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Boehringer Ingelheim to present new data at ASCO annual meeting regarding its investigational compound afatinib in EGFR-mutation positive patients with advanced NSCLC
Date:5/25/2011

body of research, ASCO issued a provisional clinical opinion in April 2011 stating that patients with NSCLC who are being considered for first-line therapy with an EGFR TKI should have their tumor tested for EGFR mutations to determine whether an EGFR TKI or chemotherapy is the appropriate first-line therapy.(3) Earlier this year, NCCN updated its clinical practice guidelines to include a category 1 recommendation for EGFR testing after a histologic diagnosis of adenocarcinoma, large cell carcinoma or undifferentiated carcinoma.(4)

It is believed that approximately 5-20 percent of NSCLC patients have mutations of the EGFR tyrosine kinase, with an increased frequency in patients with adenocarcinoma, Asian ethnicity and former/nonsmoking status.(5,6)

About Afatinib

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

Afatinib is an orally-administered irreversible inhibitor of the erbB family of receptor tyrosine kinases, specifically EGFR and HER2.  It is in late-stage development in several solid tumors including advanced NSCLC and breast cancer.  

About the Afatinib Clinical Program

Boehringer Ingelheim is actively developing targeted therapies – biologicals and small molecules – in areas of unmet medical need. This includes both solid and hematological cancers.  The company's comprehensive LUX clinical trial program includes, among other trials, more than 10 registration trials investigating afatinib for potential approval for a variety of solid tumor types, including NSCLC, breast and head and neck cancer.  

LUX-Lung 1 was 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 is a phase II
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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