Outcomes and factors impacting use of axicabtagene ciloleucel in patients with relapsed or refractory large B-cell lymphoma: results from an intention-to-treat analysis

Leuk Lymphoma. 2021 Jun;62(6):1344-1352. doi: 10.1080/10428194.2020.1864349. Epub 2020 Dec 29.

Abstract

Data on real-world outcomes of axicabtagene ciloleucel (axi-cel) therapy for relapsed/refractory large B-cell lymphoma (R/R LBCL) are limited. In this intent to treat (ITT) analysis, we reviewed records of 38 consecutive patients with R/R LBCL for whom axi-cel was intended. Twenty-seven (71%) patients received axi-cel and 11 (29%) did not. Patients in the non-axi-cel group had a higher hematopoietic cell transplantation comorbidity index (HCT-CI) (median 4 vs. 2, p = .04). Median overall survival for the ITT, axi-cel and non-axi-cel group was 10 (95% CI, 3.7 to 13), 13 (95% CI, 7.7 to N.R.) and 1 (95% CI, 0.4 to 3.7) month(s) respectively. Factors limiting axi-cel use were disease progression, sepsis, manufacturing failure and socioeconomic barrier in 6 (55%), 3 (27%), 1 (9%) and 1 (9%) patient(s) respectively. Additional strategies are needed to ensure all LBCL patients for whom chimeric antigen receptor (CAR) T-cell therapy is prescribed can receive this treatment.

Keywords: Axi-cel; CAR T-cell therapy; diffuse large B-cell lymphoma; letter of medical necessity.

MeSH terms

  • Antigens, CD19* / therapeutic use
  • Biological Products
  • Humans
  • Immunotherapy, Adoptive
  • Intention to Treat Analysis
  • Lymphoma, Large B-Cell, Diffuse* / drug therapy

Substances

  • Antigens, CD19
  • Biological Products
  • axicabtagene ciloleucel