Pfizer announces publication of crizotinib data for NSCLC patients in New England Journal of Medicine

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.

"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.

Study A8081001 is a 2-part Phase 1 open-label, multi-center study evaluating crizotinib (PF-02341066), in patients with solid tumors.  The Part 2 expansion cohort from study A8081001 is evaluating the safety and response of crizotinib (PF-02341066) in patients with ALK-positive advanced NSCLC treated with a dose of 250 mg twice daily.

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

"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, 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. 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.

For more information on these clinical trials, please contact the Pfizer Oncology Clinical Trial Information Service at 1-877-369-9753 (US/Canada) or 1-646-277-4066 (international), via email at [email protected] or visit www.pfizercancertrials.com.

Study Results Published in the New England Journal of Medicine

In the Part 2 expansion cohort study which included 82 patients with ALK-positive advanced NSCLC, 57 percent>

At the time of the analysis, 77 percent of patients>

The most commonly reported all-grade adverse events associated with crizotinib included nausea> Tumors in the analysis were primarily of adenocarcinoma histology, and patients tended to be young, and were never or former light smokers.  Ninety-three percent of patients> ALK-positive advanced NSCLC, independent of the number of previous chemotherapies, followed the completion of the dose-escalation study which enrolled 37 advanced cancer patients with various tumors, including NSCLC, colorectal, pancreatic and inflammatory myofibroblastic tumor (IMT) tumors.

These data were previously presented at the 2010 American Society of Clinical Oncology Annual Meeting.