Provenge Significantly Improves Survival Advanced Prostate Cancer
ORLANDO, Fla., Feb. 17 Dendreon Corporation announced today that Provenge, the Company's investigational immunotherapy for the treatment of prostate cancer, significantly improved survival in men with asymptomatic, metastatic androgen-independent (hormone-refractory) prostate cancer when compared to patients who were receiving placebo. Eric J. Small, M.D., professor of medicine and urology at the University of California, San Francisco, will present the final data from the D9901 study on Saturday, February 19 at the 2005 Multidisciplinary Prostate Cancer Symposium.
This is a three-year intent-to-treat analysis of the Company's first randomized Phase 3 clinical study, in which patients receiving Provenge had a 4.5 month improvement in their median survival and a greater than 3-fold increase in survival at 36 months when compared to patients receiving placebo.
The survival benefit seen with Provenge is the largest ever reported in this patient population with any therapy as per Dr. Small. He stated that the survival benefit, combined with a favorable safety profile, has the potential to provide an important new treatment option for prostate cancer patients.
Patients receiving Provenge had a median survival of 25.9 months compared to 21.4 months for patients in the placebo arm, a 4.5 month improvement in survival (p-value = 0.01, hazard ratio = 1.7). Hazard ratio implies that patients receiving placebo have a relative risk of dying that is 70 percent higher than those patients receiving Provenge. In addition, 34 percent of patients receiving Provenge were alive at 36 months compared to 11 percent of patients receiving placebo (p-value = 0.0046). The survival benefit seen with Provenge was independent of a patient's Gleason Score, a common measure of disease aggressiveness. Provenge was well tolerated with the most common adverse events reported being fever and chills lasting for one to two days.
Details of the study
The D9901 study was a double-blind, placebo-controlled Phase 3 trial aimed at evaluating Provenge in men with asymptomatic, metastatic androgen independent prostate cancer. The goal of the study was The study was to measure time to disease progression and time to development of disease-related pain in men with androgen independent prostate cancer. A 36 month final survival analysis was required per the study design. The study randomized 127 men to receive three infusions of Provenge or placebo over a four-week period.
Details on Provenge
Provenge is designed to stimulate a patient's immune system against prostate cancer cells. It is developed through Dendreon's proprietary Antigen Delivery Cassette technology, which utilizes a recombinant form of an antigen found in 95 percent of prostate cancers, prostatic acid phosphatase (PAP). Provenge is being further evaluated in an ongoing, another pivotal Phase 3 trial (D9902B) under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration. Provenge also has Fast Track designation. This double-blind, placebo-controlled trial is still enrolling patients at leading cancer centers around the country. To learn more about the trial, go to www.dendreon.com.