Biotech Values

[DewDiligence]

PFE’s Dacomitinib* fails two phase-3 studies in NSCLC; one trial ongoing:

http://finance.yahoo.com/news/pfizer-announces-top-line-results-120000873.html

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 3 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-naïve (without prior treatment) patients with EGFR-mutant advanced NSCLC. The results are expected in 2015.

… Dacomitinib is an oral, once-daily, irreversible pan-HER (pan-human epidermal growth factor receptor) kinase inhibitor. Dacomitinib irreversibly inhibits the kinase activity of HER1/EGFR, HER2, and HER4 by binding covalently to the receptor tyrosine kinase domains and preventing autophosphorylation, thereby inhibiting downstream signaling and leading to tumor-growth inhibition and apoptosis.

*f/k/a PF-00299804.