Published on April 29, 2009 at 11:51 PM
Sipuleucel-T (Provenge), an experimental immunotherapy improved survival in men with metastatic disease, according to new results to be presented April 28 at the American Urological Association (AUA) Annual Scientific Meeting in Chicago.
These data from the Phase 3 Immunotherapy for Prostate AdenoCarcinoma Treatment (IMPACT) study were presented during the meeting's Late Breaking Science Forum.
Compared to placebo, sipuleucel-T extended median survival by 4.1 months and improved three-year survival by 38 percent. Sipuleucel-T successfully exceeded the pre-specified level of statistical significance defined by the study's design and reduced the overall risk of death by 22.5 percent compared to placebo (p-value=0.032). More than 500 patients were enrolled in the IMPACT trial, a multi-center, randomized, double-blind, placebo-controlled study evaluating men with asymptomatic or minimally symptomatic, metastatic, androgen-independent prostate cancer. The primary endpoint was overall survival.
Researchers are encouraged by the findings, citing an impressive effect on long-term survival for patients, compared to placebo.
"The ability to boost survival for patients is the gold standard endpoint in prostate cancer clinical trials," said AUA spokesperson Ira D. Sharlip, MD. "The ability to give these patients both increased survival and possibly, improved quality of life, is very important."
Sipuleucel-T is an investigational therapy for men with androgen-independent prostate cancer. It is an active cellular immunotherapy designed to use live human cells to boost a patient's immune system to elicit a long-lasting response against cancer.
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