Abstract
Sipuleucel-T is an autologous active cellular immunotherapy used in the treatment of men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (CRPC). It is the first therapeutic cancer vaccine to receive US FDA approval.
Approximately 3 days prior to each infusion of sipuleucel-T, patients undergo a leukapheresis procedure for collection of autologous peripheral blood mononuclear cells. Preparation of sipuleucel-T involves enrichment for antigen-presenting cells from the leukapheresis product and activation ex vivo with a recombinant fusion protein (PA2024).
In the randomized, double-blind, placebo-controlled IMPACT study in patients with metastatic CRPC, sipuleucel-T was associated with a 22% relative reduction in the risk of death (hazard ratio 0.78; p = 0.03), which was the primary endpoint of the trial. After a median follow-up period of 34.1 months, median survival was 4.1 months longer with sipuleucel-T than placebo (25.8 vs 21.7 months). There was no significant between-group difference for the median time to objective disease progression (a secondary endpoint).
Almost all patients treated with sipuleucel-T in clinical trials reported an adverse event, although these were mild or moderate in severity (grade 1 or 2) in most patients. The most common adverse events (e.g. infusion-related events, such as chills and fever) generally occurred within the first day after administration of sipuleucel-T and resolved within 2 days.
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Acknowledgments and Disclosures
The manuscript was reviewed by: G. Di Lorenzo, Department of Molecular and Clinical Endocrinology and Oncology, University degli Studi Federico II, Naples, Italy; E.Y. Yu, Division of Oncology, University of Washington School of Medicine, Seattle Cancer Care Alliance, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.
The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was also offered an opportunity to comment on this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.
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Plosker, G.L. Sipuleucel-T. Drugs 71, 101–108 (2011). https://doi.org/10.2165/11206840-000000000-00000
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DOI: https://doi.org/10.2165/11206840-000000000-00000