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Topline Results From Phase 3 Trial of Sunitinib With Erlotinib in Advanced Non-Small Cell Lung Cancer (NSCLC)
Date:8/23/2010

NEW YORK, Aug. 23 /PRNewswire-FirstCall/ -- Pfizer Inc. (NYSE :PFE) announced today that the SUN 1087 trial of sunitinib in combination with erlotinib versus erlotinib demonstrated a statistically significant improvement in Progression-Free but not in Overall Survival in patients with previously treated advanced non-small cell lung cancer (NSCLC).  Overall survival was the primary endpoint of the study and Progression-Free Survival was a secondary endpoint of the study.  No new or unexpected types of adverse events were observed in the study.  Pfizer is continuing to analyze study data, and the results have been submitted to the European Society for Medical Oncology (ESMO) Congress, October 8-12, 2010 in Milan, Italy.

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"While this trial did not demonstrate a statistically significant improvement in overall survival for patients treated with sunitinib plus erlotinib, we believe that the statistically significant improvement in progression free survival is an important finding.  Over the next few months, we will conduct an in-depth analysis to gain further insight into these results and determine whether we can identify one or more subgroups of non-small cell lung cancer patients for a future trial in either previously untreated or recurrent disease," said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs for Pfizer's Oncology Business Unit.  "Pfizer is committed to improving outcomes for patients with lung cancer."  

Sutent is currently approved for both gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate, and advanced/metastatic renal cell carcinoma (RCC) based on efficacy and safety data from large, randomized Phase 3 clinical trials.  Sutent has played a significant role in advancing the treatment landscape and remains standard of care in its approved indications.  To date, more than 91,000 patients globally have been treated with sunitinib in the clinical setting and in trials.

Pfizer Oncology is committed to further developing Sutent in other tumor types where there is promise and a need for additional treatment options and continues to evaluate the potential role of Sutent as a treatment for advanced castration-resistant prostate cancer and as adjuvant therapy for renal cell carcinoma in Phase 3 trials.

Pfizer Oncology is dedicated to improving outcomes for patients with lung cancer and has multiple compounds in development to treat the various forms of the disease, including Phase 3 trials for crizotinib (PF-02341066), a first-in-class oral ALK (anaplastic lymphoma kinase) inhibitor, and PF-00299804, an irreversible, oral, selective pan-HER (human epidermal growth factor receptor) inhibitor.

About Non-Small Cell Lung Cancer

Lung cancer is the most common cancer worldwide.  NSCLC accounts for about 85 percent of lung cancer cases and remains difficult to treat, particularly in the metastatic setting.  Approximately 75 percent of NSCLC patients are diagnosed late with metastatic, or advanced, disease.  For Stage III/IV NSCLC, the five-year survival rate is only 6 percent.

About Sutent® (sunitinib malate)

Sutent is an oral multi-kinase inhibitor approved for the treatment of GIST after disease progression on or intolerance to imatinib mesylate and advanced/metastatic RCC.

Sutent works by blocking multiple molecular targets implicated in the growth, proliferation and spread of cancer.  Two important Sutent targets, vascular endothelial growth factor receptor (VEGFR) and platelet-derived growth factor receptor (PDGFR), are expressed by many types of solid tumors and are thought to play a crucial role in angiogenesis, the process by which tumors acquire blood vessels, oxygen and nutrients needed for growth.  Sutent also inhibits other targets important to tumor growth, including KIT, FLT3 and RET.

Important Sutent® (sunitinib malate) Safety Information

Hepatotoxicity has been observed in clinical trials and post-marketing experience.  This hepatotoxicity may be severe, and deaths have been reported.  It is recommended to monitor liver function tests before initiation of treatment, during each cycle of treatment, and as clinically indicated.  Sutent should be interrupted for Grade 3 or 4 drug-related hepatic adverse events and discontinued if there is no resolution.  Sutent should not be restarted if patients subsequently experience severe changes in liver function tests or have other signs and symptoms of liver failure.  

Women of childbearing age who are (or become) pregnant during therapy should be informed of the potential for fetal harm while on Sutent.

Decreases in left ventricular ejection fraction (LVEF) to below the lower limit of normal (LLN) have been observed.  Patients with concomitant cardiac conditions should be carefully monitored for clinical signs and symptoms of congestive heart failure. Patients should be monitored for hypertension and treated as needed with standard antihypertensive therapy.  Complete blood counts (CBCs) with platelet count and serum chemistries should be performed at the beginning of each treatment cycle for patients receiving treatment with Sutent.

The most common adverse reactions in GIST and RCC clinical trials were diarrhea, fatigue, asthenia, nausea, mucositis/stomatitis, anorexia, vomiting, hypertension, dyspepsia, abdominal pain, constipation, rash, hand-foot syndrome, skin discoloration, altered taste and bleeding.  For more information on Sutent and Pfizer Oncology, including full prescribing information for Sutent (sunitinib malate), please visit www.pfizer.com.

About Pfizer Oncology

Pfizer Oncology is committed to the discovery, investigation and development of innovative treatment options to improve the outlook for cancer patients worldwide.  Our strong pipeline, one of the most robust in the industry, is studied with precise focus on identifying and translating the best scientific breakthroughs into clinical application for patients across a wide range of cancers, including breast, lung, prostate, sarcoma, melanoma, and various hematologic cancers.  Pfizer Oncology has biologics and small molecules in clinical development and more than 200 clinical trials underway.

By working collaboratively with academic institutions, individual researchers, cooperative research groups, governments, and licensing partners, Pfizer Oncology strives to cure or control cancer with breakthrough medicines, to deliver the right drug for each patient at the right time.  For more information please visit www.Pfizer.com.

DISCLOSURE NOTICE: The information contained in this release is as of August 23, 2010. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or development.

This release contains forward-looking information that involves substantial risks and uncertainties about (i) certain potential additional indications for Sutent, including their potential benefits; (ii) the potential of identifying one or more subgroups of non-small cell lung cancer patients for whom it would  be appropriate to conduct a future Sutent trial; and (iii) two product candidates, crizotinib and PF-00299804, including their potential benefits.. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; decisions by regulatory authorities regarding whether and when to approve any supplemental drug applications that may be filed for additional indications for Sutent and any drug applications that may be filed for crizotinib and PF-00299804 as well as the decisions of regulatory authorities regarding labeling and other matters that could affect their availability or commercial potential; and competitive developments.

A further list and description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2009 and in its reports on Form 10-Q and Form 8-K.


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