Therapeutics and Clinical Risk Management (May 2018)

Axicabtagene ciloleucel (KTE-C19), an anti-CD19 CAR T therapy for the treatment of relapsed/refractory aggressive B-cell non-Hodgkin’s lymphoma

  • Jain MD,
  • Bachmeier CA,
  • Phuoc VH,
  • Chavez JC

Journal volume & issue
Vol. Volume 14
pp. 1007 – 1017

Abstract

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Michael D Jain,1,2 Christina A Bachmeier,3 Vania H Phuoc,2 Julio C Chavez,2,4 1Department of Blood and Marrow Transplantation and Cellular Immunotherapy, Moffitt Cancer Center, Tampa, FL, USA; 2Department of Oncologic Sciences, University of South Florida, Tampa, FL, USA; 3Department of Pharmacy, Moffitt Cancer Center, Tampa, FL, USA; 4Department of Malignant Hematology, Moffitt Cancer Center, Tampa, FL, USA Abstract: Adoptive T-cell immunotherapy is a rapidly growing field and is shifting the paradigm of clinical cancer treatment. Axicabtagene ciloleucel (axi-cel) is an anti-CD19 chimeric antigen receptor T-cell therapy that was initially developed at the National Cancer Institute and has recently been commercially approved by the US Food and Drug Administration for relapsed or refractory aggressive non-Hodgkin’s lymphomas including diffuse large B-cell lymphoma and its variants. The ZUMA-1 Phase I and II clinical trials formed the basis of the US Food and Drug Administration approval of this product, and we discuss the particulars of the clinical trials and the pharmacology of axi-cel. In addition, we review the CD19 chimeric antigen receptor T-specific toxicities of cytokine release syndrome and neurotoxicity, which remain the challenges to the safe delivery of this important therapy for aggressive B-cell lymphomas with poor prognosis. Keywords: axicabtagene ciloleucel, CAR T, non-Hodgkin’s lymphoma, immunotherapy

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