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Boehringer Ingelheim to present pivotal Phase III results for afatinib in first-line treatment of EGFR mutation-positive NSCLC at ASCO 2012
Date:5/16/2012

ational compound.  Afatinib is not approved by the FDA; its safety and efficacy have not been established. 

Afatinib is an investigational oral, once-daily irreversible ErbB Family Blocker that specifically inhibits epidermal growth factor receptor (EGFR or ErbB1), human epidermal receptor 2 (HER2 or ErbB2), ErbB3 and ErbB4.  It is currently in phase III clinical development in NSCLC, head and neck and breast cancer. 

About the Afatinib Clinical Trial Program in Advanced NSCLCThe LUX-Lung studies evaluate the use of afatinib in various settings of advanced NSCLC, including in patients harboring EGFR mutations and those with recurrent disease.  These trials include:

  • LUX-Lung 1, a Phase IIb/III trial investigating afatinib plus best supportive care (BSC) versus placebo plus BSC in NSCLC patients who were previously treated with first-line chemotherapy and the reversible EGFR TKIs erlotinib or gefitinib.
  • LUX-Lung 2, a Phase II trial evaluating afatinib in NSCLC patients with EGFR mutations (EGFR M+), either treatment-naive or after one line of treatment with chemotherapy.
  • LUX-Lung 3, a Phase III trial investigating afatinib as a first-line treatment in patients with advanced NSCLC with EGFR mutations. 
  • LUX-Lung 4, a Phase I/II trial of afatinib in NSCLC patients who have progressed after conventional EGFR-TKI treatment. 
  • LUX-Lung 5, a global Phase III trial in patients previously treated with erlotinib or gefitinib. This is the first randomized Phase III trial investigating whether patients who initially benefit from treatment with afatinib alone may further benefit from afatinib beyond progression when given in combination with chemotherapy.
  • LUX-Lung 6, a Phase III trial investigating the efficacy and safety of afatinib compared to standard chemotherapy for first-line treatment of NSCLC patients with EGFR mutations.
  • LUX-Lung 7, a Phase IIb trial e
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  • SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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