ORLANDO, FL, USA (UroToday.com) - Sipuleucel-T is an autologous cellular immunotherapy designed to stimulate an immune response against prostate cancer and is approved by the FDA for asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer (mCRPC). Sipuleucel-T improved overall survival compared with placebo in the phase 3 IMPACT study.
Abiraterone acetate is a CYP17 inhibitor and is approved by the FDA for mCRPC. It suppresses circulating androgen levels, which has been shown to be immunostimulatory. Therefore, the combination of sipuleucel-T and abiraterone acetate may be synergistic. However, abiraterone acetate is co-administered with prednisone, which has immunosuppressive effects and could theoretically impair production of and/or blunt the immunologic response to sipuleucel-T
P11-3 (NCT01487863) is an ongoing, randomized, open-label, phase 2 study and is the fi rst study of the combination of sipuleucel-T and abiraterone acetate plus prednisone in patients with mCRPC. This poster presents an interim analysis of sipuleucel-T product characteristics, immune response, and safety in patients participating in P11-3....Click here to enlarge and view the poster
Presented by Eric J. Small,* Raymond Lance, Thomas A. Gardner, Lawrence Ivan Karsh, Andrew Stubbs, Candice McCoy, Todd DeVries, Charles H. Redfern, and Neal D. Shore at the 2013 Genitourinary Cancers Symposium - February 14 - 16, 2013 - Rosen Shingle Creek - Orlando, Florida USA
*University of California, San Francisco, San Francisco, CA; Eastern Virginia Medical School, Norfolk, VA; Indiana University School of Medicine, Indianapolis, IN; The Urology Center of Colorado, Denver, CO; Dendreon, Denver, CO; Dendreon Corporation, Seattle, WA; Oncology Associates of San Diego, San Diego, CA; Carolina Urologic Research Center, Myrtle Beach, SC
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