According to the results of the Phase III IMPACT trial, treatment with Provenge® (sipuleucel-T), an investigational immunotherapy, improved overall survival by 4.1 months among men with metastatic, androgen-independent prostate cancer. These results were presented at the 2009 annual meeting of the American Urological Association.
Other than skin cancer, prostate cancer is the most commonly diagnosed cancer in U.S. men. Each year, there are more than 186,000 new diagnoses of prostate cancer and more than 28,000 deaths from the disease. Metastatic, androgen-independent prostate cancer is a challenging form of the disease to treat because the cancer has spread to distant sites in the body and does not respond to treatment with hormonal therapy.
Provenge is an investigational immunotherapy that is intended to prompt the body’s immune system to respond against the cancer. To evaluate the effect of Provenge among men with metastatic, androgen-independent prostate cancer, researchers conducted a Phase III clinical trial known as IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment). The trial enrolled 512 men. Study participants were treated with either Provenge or a placebo.
- Median overall survival was 25.8 months among men treated with Provenge compared with 21.7 months among men treated with placebo.
- Three-year survival was 31.7% among men treated with Provenge compared with 23.0% among men treated with placebo.
- Provenge did not significantly delay cancer progression.
- Side effects of Provenge included chills, fever, and headache. Most of these side effects were low grade and of short duration.
The results of the study indicate that Provenge improved overall survival among men with metastatic, androgen-independent prostate cancer.
Reference: Dendreon press release. Data presented at AUA demonstrate PROVENGE significantly prolongs survival for men with advanced prostate cancer in pivotal phase 3 IMPACT study. Available at: http://investor.dendreon.com/releasedetail.cfm?ReleaseID=380042. Accessed April 28, 2009.
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