Pfizer’s Lung Cancer Drug Fails to Meet Goals in Phase 3 Trials

Pfizer

Pfizer Inc. (NYSE:PFE) announced Monday that it’s lung cancer drug, which has been undergoing phase 3 studies, failed to meet its objectives for the studies, according to the Wall Street Journal. The drug, which is called dacomitinib, was developed to treat nonsmall cell lung cancer in patients who have already been treated for the same condition, including patients treated with chemotherapy (second and third line.)

The phase 3 trials of the treatment have involved three different studies. In the first, dacomitinib failed to demonstrate statistically significant improvement toward progression-free survival as compared to an existing cancer drug, erlotinib. In the second, the drug failed to prolong overall survival versus a placebo in patients previously treated with the standard therapy: chemotherapy and a tyrosine kinase inhibitor.

The third trial is underway, and is evaluating the drug’s effectiveness in another, different population of patients who are what’s called treatment-naive, or without prior treatment. This third study will be comparing decomitinib’s effectiveness to that of another drug, gefitinib. The results of that trial will not be available until next year, according to Pfizer.

“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,” said Dr. Mace Armstrong, Pfizer’s senior vice president of Clinical Development and Medical Affairs, according to Pfizer’s press release regarding the dacomitinib studies.

After Pfizer lost exclusivity on its cholesterol-fighting drug Lipitor in 2011, the company has been cutting costs and working to improve its performance by bringing new drugs to market, per the Wall Street Journal.

Dacomitinib is an investigational compound that has not been approved by regulatory bodies in any country. The drug is a type of kinase inhibitor (a pan-human epidermal growth factor receptor kinase inhibitor, specifically) taken orally once daily.

Nonsmall cell lung cancer accounts for approximately 85 percent of lung cancer cases in the U.S., and remains very difficult to treat, with 75 percent of NSCLC patients diagnosed late with metastatic or advanced disease. In such cases, the survival rate is generally about 5 percent. Worldwide, lung cancer is the leading cause of death for both men and women, according a Pfizer press release.

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