Boehringer Ingelheim announced The Lancet Oncology has published results from the LUX-Lung 8 trial (NCT01523587). LUX-Lung 8 is the largest, prospective Phase III head-to-head trial directly comparing two EGFR-directed treatments. Afatinib* was tested versus erlotinib, 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. Treatment options for SCC of the lung are limited and this type of lung cancer is associated with a poor prognosis, with less than 5% of patients with advanced SCC surviving for five years or longer.
While afatinib is not yet approved for use in patients with SCC, 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.
Previously reported data demonstrated that the LUX-Lung 8 study met its primary endpoint as afatinib significantly improved PFS compared to erlotinib. In addition, afatinib extended OS of patients to a median of 7.9 months compared to 6.8 months on erlotinib, reducing the risk of death by 19%. 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 well-being/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.
Afatinib is approved in a number of markets, including the EU, Japan, Taiwan and Canada under the brand name GIOTRIF® and in the US under the brand name GILOTRIF® for use in patients with distinct types of EGFR mutation-positive NSCLC. Registration conditions differ internationally, please refer to locally approved prescribing information. Afatinib is under regulatory review by health authorities in other countries worldwide. Afatinib is not approved in other indications.
