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Boehringer Ingelheim to Commence Phase III Study Investigating the Role of BIBW 2992 as First-Line Treatment for Non-Small Cell Lung Cancer (NSCLC) Patients with EGFR Mutations
Date:8/3/2009

RIDGEFIELD, Conn., Aug. 3 /PRNewswire/ -- Boehringer Ingelheim announced today at the International Association for the Study of Lung Cancer's 13th World Conference on Lung Cancer (WCLC), San Francisco, CA, the initiation of a Phase III clinical study of BIBW 2992 as first-line treatment in non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutations. BIBW 2992 is the first orally-administered irreversible dual inhibitor of EGFR and HER2,(1) to reach Phase III development in NSCLC.(2)

The LUX-Lung 3 trial will compare the efficacy and safety of the single-agent BIBW 2992 to that of standard chemotherapy (cisplatin/pemetrexed) as a potential first-line treatment for NSCLC patients with EGFR mutations.(3) Boehringer Ingelheim's LUX-Lung trial program currently includes two Phase III trials assessing the efficacy and safety of BIBW 2992 in various NSCLC patient populations across the globe.

"The Boehringer Ingelheim LUX-Lung 3 trial studying BIBW 2992 in patients with EGFR mutations will be important as we continue to work towards providing personalized medicine for patients with lung cancer," said James Yang, MD, PhD, professor at the Graduate Institute of Clinical Medicine and the Graduate Institute of Clinical Pharmacy at the College of Medicine at the National Taiwan University (NTU). "BIBW 2992 is an irreversible tyrosine kinase inhibitor(1) whose clinical benefit we are hoping to confirm in the first-line setting for patients with EGFR mutations."

This milestone coincides with the oral presentations of new data at WCLC suggesting the compound's potential:

  • Preliminary data from the Phase II LUX-Lung 2 trial of NSCLC patients with an EGFR mutation show a response rate of nearly two-thirds (63%) and a disease control rate of 97% in 38 evaluable first-line patients.(4) The most commonly (greater than 5%) observe
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