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Sipuleucel-T immune parameters correlate with survival: an analysis of the randomized phase 3 clinical trials in men with castration-resistant prostate cancer
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Sipuleucel-T immune parameters correlate with survival: an analysis of the randomized phase 3 clinical trials in men with castration-resistant prostate cancer
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Journal Article
Sipuleucel-T immune parameters correlate with survival: an analysis of the randomized phase 3 clinical trials in men with castration-resistant prostate cancer
2013
Overview
Purpose
Sipuleucel-T, the first FDA-approved autologous cellular immunotherapy for treatment of advanced prostate cancer, is manufactured by activating peripheral blood mononuclear cells, including antigen presenting cells (APCs), with a fusion protein containing prostatic acid phosphatase. Analysis of data from three phase 3 trials was performed to immunologically characterize this therapy during the course of the three doses, and to relate the immunological responses to overall survival (OS).
Methods
Sipuleucel-T product characteristics [APC numbers, APC activation (CD54 upregulation), and total nucleated cell (TNC) numbers] were assessed in three randomized, controlled phase 3 studies (
N
= 737). Antigen-specific cellular and humoral responses were assessed in a subset of subjects. The relationships between these parameters and OS were assessed.
Results
APC activation occurred in the first dose preparation [6.2-fold, (4.65, 7.70); median (25th, 75th percentile)] and increased in the second [10.6-fold (7.83, 13.65)] and third [10.5-fold (7.89, 13.65)] dose preparations. Cytokines and chemokines associated with activated APCs were produced during the manufacture of each dose; T-cell activation-associated cytokines were detected in the second and third dose preparations. Antigen-specific T cells were detectable after administration of the first sipuleucel-T dose. Cumulative APC activation, APC number, and TNC number correlated with OS (
P
< 0.05). Antigen-specific immune responses were observed in 78.8 % of monitored subjects and their presence correlated with OS (
P
= 0.003).
Conclusion
Sipuleucel-T broadly engages the immune system by activating APCs ex vivo and inducing long-lived immune responses in vivo. These data indicate antigen-specific immune activation as a mechanism by which sipuleucel-T prolongs OS.
Publisher
Springer-Verlag,Springer Nature B.V
Subject
/ Aged
/ Antigen-Presenting Cells - drug effects
/ Antigen-Presenting Cells - immunology
/ Antigen-Presenting Cells - metabolism
/ Antigens
/ Humans
/ Lymphocyte Activation - drug effects
/ Lymphocyte Activation - immunology
/ Male
/ Medicine
/ Oncology
/ Original
/ Peripheral blood mononuclear cells
/ Prostatic Neoplasms - immunology
/ Prostatic Neoplasms - mortality
/ Prostatic Neoplasms - therapy
