Dacomitinib fails two Phase III trials for NSCLC- Pfizer

Pfizer Inc. announced top-line results from two randomized Phase III studies of the irreversible pan-HER kinase inhibitor dacomitinib in patients with advanced Non-Small Cell Lung Cancer (NSCLC). Both trials evaluated dacomitinib in populations of previously treated patients with advanced NSCLC.

The ARCHER 1009 trial, which included patients previously treated with chemotherapy (second/third line), did not meet its objective of demonstrating statistically significant improvement in progression-free survival (PFS) when compared with the EGFR inhibitor erlotinib. Separately, the NCIC CTG BR.26 trial, which included patients with advanced NSCLC after standard therapy with both chemotherapy and an EGFR tyrosine kinase inhibitor had failed, did not meet its objective of prolonging overall survival (OS) versus placebo. An ongoing, third Phase III trial, ARCHER 1050, is evaluating PFS of dacomitinib in a different patient population than was studied in ARCHER 1009 and BR26. ARCHER 1050 compares dacomitinib versus gefitinib in treatment-na�ve (without prior treatment) patients with EGFR-mutant advanced NSCLC. The results are expected in 2015.