Immunotherapy shows 52% improvement in survival in advanced PCa

Patients with advanced prostate cancer taking sipuleucel-T (Provenge), an investigational active cellular immunotherapy, have shown extended survival versus those receiving placebo in a second phase III study. The results are consistent with results from the first phase III study of the agent.

"The combined data from the trials versus placebo demonstrate that active immunotherapy favorably impacts survival in men with asymptomatic, metastatic, and androgen-independent prostate cancer," said researcher Celestia S. Higano, MD, of the University of Washington, Seattle. "Given the favorable side effect profile, sipuleucel-T may provide a useful alternative for men prior to initiating chemotherapy."

The 3-year survival analysis in 98 men showed those patients who received sipuleucel-T had a 19-month median survival time compared with 15.7 months for patients who were randomized to placebo, representing a 21% improvement. At the 3-year final follow-up, 32% of men in the sipuleucel-T group were alive compared with 21% of the men in the placebo group, a 52% improvement in the survival rate.

The therapy was well tolerated, with the most common adverse events being fever and chills lasting for 1 or 2 days.