NEW YORK, Sept. 27 /PRNewswire-FirstCall/ -- Pfizer Inc. announced today the discontinuation of the SUN 1120 Phase 3 trial evaluating SUTENT® (sunitinib malate) in combination with prednisone for men with advanced castration-resistant prostate cancer (CRPC) that had progressed despite treatment with a docetaxel-based chemotherapy regimen. During a scheduled interim analysis, an independent Data Monitoring Committee (DMC) found that the combination of sunitinib with prednisone was unlikely to improve overall survival when compared to prednisone alone. No new or unexpected safety issues were identified. The full data set from this trial is being analyzed and will be presented at an upcoming medical meeting.
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"This planned interim analysis helped us determine that the combination of sunitinib with prednisone would not ultimately improve the overall survival of men with advanced stage, castration-resistant prostate cancer," said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs, Pfizer Oncology Business Unit. "There is a great need for better therapies for prostate cancer and we are committed to working with basic scientists and clinical researchers to identify more effective treatments for this disease."
Sunitinib 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 a standard of care in its approved indications. To date, more than 91,000 patients have been treated with sunitinib worldwide.
Pfizer is evaluating the potential role of sunitinib for the adjuvant treatment of renal cell carcinoma in a Phase 3 trial.
Healthcare professionals who are interested in learning more about Pfizer Oncology clinical trials that are open for enrollment can visit http://www.pfizeroncology.com/clinicaltrials.
About Prostate Cancer
Prostate cancer is one of the most common forms of cancer in men.(i) For patients with castration resistant prostate cancer, who have progressed after treatment with docetaxel, there are limited treatment options available.
About SUTENT(®) (sunitinib malate)
SUTENT is an oral multi-kinase inhibitor approved for the treatment of advanced RCC and for the treatment of GIST after disease progression on or intolerance to imatinib mesylate.
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 child bearing 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 http://www.pfizer.com/.
DISCLOSURE NOTICE: The information contained in this release is as of September 27, 2010. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about a potential additional indication for SUTENT, including its potential benefits, that involves substantial risks and uncertainties. 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 such additional indication for SUTENT as well as their decisions regarding labeling and other matters that could affect its 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.
(i) American Cancer Society. "How Many Men Get Prostate Cancer?" Available at: http://www.cancer.org/docroot/CRI/content/CRI_2_2_1X_How_many_men_get_prostate _cancer_36.asp?sitearea=. Accessed: July 20, 2010.
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