an important component,” stated Gabe Leung, executive vice president and president of oncology at OSI Pharmaceuticals. “This observation may be of fundamental importance to the optimization of Tarceva treatment in the subset of lung cancer patients who are smokers.”