Phase IIb trial of Giotrif (afatinib) in non-small cell lung cancer meets endpoints- Boehringer

Boehringer Ingelheim announced the results of the LUX-Lung 7 trial, a Phase IIb trial of Giotrif (afatinib) in patients with advanced non-small cell lung cancer (NSCLC), has met two of its co-primary endpoints of progression-free survival (PFS) by independent review and time to treatment failure (a measure of time between start, and discontinuation of treatment for any reason). Superiority in progression-free survival and time to treatment failure was demonstrated with second-generation EGFR-directed therapy afatinib versus first-generation gefitinib in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) with common EGFR mutations (del19 or L858R).

Results from the LUX-Lung 7 trial showed that afatinib significantly reduced the risk of lung cancer progression by 27% versus gefitinib. The improvement in PFS became more pronounced over time, with a significantly higher proportion of patients alive and progression-free at 18 months (27% vs 15%) and 24 months (18% vs 8%), showing a greater long-term benefit to using afatinib versus gefitinib. In addition to superior PFS, patients on afatinib had a significantly longer time on treatment: risk of treatment failure was reduced by 27% versus gefitinib. Significantly more patients had an objective tumor response (a clinically meaningful decrease in tumor size) with afatinib when compared to gefitinib (70% vs 56%), with a median duration of response of 10.1 months and 8.4 months, respectively. The improvement in PFS with afatinib was consistent across most pre-defined clinical subgroups, including gender, age, race and EGFR mutation type.

Adverse events (AEs) observed in the LUX-Lung 7 trial were consistent with the known safety profiles of both treatments. The LUX-Lung 7 trial results will be presented at the 14th Annual British Thoracic Oncology Group (BTOG) Conference.