Phase III results for Giotrif (afatinib) in lung cancer published in Lancet Oncology- Boehringer Ingelheim

Boehringer Ingelheim announced that The Lancet Oncology has published results from the LUX-Lung 8 trial (NCT01523587) of Giotrif (afatinib) in squamous cell carcinoma. LUX-Lung 8 is the largest prospective Phase III head-to-head trial directly comparing two EGFR-directed treatments. Afatinib was tested versus erlotinib (Tarceva), an approved and recommended treatment in this setting according to international guidelines, in advanced squamous cell carcinoma (SCC) of the lung progressing after treatment with first-line platinum-based chemotherapy.

The study showed that treatment with afatinib, an irreversible ErbB-family blocker, resulted in superior progression-free survival (PFS, primary endpoint) and overall survival (OS, key secondary endpoint) compared to erlotinib in this patient population. In an updated PFS analysis performed at the time of the OS analysis, patients treated with afatinib had a median PFS of 2.6 months compared to 1.9 months for erlotinib. More patients reported an improvement in overall wellbeing/quality of life with afatinib compared to erlotinib and the rate of severe adverse events was similar between the two treatment arms, with differences observed in the incidence of certain adverse events.

Comment: Afatinib is approved in a number of markets, including the EU, Japan, Taiwan and Canada under the brand name Giotrif, and in the USA under the brand name Gilotrif, for use in patients with distinct types of EGFR mutation-positive NSCLC. Afatinib is under regulatory review by health authorities in other countries worldwide. Afatinib is not approved in other indications.