Axi-Cel, Liso-Cel, and Tisa-Cel Show Comparable Real-World Survival Outcomes in DLBCL

CAR T-cell therapy in DLBCL |

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No statistically significant differences in overall survival (OS) were observed in patients with diffuse large B-cell lymphoma (DLBCL) who received treatment with tisagenlecleucel (tisa-cel; Kymriah), axicabtagene ciloleucel (axi-cel; Yescarta), or lisocabtagene maraleucel (liso-cel; Breyanzi) across FDA-approved indications (log-rank test: χ², 0.773; degrees of freedom [df], 1; P = .379), according to data from a retrospective, observational study presented at the 2025 European Hematology Association Congress.1

The hazard ratios between the axi-cel and tisa-cel, axi-cel and liso-cel, and tisa-cel and liso-cel cohorts were 0.903 (95% CI, 0.719-1.134), 1.065 (95% CI, 0.831-1.364), and 1.163 (95% CI, 0.856-1.582), respectively.

“This large-scale, real-world study provides valuable insights into mortality rates associated with three approved CAR T-cell therapies for refractory lymphomas over a three-year period. While mortality rates varied among therapies at different time points, survival analysis of [patients with] DLBCL revealed no statistically significant differences in overall survival outcomes,” presenting study author Vladimir Otasevic, MD, PhD, and coauthors wrote in the poster. Otasevic is an internal medicine specialist and associate medical director of Hematology at Parexel.

CAR T-cell therapy has become a standard of care for the treatment of patients with refractory lymphomas, with three FDA-approved products available for use: tisa-cel, axi-cel, and liso-cel.1,2 However, real-world data surrounding their performance in routine clinical care are lacking. As such, this study evaluated the mortality rates after CAR T-cell therapy infusion in real-world settings using a large electronic health records database.

Investigators used the TriNet global dataset, which houses the electronic health records of 228,062,680 patients. Data were pooled from patients with DLBCL who had received tisa-cel (n = 1140), axi-cel (n = 1850), or liso-cel (n = 440) across all indications over a 3-year period post infusion to determine whether there are statistically significant differences in OS between the 3 products.

All-cause mortality was evaluated at months 1, 3, 6, 12, and 36 after infusion. Kaplan-Meier survival analysis was performed to estimate survival outcomes in patients with DLBCL across the 3 therapies during the 3-year post treatment period. Data cutoff was February 19, 2025.

Additional data indicated that the cumulative all-cause mortality rates 1, 3, 6, 12, and 36 months after CAR T-cell therapy infusion with tisa-cel were 2.6%, 7.0%, 12.3%, 17.5%, and 23.7%, respectively. With axi-cel, these respective rates were 2.2%, 7.6%, 13.5%, 19.5%, and 24.5%. Respective rates with liso-cel were 2.3%, 4.5%, 11.4%, 15.9%, and 18.2%.

“These findings indicate consistent survival outcomes in real-world settings as observed in pivotal clinical trials. Future research should focus on identifying predictors of mortality and strategies to mitigate risks while maintaining therapeutic efficacy across different CAR T products,” the study authors wrote in their conclusion.

Disclosures: None were listed.

References

1. Maiti K, Otasevic V, Lunney N, D’Angelo K, Learn C, et al. Three-year real-world mortality analysis of CAR-T therapies: tisa-cel, axi-cel, and liso-cel. Presented at: 2025 European Hematology Association Congress; June 12-15, 2025; Milan, Italy. Abstract PS1930.
2. Approved cellular and gene therapy products. FDA. Updated May 15, 2025. Accessed June 17, 2025. https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products