What is the role of axicabtagene ciloleucel (Yescarta) in the treatment of non-Hodgkin lymphoma/B-cell lymphoma?

Updated: Feb 23, 2021
  • Author: Mohammad Muhsin Chisti, MD, FACP; Chief Editor: Emmanuel C Besa, MD  more...
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Answer

In 2017, the US Food and Drug Administration (FDA) approved axicabtagene ciloleucel (Yescarta), a CD19-directed CAR T-cell therapy, for relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after at least two other lines of systemic treatment have failed. It is not indicated for the treatment of patients with primary central nervous system lymphoma.

FDA approval was based on results from the ZUMA-1 study, an open-label, multicenter trial that enrolled 111 patients from 22 institutions. Study patients received the target dose of axicabtagene ciloleucel (2 × 106 cells/kg) after low-dose conditioning with cyclophosphamide and fludarabine for 3 days. The modified intention-to-treat population involved 101 patients who received axicabtagene ciloleucel. In adults with R/R DLBCL, the response rates were approximately 60-80%, with complete responses seen in 40-70% of patients. After receiving axicabtagene ciloleucel, 40% of patients maintained their complete response at 6-month follow-up. [18, 19]

The trial had a median survival follow-up of 8.7 months. Common adverse reactions included cytokine release syndrome, hypotension, encephalopathy and febrile neutropenia. In addition, prolonged cytopenias, hypogammaglobulinemia, and serious infections can occur. [18]


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