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New Subgroup Analysis of LUX-Lung 1 Trial Suggests Afatinib Increases Progression-Free Survival in Advanced Lung Cancer Patients More Likely to Have EGFR Mutations
Date:12/9/2010

f this study as we move toward personalized treatments," said principal investigator Vincent A. Miller, M.D., associate attending physician at Memorial Sloan Kettering Cancer Center, New York. "These data suggest that a certain subgroup of patients – those most likely to have EGFR mutations – may respond more positively with afatinib, and warrant further investigation."

As part of Boehringer Ingelheim's comprehensive and robust LUX clinical trial program, the phase III LUX-Lung 3 trial recently began to specifically investigate afatinib as a first-line treatment in patients with advanced NSCLC who have EGFR mutations.

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

About Afatinib's Clinical Trial Program: LUX Trial Program

The LUX trial program is a comprehensive program that comprises more than 10 trials conducted across the globe, investigating afatinib in a variety of different solid tumor types, including NSCLC, breast and head and neck cancer.

LUX-Lung 1 was a phase IIb/III trial that investigated afatinib plus best supportive care (BSC) versus placebo plus BSC in NSCLC patients who were previously treated with first-line chemotherapy and first-generation EGFR-TKIs, erlotinib or gefitinib.

LUX-Lung 2 is a phase II trial evaluating afatinib in NSCLC patients with EGFR mutations, either treatment naïve or after one line of chemotherapy.

In two ongoing global phase III trials, LUX-Lung 3 and LUX-Lung 6, the efficacy and safety of afatinib is compared to standard chemotherapy for first-line treatment of NSCLC patients with EGFR mutations in different geographic
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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