Advanced prostate cancer therapy Provenge seeks marketing nod in US

Prostate cancer is the number one non-skin cancer in the United States. More than one million men in the United States have prostate cancer, with an estimated 220,000 new cases of prostate cancer diagnosed each year. More than 30,000 men die each year from the disease. 

The final three-year follow up of the D9901 Phase 3 study of Provenge in 127 men with asymptomatic, metastatic, androgen-independent prostate cancer showed a median survival benefit of 21 percent or 4.5 months and a three-fold improvement in survival at 36 months (p-value = 0.01; hazard ratio = 1.7) for patients who were randomized to receive Provenge compared to placebo. This hazard ratio implies that patients who received placebo have a 70 percent greater relative risk of dying than patients who received Provenge. 

Final three-year follow up of the D9902A Phase 3 study of Provenge in 98 men with asymptomatic, metastatic, androgen-independent prostate cancer showed a 20 percent improvement in median survival for patients who were randomized to receive Provenge compared to placebo. In addition, at the three-year final follow up, the percentage of patients alive in the Provenge-treated group was substantially greater than the percentage of patients alive who received placebo. 

In both studies, as in previous studies, Provenge was well tolerated with the most common adverse events reported being fever and chills lasting for one to two days, the company said in an official release.

Provenge is designed to stimulate a patient's immune system against prostate cancer. 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 phase 3 study in asymptomatic, metastatic, androgen-independent prostate cancer (D9902B). It is also being evaluated in a phase 3 trial, known as PROTECT or P-11, in men with earlier stage prostate cancer. 

Dendreon Corporation is a biotechnology company. In addition to its immunotherapies in clinical and preclinical development for a variety of cancers, Dendreon's product pipeline also includes monoclonal antibody and small molecule product candidates. Dendreon has research and development alliances with Genentech, Inc., Abgenix, Inc. and Dyax Corp. 

BY OUR PHARMA CORRESPONDENT