Boehringer Ingelheim reports positive results from afatinib phase IIb/III LUX-Lung 1 trial in advanced NSCLC

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.  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.  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.  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. 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.

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.

"We continue to be encouraged by the findings of 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.

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