PARIS, Oct. 31 /PRNewswire-FirstCall/ -- Dendreon Corporation today announced that final results of its second Phase 3 study (D9902A) of PROVENGE(R) (sipuleucel-T), the Company’s investigational active cellular immunotherapy for the treatment of prostate cancer, were presented here today during a late-breaking clinical trials session at ECCO 13-the European Cancer Conference. Researchers concluded that these results are consistent with the results from the Company’s first Phase 3 study (D9901). The Company recently announced plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) to market PROVENGE based on discussions of these data with the FDA.
“The combined data from the trials of PROVENGE versus placebo demonstrate that active immunotherapy favorably impacts survival in men with asymptomatic, metastatic, androgen-independent prostate cancer,” reported Celestia S. Higano, M.D., director and associate professor of the Genitourinary Oncology Clinical Research Group at the University of Washington, Seattle, who presented the data. “Given the favorable side effect profile, PROVENGE may provide a useful alternative for men prior to initiating chemotherapy.”
Summary of PROVENGE Studies Study 1 Study 2 Studies 1 and 2 (D9901) (D9902A) Integrated N = 127 N = 98 N = 225 Median Survival in months: PROVENGE 25.9 19.0 23.2 Placebo 21.4 15.7 18.9 Median Survival Benefit: % (months) 21% (4.5) 21% (3.3) 23% (4.3) Hazard Ratio 1.7 1.3 1.5 p-value (log rank) p=0.010 p=0.331 p=0.011 Hazard Ratio 2.1 1.9 1.8 p-value (Cox regression, adj.) p=0.002 p=0.023 p=0.0006 36-Month Survival: % (patients) PROVENGE 34% (28) 32% (21) 33% (49) Placebo 11% (5) 21% (7) 15% (12) Study Results
In the D9902A study, the three-year final survival analysis in the intent- to-treat population of the double-blind, placebo-controlled study of PROVENGE in 98 men with asymptomatic, metastatic, androgen-independent (hormone- refractory) prostate cancer showed those patients who received PROVENGE had a 19.0 month median survival time compared with only 15.7 months for the patients who were randomized to receive a placebo. This represents a 3.3 month or 21 percent improvement in median survival for patients who were randomized to receive PROVENGE compared to placebo (p-value = 0.331, log-rank; HR = 1.3). This hazard ratio implies that patients receiving placebo have a relative risk of dying that is 30 percent higher than those patients receiving PROVENGE. A Cox multivariate regression analysis of overall survival, which adjusts for imbalances in prognostic factors known to influence survival, met the criteria for statistical significance (p-value = 0.023; adjusted HR = 1.9). The hazard ratio observed in this analysis was consistent with that seen in the Company’s first Phase 3 study, D9901. In addition, at the three- year final follow up, 32 percent of the men in the PROVENGE group were alive compared to only 21 percent of the men in the placebo group, a 52 percent improvement in the survival rate.
As in previous studies, PROVENGE was well tolerated with the most common adverse events reported being fever and chills lasting for one to two days.
As reported earlier this year, the final three-year follow up of the D9901 study of PROVENGE in 127 men with asymptomatic, metastatic, androgen- independent prostate cancer showed a median survival benefit of 21 percent or 4.5 months and a three-fold improvement in survival at 36 months (p-value = 0.010; HR = 1.7). In addition, a Cox multivariate regression analysis was used to test the validity of the survival benefit seen in this study. The results showed that patients receiving placebo had a relative risk of dying that is more than twice as high as those patients receiving PROVENGE (p-value = 0.002; adjusted HR = 2.1).
Dr. Higano also presented an integrated analysis of the data from studies D9901 and D9902A, which showed a statistically significant survival benefit in the overall intent-to-treat population of 225 patients. In this analysis, patients receiving PROVENGE had a median survival of 23.2 months compared to 18.9 months for patients in the placebo group, a 4.3 month or 23 percent improvement in median survival. This analysis was statistically significant by both log rank (p-value = 0.011; HR = 1.5) and Cox multivariate regression analysis of overall survival (p-value = 0.0006; adjusted HR = 1.8). In addition, at the three-year final follow up, 33 percent of the men who received PROVENGE were alive compared to only 15 percent of the men who received placebo, a greater than 100 percent improvement.
“We were pleased to see a statistically consistent and meaningful survival benefit across the three analyses,” said Robert M. Hershberg, M.D., Ph.D., Dendreon’s chief medical officer. “We will be working closely with the FDA to complete our BLA and to bring PROVENGE to market for men with advanced stage prostate cancer who currently have few appealing treatment options available to them.”
Conference Call Details
LIVE Access on October 31, 2005, 17:30 Paris time; 11:30 a.m. ET; 8:30 a.m. PT:
-- Phone 877-502-9274 (domestic) or +1-913-981-5584 (international) -- Webcast connection through the Dendreon website at www.dendreon.com in the Investors/Webcast section. REPLAY Access: -- Phone replay available at 2:00 p.m. ET for 3 days by calling 888-203-1112 (domestic) or +1-719-457-0820 (international); Passcode: 6720485 -- Webcast replay will be available for 90 days from the Dendreon website at www.dendreon.com in the Investors/Webcast section. About Prostate Cancer
More than one million men in the United States have prostate cancer, with an estimated 220,000 new cases of prostate cancer diagnosed each year. More than 30,000 men die each year from the disease. Prostate cancer is the most commonly diagnosed non-skin cancer in the United States and the third most common cancer worldwide.
About PROVENGE (sipuleucel-T)
The generic name “sipuleucel-T” has been approved by the United States Adopted Names (USAN) Council for Dendreon’s investigational active cellular immunotherapy (ACI) for prostate cancer, previously known as APC8015. If approved, sipuleucel-T will be marketed as 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. ACIs hold promise because they may provide patients with a meaningful survival benefit with low toxicities. PROVENGE targets the prostate cancer antigen, prostatic acid phosphatase (PAP), which is found in approximately 95% of prostate cancers. 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 development of innovative cancer treatments. In addition to its immunotherapies in clinical and preclinical development for a variety of cancers, Dendreon’s product pipeline also includes monoclonal antibody and small molecule product candidates. Dendreon has research and development alliances with Genentech, Inc., Abgenix, Inc. and Dyax Corp. For more information about the company and its programs, visit www.dendreon.com.
Except for historical information contained herein, 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 an application for a biologics license, 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 product for which a biologics license has been applied, the risk that the results of a clinical trial for PROVENGE or other product 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, including collaborators, 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 M. Greer, Sr. Director, Corporate Communications ofDendreon Corporation, 206-829-1500
Web site: http://www.dendreon.com//
