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Afatinib* delivers unprecedented first line efficacy in patients with EGFR mutation positive lung cancer in registration trial

LUX-Lung 3 results highlighted at the official ASCO Press Conference: Afatinib* delays cancer progression significantly more than the best standard chemotherapy - For NON-US media only

Ingelheim, Germany, 4 June 2012 –The LUX-Lung 3 Phase III results showed that lung cancer patients taking the novel compound afatinib*, an irreversible ErbB Family Blocker, as a first-line treatment, lived for almost one year before their tumour started to grow again (progression-free survival (PFS) of 11.1 months) versus just over half a year (PFS of 6.9 months) for those on standard chemotherapy (pemetrexed / cisplatin). 1 Importantly, patients taking afatinib* with the most common EGFR mutations (del19 and L858R, accounting for 90% of all EGFR mutations) lived for well over a year without progression (PFS of 13.6 months) versus just over half a year (PFS of 6.9 months) for those in the comparator arm. 1

Boehringer Ingelheim’s registration trial LUX-Lung 3 is investigating the company’s front runner molecule afatinib*, and is the largest and most robust trial to date in EGFR (ErbB1) mutation positive advanced lung cancer patients. The primary endpoint was progression-free survival (PFS).

“Not only did LUX-Lung 3 meet its primary endpoint, but it also showed that afatinib*, especially in patients with the most common EGFR mutations, almost doubled the progression free survival time compared to chemotherapy.” commented Prof. James Chih-Hsin Yang, Director of the Cancer Research Center, College of Medicine, National Taiwan University, Taipei, Taiwan and principal investigator of the LUX-Lung 3 trial. “Based on this proven efficacy in the largest and most robust registration trial, coupled with its novel mode of action, afatinib* may become one of the most valuable treatment options for this distinct patient population.”

The delay in disease progression for afatinib*-treated patients was associated with better control of life-restricting disease-related symptoms 1. More patients taking afatinib* experienced improvement of symptoms such as dyspnea (shortness of breath), cough and chest pain. Afatinib* also delayed the onset of these symptoms 1.

A standard lung cancer questionnaire to assess the quality of life of cancer patients revealed that afatinib* treatment translates into significantly improved quality of life (e.g. at work and during household activities). 1

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