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New Afatinib (BIBW 2992) Data in Non-Small Cell Lung Cancer Patients Presented at the 2010 ESMO Congress
Date:10/11/2010

RIDGEFIELD, Conn., Oct. 11 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. announced today results from two clinical trials for its investigational cancer compound afatinib* (BIBW 2992) presented at the 35th European Society for Medical Oncology (ESMO) Congress in Milan, Italy.  In the phase IIb/III LUX-Lung 1 study, afatinib tripled the secondary endpoint of progression free survival (PFS) but did not extend the primary endpoint of overall survival (OS) in late-stage patients with non-small cell lung cancer (NSCLC).(1)      

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

The LUX-Lung 1 trial compared afatinib to placebo in over 580 patients with advanced NSCLC who had received chemotherapy and a prior EGFR tyrosine kinase inhibitor (EGFR TKI; gefitinib or erlotinib);(1) results show:

  • Afatinib did not improve OS compared to placebo – 10.78 months vs. 11.96 months, respectively (HR = 1.08, 95% CI 0.86 to 1.35)(1)
  • As a secondary endpoint, afatinib extended PFS three-fold compared to placebo (3.3 months vs. 1.1 months) (HR = 0.38, 95% CI 0.31 to 0.48, p<0.0001).  The improvement in PFS was apparent across all patient subgroups and has been confirmed by independent review(1)
  • At 8 weeks, there was a significantly higher disease control rate (stable disease and tumor shrinkage) in those patients who took afatinib (58%) vs. those taking placebo (19%), which was also independently verified (p<0.0001)(1)
  • Improvement of the lung cancer-related symptoms of cough, dyspnea and pain was observed in the afatinib arm vs. placebo.  In addition, the time to deterioration of cough, individual dyspnea items an
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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