Press release New Lux-Lung 1 data December 2010

New subgroup analysis of the LUX-Lung 1 trial suggests benefit from afatinib* in lung cancer patients likely to have EGFR mutations

- Study findings add to the growing clinical evidence for afatinib (BIBW 2992), and support the ongoing LUX clinical development programme -

Chicago, USA, Ingelheim, Germany – 9 December 2010 – New data to be presented show that afatinib (BIBW 2992) leads to a significant four-fold extension (4.4 months vs. 1 month for placebo) in progression-free survival, - the time before a tumour starts to grow again- , for lung cancer patients most likely to have an epidermal growth factor receptor (EGFR) mutation. In addition, this sub-group of patients showed a trend towards prolonged overall survival. In previously presented results, the lack of overall survival seen in the overall trial population may have been due to confounding effects by the use of extensive subsequent therapies. The new updated post-hoc analysis for Boehringer Ingelheim’s investigational cancer compound afatinib comes from the phase IIb/III LUX-Lung 1 clinical trial, and is to be presented at the Chicago Multidisciplinary Symposium in Thoracic Oncology, USA¹.

References:

1. Miller et al. Phase IIb/III double-blind randomized trial of BIBW 2992, an irreversible inhibitor of EGFR/HER1 and HER2 + best supportive care (BSC) versus placebo + BSC in patients with NSCLC failing 1–2 lines of chemotherapy and erlotinib or gefitinib (LUX-Lung 1). Oral presentation at The European Society of Medical Oncology (ESMO) annual meeting, Milan, October 2010. Abstract ID: LBA1