Comparative efficacy and toxicity of Axicabtagene Ciloleucel versus Tisagenlecleucel in European patients with large B-cell lymphoma: a systematic review and meta-analysis.
Large B-cell lymphoma (LBCL) is a common and aggressive non-Hodgkin lymphoma (NHL) characterized by abnormal proliferation of mature B lymphocytes, with a 10-year prevalence of up to 45 cases per 100,000 individuals in European populations and a continuing upward trend. Axicabtagene ciloleucel (Axi-cel) and Tisagenlecleucel (Tisa-cel) are the two most established chimeric antigen receptor T-cell (CAR-T) therapy products for LBCL, yet a systematic comparison of their efficacy and safety in European populations has been lacking. This systematic review and meta-analysis aims to address this gap by comprehensively evaluating differences in treatment efficacy and adverse events between Axi-cel and Tisa-cel in European patients with LBCL.
We searched PubMed, Cochrane Library, Scopus, and other databases for studies published between January 2020 and February 2026, ultimately including eight European cohort studies with a total of 2,178 patients. Efficacy and survival outcomes comprised 3-month overall response (OR), 3-month complete response (CR), 12-month progression-free survival (PFS), and 12-month overall survival (OS). Toxicity outcomes included 12-month non-relapse mortality (NRM), all-grade and grade ≥ 3 cytokine release syndrome (CRS), all-grade and grade ≥ 3 immune effector cell-associated neurotoxicity syndrome (ICANS), all-grade and grade ≥ 3 neutropenia, thrombocytopenia, and anemia, as well as tocilizumab use and ICU support. A random-effects model was used for pooled analysis, with sensitivity analyses performed for outcomes exhibiting substantial heterogeneity.
Regarding efficacy, Axi-cel was associated with significantly higher 3-month OR and 3-month CR rates compared with Tisa-cel, whereas 12-month PFS was lower in the Axi-cel group. In terms of toxicity, the incidences of all-grade CRS, all-grade ICANS, and grade ≥ 3 ICANS were significantly higher with Axi-cel, and tocilizumab use was more frequent. No statistically significant differences were observed for the remaining outcomes.
In European patients with LBCL, Axi-cel demonstrated superior short-term efficacy compared with Tisa-cel, but showed inferior performance on certain intermediate-term efficacy endpoints and was generally associated with greater toxicity and higher healthcare resource utilization. Clinical selection of a CAR-T regimen should be individualized, with careful consideration of efficacy, toxicity, and cost. Future high-quality studies with longer follow-up are needed to evaluate long-term outcomes and to validate the findings of this analysis.
We searched PubMed, Cochrane Library, Scopus, and other databases for studies published between January 2020 and February 2026, ultimately including eight European cohort studies with a total of 2,178 patients. Efficacy and survival outcomes comprised 3-month overall response (OR), 3-month complete response (CR), 12-month progression-free survival (PFS), and 12-month overall survival (OS). Toxicity outcomes included 12-month non-relapse mortality (NRM), all-grade and grade ≥ 3 cytokine release syndrome (CRS), all-grade and grade ≥ 3 immune effector cell-associated neurotoxicity syndrome (ICANS), all-grade and grade ≥ 3 neutropenia, thrombocytopenia, and anemia, as well as tocilizumab use and ICU support. A random-effects model was used for pooled analysis, with sensitivity analyses performed for outcomes exhibiting substantial heterogeneity.
Regarding efficacy, Axi-cel was associated with significantly higher 3-month OR and 3-month CR rates compared with Tisa-cel, whereas 12-month PFS was lower in the Axi-cel group. In terms of toxicity, the incidences of all-grade CRS, all-grade ICANS, and grade ≥ 3 ICANS were significantly higher with Axi-cel, and tocilizumab use was more frequent. No statistically significant differences were observed for the remaining outcomes.
In European patients with LBCL, Axi-cel demonstrated superior short-term efficacy compared with Tisa-cel, but showed inferior performance on certain intermediate-term efficacy endpoints and was generally associated with greater toxicity and higher healthcare resource utilization. Clinical selection of a CAR-T regimen should be individualized, with careful consideration of efficacy, toxicity, and cost. Future high-quality studies with longer follow-up are needed to evaluate long-term outcomes and to validate the findings of this analysis.