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Results From an Expanded Cohort Phase 1 Study Published in the New England Journal of Medicine Demonstrate a Majority of Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer Responded to Crizotinib (PF-02341066)
Date:10/27/2010

NEW YORK, Oct. 27 /PRNewswire-FirstCall/ -- Pfizer Inc. (NYSE: PFE) announced today the publication of data showing that 57 percent of ALK-positive advanced non-small cell lung cancer (NSCLC) patients treated with crizotinib (PF-02341066), an investigational oral anaplastic lymphoma kinase (ALK) inhibitor, had either a complete (one patient) or partial (46 patients) response to treatment.  Data from 82 patients in this Part 2 expansion cohort of the Phase 1 study were published in the October 28 issue of the New England Journal of Medicine.(1)

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"It is gratifying to learn of responses like those seen in our study of crizotinib (PF-02341066), especially when you consider that most patients had already received two or more therapies by the time they entered the trial," said Dr. Eunice Kwak, MD, Ph.D., department of medicine, Harvard Medical School, assistant in medicine, hematology/oncology, Massachusetts General Hospital and lead author of the study.  "As we're discovering more about lung cancer, we have confirmed the fundamental need to test tumors for molecular changes, like the ALK fusion gene, so we can better identify the patients who may benefit from certain treatments."

Updated results from this study were also recently presented at the 35th Congress of the European Society for Medical Oncology (ESMO) in Milan, Italy, reporting on 113 patients and preliminary median progression-free survival (PFS) data of 9.2 months.(2)

Study A8081001 is a 2-part Phase 1 open-label, multi-center study evaluating crizotinib (PF-02341066), in patients with solid tumors.(3)  The Part 2 expansion cohort from study A8081001 is evaluating the safety and response of crizotinib (PF-02341066) in patients with ALK'/>"/>

SOURCE Pfizer Inc.
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