An overview of sipuleucel-T: Autologous cellular immunotherapy for prostate cancer

Abstract

Sipuleucel-T, the first autologous active cellular immunotherapy approved by the United States Food and Drug Administration, is designed to stimulate an immune response to prostate cancer. Sipuleucel-T is manufactured by culturing a patient’s peripheral blood mononuclear cells (including antigen presenting cells) with a recombinant protein comprising a tumor-associated antigen (prostatic acid phosphatase) and granulocyte-macrophage colony stimulating factor. Treatment consists of 3 infusions at approximately 2-week intervals, resulting in a prime-boost pattern of immune activation, a robust antigen-specific cellular and humoral immune response, and, consequently, a survival benefit in subjects with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer. Adverse events are generally mild to moderate and resolve within 2 d. Serious adverse events occur at a low rate. As the first autologous cellular immunotherapy to demonstrate a survival benefit, sipuleucel-T is a novel oncologic therapeutic that warrants the reassessment of the current prostate cancer treatment paradigm.

Keywords: :

• active cellular therapy
• autologous cellular therapy
• immunotherapy
• prostate cancer
• sipuleucel-T

Acknowledgments

The authors wish to thank the subjects and their families, the participating study sites, the clinical investigators, and the contributions of current and former Dendreon personnel in the conduct of these clinical studies. Brandon Walsh, PhD, provided writing assistance in the preparation of this manuscript.