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Dendreon Corporation (NASDAQ:DNDN) has 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 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."

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."

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, visit or call 206/829-1500.
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Publication:Biotech Business
Geographic Code:1USA
Date:Dec 1, 2005

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