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, Thursday, December 9th 2010 [ME NewsWire]:

(BUSINESS WIRE)-- 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.


The LUX-Lung 1 trial compared afatinib to placebo in patients with advanced non-small cell lung cancer (NSCLC) whose disease progressed after receiving chemotherapy and a first-generation EGFR tyrosine kinase-inhibitor (TKI), gefitinib or erlotinib. The sub-group included in the analysis to be presented comprises two-thirds of all patients from the study (391/585) who were most likely to have EGFR mutations as determined by clinical criteria based on their response to and duration of prior treatment with EGFR-TKIs.


The results presented are an update of the initial results from the LUX-Lung 1 clinical trial, which were presented at the recent European Society for Medical Oncology (ESMO) meeting in Milan2.


"We continue to be encouraged by the findings of this study as we move towards personalised treatments" said Vincent A. Miller, M.D. Principal Investigator, Medical Oncologist, Memorial Sloan-Kettering Cancer Center, USA. "These data not only demonstrate the activity of afatinib, but they suggest that a certain sub-group of patients - those most likely to have EGFR mutations - may respond more positively with afatinib."


Afatinib is an investigational orally-administered irreversible inhibitor of both the EGFR and human epidermal receptor 2 (HER2) tyrosine kinases that is under development in several solid tumors including NSCLC, breast and head and neck cancer.


As part of Boehringer Ingelheim’s comprehensive LUX clinical trial programme, a phase III trial called LUX-Lung 3 has been started which will specifically investigate afatinib as a first-line treatment in patients with advanced NSCLC who harbour EGFR mutations.


Notes to Editors: http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2010/09_december_2010_oncology.html


For more information please visit www.boehringer-ingelheim.com or www.TheWhiteRoom.info


*Afatinib (BIBW 2992) is an investigational compound – its safety and efficacy have not been fully established.


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

2. Miller et al. Subgroup analysis of LUX-Lung 1: A randomized Phase III Trial of Afatinib (BIBW 2992) + Best Supportive Care (BSC) versus Placebo + BSC in Patients with NSCLC Failing 1-2 Lines of Chemotherapy and Erlotinib or Gefitinib. Oral presentation at Chicago Multidisciplinary Symposium in Thoracic Oncology, Chicago, USA, 10 December, 2010


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