Safety evaluation of axicabtagene ciloleucel for relapsed or refractory large B-cell lymphoma

Expert Opin Drug Saf. 2023 Jan;22(1):5-15. doi: 10.1080/14740338.2023.2177268. Epub 2023 Feb 17.

Abstract

Introduction: CD19-directed chimeric antigen receptor (CAR) T-cell therapy is a highly effective therapy for patients with relapsed/refractory large B-cell lymphoma (LBCL) and three CD19 CAR T-cell products (axicabtagene ciloleucel, tisagenlecleucel and lisocabtagene maraleucel) are currently approved for this indication. Despite the clinical benefit of CD19 directed CAR T-cell therapy, this treatment is associated with significant morbidity from treatment-emergent toxicities.

Areas covered: This Review discusses the safety considerations of axicabtagene ciloleucel in patients with LBCL. This includes discussion of the frequently observed immune-mediated toxicities of cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome. Additionally, we review CAR T-cell therapy related cytopenias, infection, organ dysfunction and the more recently described hemophagocytic lymphohistiocytosis.

Expert opinion: A thorough understanding of the toxicities associated with CD19-directed CAR T-cell therapy will facilitate the optimal selection of patients for this therapy. Furthermore, knowledge of preventative measures of CAR T-cell related complications, and early recognition and appropriate intervention will lead to the safe administration of these therapies, and ultimately improved outcomes for our patients.

Keywords: Axicabtagene ciloleucel; chimeric antigen receptor (CAR) T-cell therapy; cytokine release syndrome (CRS); immune effector cell-associated neurotoxicity syndrome (ICANS); large B-cell lymphoma (LBCL).

Publication types

  • Review

MeSH terms

  • Antigens, CD19 / adverse effects
  • Humans
  • Immunotherapy, Adoptive / adverse effects
  • Lymphoma, Large B-Cell, Diffuse* / pathology
  • Lymphoma, Large B-Cell, Diffuse* / therapy
  • Receptors, Chimeric Antigen*
  • Treatment Outcome

Substances

  • axicabtagene ciloleucel
  • cell-associated neurotoxicity
  • Receptors, Chimeric Antigen
  • Antigens, CD19