SEATTLE, May 5 (UPI) -- U.S. scientists have determined sipuleucel-T, a prostate cancer immunotherapy drug, significantly prolongs survival in men with advanced prostate cancer.
A Phase 3 trial showed sipuleucel-T (Provenge) improved survival in men with metastatic disease. The Seattle-based Dendreon Corp., manufacturer of the drug, said compared with placebo, sipuleucel-T extended median survival by 4.1 months and improved three-year survival by 38 percent.
The researchers said 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, as compared with placebo. More than 500 patients took part in the multi-center, randomized, double-blind, placebo-controlled study.
"The ability to boost survival for patients is the gold standard endpoint in prostate cancer clinical trials," said AUA spokesman Dr. Ira 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.
The trial's results were presented last week in Chicago during the American Urological Association's annual scientific meeting.
