SEATTLE and ANAHEIM, Calif., May 20 /PRNewswire-FirstCall/ -- Dendreon Corporation today announced the presentation of data from an analysis of Phase 3 Studies (D9901 and D9902A) that showed a prolonged survival benefit for patients who were initially treated with PROVENGE (sipuleucel-T) who then went on to receive docetaxel chemotherapy after disease progression. The data were presented today at the American Urological Association (AUA) Annual Meeting in Anaheim, California.
The abstract, titled “Advanced Prostate Cancer Patients who Receive Sipuleucel-T followed by Docetaxel Have Prolonged Survival” (#605), authored by Daniel P. Petrylak, M.D., associate professor of medicine at New York- Presbyterian Hospital at the Columbia University Medical Center, is based on an exploratory analysis conducted to assess the influence of the active cellular immunotherapy PROVENGE on the clinical outcome of patients who subsequently went on to receive docetaxel chemotherapy after primary treatment with PROVENGE. The analysis was conducted by evaluating data from two Phase 3 clinical trials of PROVENGE in patient with asymptomatic, metastatic, androgen-independent prostate cancer (AIPC).
“The results of this analysis suggest that the use of sipuleucel-T as a first-line treatment followed by the chemotherapy docetaxel upon disease progression may provide patients with a substantially prolonged survival benefit,” said Dr. Petrylak. “This analysis provides valuable clinical insight as to how the treatment of men with advanced prostate cancer will likely evolve with the potential introduction of new products like sipuleucel- T that complement the currently available treatment regimens for men with advanced prostate cancer.”
Study Design and Results
This analysis was conducted by evaluating data from two identically designed randomized Phase 3 trials (D9901 and D9902A; n=225) conducted in men with asymptomatic, metastatic, androgen independent prostate cancer. Survival analyses were performed on the subgroup of 82 patients in the trials that were documented to have received docetaxel chemotherapy following initial treatment with either PROVENGE or placebo.
According to the analysis, the patients who received initial treatment with PROVENGE followed by docetaxel had a median survival of 34.5 months compared to 25.4 months for those patients in the placebo arm who received treatment with docetaxel chemotherapy, a 9.1 month difference. In addition, an analysis of overall survival demonstrated that patients in the PROVENGE arm who received subsequent therapy with docetaxel had a 47 percent reduction in their risk of death compared to those in the placebo arm who received subsequent therapy with docetaxel (HR = 1.90, p-value = 0.023).
About Prostate Cancer
Prostate cancer is the most common non-skin cancer in the United States and the third most common cancer worldwide. More than one million men in the United States have prostate cancer, with an estimated 218,890 new cases expected to be diagnosed in 2007, and more than 27,000 men expected to die this year from the disease.
About PROVENGE
PROVENGE (sipuleucel-T) is an investigational product that may represent the first in a new class of active cellular immunotherapies (ACIs) that are uniquely designed to stimulate a patient’s own immune system. PROVENGE is in late-stage clinical development for the treatment of patients with early-stage and advanced prostate cancer. In clinical studies, patients typically received three infusions over a one-month period as a complete course of therapy.
About Dendreon
Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development and commercialization of novel therapeutics that harness the immune system to fight cancer. The Company applies its expertise in antigen identification, engineering and cell processing to produce active cellular immunotherapy product candidates designed to stimulate an immune response. Active cellular immunotherapy holds promise because it may provide patients with a meaningful clinical benefit, such as survival, combined with low toxicity. The Company has headquarters in Seattle and is traded on The Nasdaq Stock Market(R) under the symbol DNDN. For more information about the Company and its programs, visit www.dendreon.com.
Except for historical information, this news release contains forward- looking statements that are subject to risks and uncertainties surrounding the efficacy of PROVENGE to treat men suffering from prostate cancer, risks and uncertainties surrounding the presentation of data to the FDA and approval of product applications by the FDA and risks and uncertainties inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics. Factors that may cause such differences include risks related to our limited operating history, risks associated with completing our clinical trials, the risk that the safety and/or efficacy results of a clinical trial for PROVENGE will not support our biologics license application, the risk that the FDA may interpret data differently than we do or require more data or a more rigorous analysis of data than expected, the risk that the FDA will not approve a biologics license application for a therapeutic, the risk that the results of existing clinical trials data or from additional clinical trials for PROVENGE or other products may not be indicative of results obtained in a later clinical trial, risks that we may lack the financial resources and access to capital to fund required clinical trials or commercialization of PROVENGE, our dependence on the efforts of third parties, and our dependence on intellectual property. Further information on the factors and risks that could affect Dendreon’s business, financial condition and results of operations are contained in Dendreon’s public disclosure filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.
Dendreon Corporation
CONTACT: Monique Greer, Sr. Director, Corporate Communications of DendreonCorporation, +1-206-829-1500
Web site: http://www.dendreon.com//
