Results For Pfizer Trials Of Dacomitinib For Lung Cancer
By Cyndi Root
Pfizer Inc. announced in a press release that it has produced results in two studies of dacomitinib. The drug treats people with advanced non-small cell lung cancer (NSCLC). The two randomized Phase 3 studies evaluated patients with advanced NSCLC who had previously been seen for treatment. Non-Small Cell Lung Cancer accounts for the majority of lung cancer cases and is the leading cause of cancer deaths. Metastatic lung cancer is especially difficult to treat and only about five percent of patients survive to the five-year mark.
Dacomitinib
Dacomitinib is not approved for market in any country and is considered an investigational compound. It is administered orally, once daily. The drug is in a class of drugs called kinase inhibitors. The drug inhibits HER1/EGFR, HER2, and HER4 kinase activity. Dacomitinib binds to the tyrosine kinase receptor and prevents autophosphorylation. This action mechanism inhibits signaling downstream and slows tumor growth.
ARCHER 1009 Trial
The ARCHER 1009 trial did not prove successful. It did not meet the primary objective of statistical improvement in progression-free survival (PFS). Compared to erlotinib, an EGFR inhibitor, dacomitinib was not superior. The study included two populations of people with NSCLC who had previously received chemotherapy treatment.
NCIC CTG BR.26 Trial
In a separate trial, the NCIC CTG BR.26 trial, investigators found that dacomitinib failed to meet the objective of prolonging overall survival (OS). Patients included those with advanced NSCLC that had received treatment with an EGFR tyrosine kinase inhibitor and chemotherapy. The study was double-blind, randomized, and included a placebo.
Dr. Mace Rothenberg, Senior Vice President of Clinical Development and Medical Affairs and Chief Medical Officer for Pfizer Oncology said, “While we are disappointed in the results, lung cancer is a complex disease, and the use of targeted agents to treat specific patient populations continues to evolve.” He added that the company is analyzing the results from both trials to better understand patient subgroups, EGFR mutations, and molecular actions of dacomitinib.
The company plans to present the findings of both studies at upcoming medical meetings. Pfizer plans further evaluation of dacomitinib in the ARCHER 1050 trial. Along with the SFJ Pharmaceuticals Group, ARCHER 1050 studies are planned in sites in Asia and Europe.
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