Boehringer Ingelheim Pharmaceuticals, Inc. announced results from two clinical trials for its investigational cancer compound afatinib (BIBW 2992) presented at the 35th European Society for Medical Oncology (ESMO) Congress in Milan, Italy. In the phase IIb/III LUX-Lung 1 study, afatinib tripled the secondary endpoint of progression free survival (PFS) but did not extend the primary endpoint of overall survival (OS) in late-stage patients with non-small cell lung cancer (NSCLC).(1)

Afatinib is an investigational orally administered irreversible inhibitor of both the epidermal growth factor receptor (EGFR) and human epidermal receptor 2 (HER2) tyrosine kinases. Afatinib is under development in several solid tumors including NSCLC, breast and head and neck cancer.

The LUX-Lung 1 trial compared afatinib to placebo in over 580 patients with advanced NSCLC who had received chemotherapy and a prior EGFR tyrosine kinase inhibitor (EGFR TKI; gefitinib or erlotinib);(1) results show:

-- Afatinib did not improve OS compared to placebo 10.78 months vs. 11.96 months, respectively (HR = 1.08, 95% CI 0.86 to 1.35)(1)

-- As a secondary endpoint, afatinib extended PFS three-fold compared to placebo (3.3 months vs. 1.1 months) (HR = 0.38, 95% CI 0.31 to 0.48, p