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R. B. Sims, N. M. Provost, D. L. Urdal, Y. Xu, M. W. Frohlich
Abstract:
Introduction: Sipuleucel-T is an investigational active cellular immunotherapy designed to stimulate an immune response against prostate cancer. To prepare sipuleucel-T, fresh mononuclear cells are isolated from a patient's peripheral blood leukapheresis component. The cells are pulsed with a recombinant fusion protein (PA2024). Key sipuleucel-T product release parameters include CD54 upregulation (the ratio of CD54 expression pre versus post incubation with PA2024, a measure of product potency), total nucleated cells (TNC), and the total number of CD54+ cells. Methods: Cumulative product release parameters (calculated by summing the relevant product parameter over all three infusions for each patient) were evaluated for patients treated with sipuleucel-T (n=146) in 2 Phase 3 trials, D9901 and D9902A. Correlation with survival was explored for the 3 cumulative product release parameters using simple Cox proportional hazards ratio (PHR) models. A multivariate Cox PHR model was used to determine whether these product release parameters correlated with survival when adjusting for 5 key prognostic variables. Results: The results shown in the table indicate a positive correlation with survival for CD54 upregulation ratio and TNC count. This correlation remains strong for CD54 upregulation ratio after adjusting for baseline prognostic factors. Conclusions: These data suggest that patients treated with sipuleucel-T experienced improved survival if they generated higher cumulative TNC numbers or higher cumulative CD54 upregulation values. The effect of CD54 upregulation appears to be independent of patient baseline prognostic factors. These results are the first evidence correlating product potency with survival for an active cellular immunotherapy, and may contribute to the understanding of the product's mechanism of action.
Survival and Product Parameters
Unadjusted
Adjusted*
Variable (cumulative, all infusions)
N
p-value
N
p-value
CD54 upregulation
146
0.009
134
0.022
Total nucleated cell number
146
0.019
134
0.138
CD54+ cell number
146
0.354
134
0.694
*Adjusted for baseline PSA, metastatic bone lesion count, localization of disease, LDH, and weight.
Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy
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Associated Presentation(s):
1. Cell number and CD54 expression in sipuleucel-T correlate with survival in metastatic androgen independent prostate cancer
Associated Presentation(s):