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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

>-positive advanced NSCLC treated with a dose of 250 mg twice daily.(1)

Crizotinib (PF-02341066) is a first-in-class compound that inhibits the anaplastic lymphoma kinase, or ALK.(4)  ALK is believed to be a tumor-exclusive target that is a key driver of oncogenesis, or tumor development.(5)  Approximately 3-5 percent of NSCLC tumors are ALK-positive.(4)

"The development of crizotinib is a testament to the benefits of collaboration and partnership, between industry and academia, with investigators from all over the world, including the United States, Japan, Korea and Australia, working together with the goal of discovering a more effective treatment for advanced NSCLC patients with few other options," said Dr. Mace Rothenberg, senior vice president of clinical development and medical affairs for Pfizer's Oncology Business Unit.  "While this is a Phase 1 study, the high response rates observed in patients with ALK+ NSCLC who received crizotinib suggest that we may be one step closer to the development of "precision" or "personalized" cancer treatments that target specific genetic factors that drive certain tumors."

Pfizer is continuing to study crizotinib (PF-02341066) in an ongoing clinical development program,(6,7) and plans to submit crizotinib (PF-02341066) data in the first half of next year to the U.S. Food and Drug Administration (FDA) for regulatory review.  

Additional trials of crizotinib (PF-02341066) include a randomized, Phase 3 open-label study, PROFILE 1007 (A8081007), evaluating the safety and anti-tumor activity of crizotinib (PF-02341066) versus standard of care chemotherapy in patients with previously treated ALK-positive advanced NSCLC.(5)  PROFILE 1005 (A8081005) is a Phase 2 open-label, single-arm study of efficacy and safety of crizotinib (PF-02341066) in patients with ALK-positive advanced NSCLC who have received more than one line of prior chemotherapy.(6)

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SOURCE Pfizer Inc.
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