# Real-World Outcomes of Axicabtagene Ciloleucel for Treatment of Relapsed or Refractory Large B-Cell Lymphoma in Canada

## TL;DR

This study shows that axicabtagene ciloleucel is effective and safe for treating a type of aggressive lymphoma in real-world Canadian patients.

## Contribution

The study provides real-world evidence of axi-cel's effectiveness and safety in a Canadian context.

## Key findings

- Axi-cel achieved a 77% objective response rate and 59% complete response rate in patients.
- At 12 months, 49% of patients were progression-free and 59% were alive.
- Adverse events were less severe compared to clinical trials and other real-world reports.

## Abstract

Axicabtagene ciloleucel (axi-cel) is a type of chimeric antigen receptor T (CAR T)-cell therapy approved in Canada to treat adults with relapsed or refractory large B cell lymphoma, which is usually associated with a poor prognosis. In this retrospective study, we analyzed data from a large national registry database to evaluate the real-world effectiveness and safety outcomes of axi-cel across multiple Canadian centres. Our findings demonstrated that the effectiveness of axi-cel was comparable to those reported in clinical trial and real-world studies, with lower rates of adverse events. These findings support the ongoing use of axi-cel for the treatment of R/R LBCL in Canada.

CD19 CAR T-cell therapy has significantly improved the survival of patients with relapsed or refractory large B cell lymphoma (R/R LBCL) and is considered standard of care for eligible patients in Canada. Axicabtagene ciloleucel (axi-cel) is an autologous CAR T-cell therapy, initially approved by Health Canada for adults with R/R LBCL after 2 or more lines of therapy. This multi-centre analysis, with registry data collected from CIBMTR, aims to present a Canadian perspective on the real-world experience of axi-cel in patients with R/R LBCL. With a median follow-up of 12.4 months, the best objective response rate (ORR) and complete response (CR) rate among all patients were 77% and 59%, respectively. At 12 months, estimated progression-free survival (PFS) and overall survival (OS) were 49% and 59%, respectively. Notably, the incidence and severity of adverse events were lower in this cohort compared to ZUMA-1 and other real-world reports, with CRS occurring in 77% (grade ≥ 3, 3%) and ICANS occurring in 38% (grade ≥ 3, 10%) of patients. Outcomes remained largely consistent across patient and disease characteristics. These findings demonstrate effectiveness and safety profiles comparable to international real-world studies and the ZUMA-1 trial, supporting the use of axi-cel as an effective treatment across broad Canadian populations.