FeedDendreon Announces Presentation of Data at American Urological Association Annual Meeting
Data May Support Use of PROVENGE® as Front-line Treatment in Advanced Prostate Cancer
SEATTLE and ANAHEIM, Calif., May 20 -- Dendreon Corporation (Nasdaq: DNDN - News) 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 Surviva"" (#605), written 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).Daniel P. Petrylak, MD, has received grant/research support from, has been a consultant for, and has served on the speakers' bureau of Sanofi Aventis, the company that makes Taxotere; and has served on the advisory board of Aventis Pharmaceuticals.
Related:
Dendreon Announces New Data Analysis Presented at Chemotherapy Foundation Symposium November 10, 2006
Dendreon Announces Preliminary Results From PROTECT (P-11) Study PROVENGE Prolongs PSA Doubling Time in Patients with Early Stage Prostate Cancer November 8, 2006
Provenge prostate cancer vaccine linked to longer survival for asymptomatic hormone refractory stage. June 28, 2006
Dendreon Announces FDA Grants Fast Track Status for Provenge Nov 7, 2005
Dendreon Reports Preliminary D9902A Trial Data For Provenge in Patients With Advanced Prostate Cancer Jan. 11, 2005
Dendreon's Phase 3 Trial Shows Provenge Vaccine Extends Survival in Patients with Advanced Prostate Cancer Oct 28, 2004
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