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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

RIDGEFIELD, Conn., Dec. 9, 2010 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. announced that new data from a subgroup analysis of the phase IIb/III LUX-Lung 1 trial show that afatinib (BIBW 2992) reached a four-fold extension (4.4 months vs. 1.0 month for placebo) in progression-free survival (PFS) in advanced non-small cell lung cancer (NSCLC) patients most likely to have an epidermal growth factor receptor (EGFR) mutation.(1)  The updated LUX-Lung 1 data will be presented at the Chicago Multidisciplinary Symposium in Thoracic Oncology.

The LUX-Lung 1 trial compared afatinib to placebo in 585 patients with advanced NSCLC whose disease progressed after receiving chemotherapy and a first-generation EGFR tyrosine kinase-inhibitor (TKI), gefitinib or erlotinib. In the study, afatinib did not extend the primary endpoint of overall survival in these advanced NSCLC patients.(2)  In addition, patients in the subgroup receiving afatinib did not have a statistically significant increase in overall survival compared to placebo. The authors concluded that the overall survival endpoint may have been confounded by the use of extensive subsequent systematic therapies.(2)  The subgroup included in the new analysis comprised two-thirds of all patients from the study (385/585) who were most likely to have EGFR mutations, as determined by clinical criteria based on their response to and duration of prior treatment with EGFR-TKIs.(1) These findings build upon the initial results from the LUX-Lung 1 clinical trial presented at the recent European Society for Medical Oncology (ESMO) meeting in Milan.(2)

The two most common side effects associated with treatment with afatinib in the LUX-Lung 1 trial were diarrhea (87% all grades, with 17% Grade 3) and rash/acne (79% all grades, with 14% Grade 3).  These side effects were usually well-managed by supportive care and dose reduction.(2)

"We continue to be encouraged by the findings o
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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