Phase III data shows dose adjustments for Gilotrif (afatinib) in non-small cell lung cancer reduces adverse events but not efficacy- Boehringer

Results from a new post-hoc analysis of two large Phase III trials (LUX-Lung 3 and LUX-Lung 6) assessing the impact of dose adjustments for Gilotrif (afatinib), from Boehringer, in patients with advanced non-small cell lung cancer (NSCLC) suggests specific dose reductions led to decreases in the incidence and severity of treatment-related adverse events (AEs) in afatinib-treated patients without any apparent compromise in efficacy.

Afatinib-treated patients from the LUX-Lung 3 [NCT00949650] (n=229) and LUX-Lung 6 [NCT01121393] (n=239) trials were included in the analysis. Dose reductions took place in 53.3% (n=122) and 28% (n=67) of patients in each study, respectively, most within the first six months of treatment. Dose reductions were associated with decreases in the incidence and severity of treatment-related AEs, while median progression-free survival (PFS) was similar in patients who dose-reduced within the first six months of treatment versus those who did not (LUX-Lung 3, 11.3 vs 11 months; LUX-Lung 6, 12.3 vs 11 months). Data were published in Annals of Oncology.

Comment: This further analysis suggests that dosing of afatinib can be adjusted to help manage a patient's treatment-related adverse events, without any apparent reduction in efficacy. Afatinib is approved in over 70 countries for the first-line treatment of EGFR mutation-positive NSCLC. Approval of afatinib in this indication was based on the primary endpoint of PFS from the LUX-Lung 3 clinical trial.