Dr. Gomella Discusses the IMPACT Trial Survival Benefit

Leonard G. Gomella, MD
Published: Monday, May 21, 2012

Leonard G. Gomella, MD, Bernard W. Godwin Jr. professor of prostate cancer and chairman of the Department of Urology, director of Clinical Affairs, Jefferson Kimmel Cancer Center, discusses the overall survival benefit of the IMPACT trial, which examined the immunotherapy sipuleucel-T (Provenge) in men with advanced prostate cancer.

In the trial, antigen-presenting cells were extracted using leukapheresis and were either used to create sipuleucel-T or frozen until disease progression in patients on the placebo arm. Following the reactivation of the frozen cells, a new immunotherapy similar to sipuleucel-T was manufactured named APC8015F.

Of the 249 men in the control arm, 155 received APC8015F. Those receiving APC8015F demonstrated similar benefits to those receiving sipuleucel-T; however, these patients were grouped with the placebo arm, when the benefits were calculated.

Removing the patients that received APC8015F and comparing just the patients that received placebo alone to those receiving sipuleucel-T alone more than doubles the 4.1-month median survival benefit found in the IMPACT trial.

Leonard G. Gomella, MD, Bernard W. Godwin Jr. professor of prostate cancer and chairman of the Department of Urology, director of Clinical Affairs, Jefferson Kimmel Cancer Center, discusses the overall survival benefit of the IMPACT trial, which examined the immunotherapy sipuleucel-T (Provenge) in men with advanced prostate cancer.

In the trial, antigen-presenting cells were extracted using leukapheresis and were either used to create sipuleucel-T or frozen until disease progression in patients on the placebo arm. Following the reactivation of the frozen cells, a new immunotherapy similar to sipuleucel-T was manufactured named APC8015F.

Of the 249 men in the control arm, 155 received APC8015F. Those receiving APC8015F demonstrated similar benefits to those receiving sipuleucel-T; however, these patients were grouped with the placebo arm, when the benefits were calculated.

Removing the patients that received APC8015F and comparing just the patients that received placebo alone to those receiving sipuleucel-T alone more than doubles the 4.1-month median survival benefit found in the IMPACT trial.


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