ORLANDO, FL, USA (UroToday.com) - Sipuleucel-T is an autologous cellular immunotherapy approved by the US FDA for the treatment of asymptomatic or minimally symptomatic mCRPC.
Sipuleucel-T is prepared by culturing isolated peripheral blood mononuclear cells (PBMCs) with 10μg/mL PA2024, a recombinant protein comprising prostatic acid phosphatase (PAP) fused to granulocyte-macrophage colony-stimulating factor (GM-CSF). Sipuleucel-T produced with 10μg/mL PA2024 has been shown to stimulate immune responses and prolong overall survival (OS) in patients with mCRPC2 –– the Phase 3 study IMPACT showed sipuleucel-T reduced the risk of death by 22.5% (HR=0.78; p=0.032) and increased median OS by 4.1 months, compared with control.
ProACT (NCT00715078) is an ongoing, randomized, single-blind, Phase 2 study designed to evaluate immune responses and OS in patients with mCRPC treated with sipuleucel-T manufactured using three different concentrations of PA2024: 2, 5 and 10μg/mL; the concentration used in previous sipuleucel-T clinical trials; and the FDA-approved concentration is 10μg/mL.
Here we present the immune response in patients with mCRPC who have been treated with sipuleucel-T manufactured using the FDA approved concentration of 10μg/mL PA2024. Analyses of immune response following treatment with sipuleucel-T manufactured with the lower antigen concentrations will be presented in future publications....Click here to enlarge and view the poster.
Presented by Thomas A. Gardner,1 Daniel Peter Petrylak,2 John M. Corman,3 Simon Hall,4 Ralph Weinstein,5 Robert Keyser,6 Robert Brownell Sims,6 Amanda Sanders,6 Nadeem A. Sheikh,6 and Celestia S. Higano7 at the 2013 Genitourinary Cancers Symposium - February 14 - 16, 2013 - Rosen Shingle Creek - Orlando, Florida USA
1Urology Indiana University Health, Indianapolis, IN, USA; 2Columbia University Medical Center, New York, NY, USA; 3Virginia Mason Medical Center, Seattle, WA, USA; 4Mount Sinai School of Medicine, New York, NY, USA; 5US Oncology, Portland, OR, USA; 6Dendreon Corporation, Seattle, WA, USA; 7School of Medicine, University of Washington, Seattle, WA, USA