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.
For more information about this presentation, please contact AUA Communications Manager Wendy Waldsachs Isett at 410-977-4770. Dial-in information for the April 28 press conference is available for those reporters unable to attend the session in person.
About the American Urological Association: Founded in 1902 and headquartered near Baltimore, Maryland, the American Urological Association is the pre-eminent professional organization for urologists, with more than 16,000 members throughout the world. An educational nonprofit organization, the AUA pursues its mission of fostering the highest standards of urologic care by carrying out a wide variety of programs for members and their patients.
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