Boehringer Ingelheim's Gilotrif demonstrated superiority to Iressa

Results of global Phase IIb LUX-Lung 7 trial demonstrate afatinib is superior in reducing the risk of lung cancer progression and the risk of treatment failure both by 27% compared to gefitinib.

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 tumour response (a clinically meaningful decrease in tumour 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.

"As the first global head-to-head trial directly comparing two EGFR-directed therapies for the treatment of patients with EGFR mutation-positive NSCLC, LUX-Lung 7 marks a significant milestone to better understanding the benefits of first-line treatment options for this population," said Shirish Gadgeel, leader of the Thoracic Oncology Multidisciplinary Team and president of the Medical Executive Committee of the Karmanos Cancer Center, Detroit. "The study showed that afatinib demonstrated superiority to gefinitib as measured by progression free survival and time to treatment failure - important findings that should factor into how EGFR mutation-positive patients are treated."

Adverse events (AEs) observed in the LUX-Lung 7 trial were consistent with the known safety profiles of both treatments. Treatment with both afatinib and gefitinib was generally tolerable, leading to an equally low rate of treatment-related discontinuation in both arms (6.3%). The overall frequency of serious AEs was similar for both (afatinib: 44.4% vs gefitinib: 37.1%); the most common grade >=3 related AEs with afatinib were diarrhea (12.5%) and rash/acne (9.4%), and with gefitinib aspartate aminotransferase (AST)/alanine aminotransferase (ALT) increase (8.8%) and rash/acne (3.1%). Drug-related interstitial lung disease was reported in four patients on gefitinib and no patients on afatinib.

"LUX-Lung 7 is the second positive head-to-head trial of afatinib versus first-generation EGFR TKIs in lung cancer, showing that first- and second-generation EGFR targeted agents are not the same," said Dr Mehdi Shahidi, Medical Head, Solid Tumor Oncology, Boehringer Ingelheim. "Interestingly, the progression-free survival difference observed in the LUX-Lung 7 trial became more prominent over time so that the progression-free survival rate was more than doubled with afatinib at 24 months."