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Lung Cancer Drug Dacomitinib Fails Two Phase III Trials

Treatment provides no survival benefit compared with erlotinib or placebo in NSCLC patients (January 27)

Disappointing results have been reported from two randomized phase III studies of an irreversible pan-human epidermal growth factor receptor (pan-HER) kinase inhibitor, dacomitinib (Pfizer), in patients with advanced non–small-cell lung cancer (NSCLC).

Both trials evaluated dacomitinib in previously treated patients with advanced NSCLC. The ARCHER 1009 trial, which included patients previously treated with second- or third-line chemotherapy, did not meet its objective of demonstrating a statistically significant improvement in progression-free survival (PFS) compared with the epidermal growth factor receptor (EGFR) inhibitor erlotinib.

Separately, the NCIC CTG BR.26 trial, which included patients with advanced NSCLC after standard treatment with both chemotherapy and an EGFR tyrosine kinase inhibitor had failed, did not meet its objective of prolonging overall survival versus placebo.

An ongoing, third phase III study, ARCHER 1050, is evaluating PFS with dacomitinib in a different patient population than the one studied in ARCHER 1009 and BR26. ARCHER 1050 is comparing dacomitinib and gefitinib in treatment-naïve patients with EGFR-mutant advanced NSCLC. The results are expected in 2015.

Dacomitinib irreversibly inhibits the kinase activity of HER1/EGFR, HER2, and HER4 by binding covalently to the receptor tyrosine kinase domains and by preventing autophosphorylation, thereby inhibiting downstream signaling and leading to tumor-growth inhibition and apoptosis.

Source: Pfizer; January 27, 2014.

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