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Phase III data published in The Lancet Oncology shows a significant overall survival benefit of Giotrif® (afatinib) compared to Tarceva® (er

INGELHEIM, Germany - Monday, July 6th 2015 [ME NewsWire]

(BUSINESS WIRE)-- Phase III data published in The Lancet Oncology shows a significant overall survival benefit of Giotrif® (afatinib) compared to Tarceva® (erlotinib) in patients with previously treated advanced squamous cell carcinoma of the lung

Boehringer Ingelheim today 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.

Dr. Mehdi Shahidi, Medical Head, Solid Tumour Oncology, Boehringer Ingelheim commented: “The ErbB family of receptors plays an important role in the development of squamous cell carcinoma of the lung, and is a valid therapeutic target for this type of cancer. The broader and irreversible ErbB blockade of afatinib may explain the superiority shown in LUX-Lung 8 over erlotinib, an EGFR inhibitor already approved in this setting. We are pleased with the publication of LUX-Lung 8 data in The Lancet Oncology and based on the improvement in overall survival with the use of afatinib, we are in the process of preparing regulatory submissions.”

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. See the online publication for full details.

*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.

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This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

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