Real-world outcomes with tisagenlecleucel in aggressive B-cell lymphoma: subgroup analyses from the CIBMTR registry

This real-world study of tisagenlecleucel for patients with R/R DLBCL/HGBCL shows consistent efficacy and better safety outcomes than the pivotal trial. This study also identifies baseline disease characteristics and prior or concurrent treatments that may affect clinical outcomes.Tisagenlecleucel, a CD19 chimeric antigen receptor T-cell therapy, is approved for adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBCL) after ≥2 lines of therapy. When used in real-world settings, tisagenlecleucel has shown similar efficacy and improved safety compared with previous clinical trials. However, long-term data on real-world outcomes are lacking.Clinical data from a cohort of patients treated with tisagenlecleucel in a real-world setting were captured in the Center for International Blood and Marrow Transplant Research registry. The main clinical outcomes analysed included response rate, duration of response, survival, adverse events, and clinicopathologic and treatment characteristics that may affect those outcomes.As of May 2022, 1159 patients with R/R DLBCL/HGBCL received tisagenlecleucel. The overall response rate was 59.5%, and the complete response rate was 44.5%. With a median follow-up of 23.2 months in the efficacy set (n=968), the 24 month rates of progression-free survival, ongoing response, and overall survival were 28.4%, 52.6%, and 43.6%, respectively. Grade ≥3 cytokine release syndrome and neurotoxicity were reported in 6% and 7.4% of patients, respectively. Patients with DLBCL (vs HGBCL), complete response before infusion, prior autologous or allogeneic haematopoietic stem cell transplant, and lactate dehydrogenase (LDH) within normal limits experienced more favourable efficacy outcomes, and those with Eastern Cooperative Oncology Group performance status ≥2, ≥3 prior lines of therapy, elevated LDH, and fludarabine-based lymphodepleting chemotherapy experienced less favourable safety outcomes.In conclusion, this real-world study of tisagenlecleucel for patients with R/R DLBCL/HGBCL shows consistent efficacy and better safety outcomes than the pivotal trial. This study also identifies baseline disease characteristics and prior or concurrent treatments that may affect clinical outcomes.

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Publication Details

Journal
Journal for ImmunoTherapy of Cancer
Published
2025-02-01
DOI
https://doi.org/10.1136/jitc-2024-009890
Citations
8
Primary Topic
CAR-T cell therapy research
Type
article
Field-Weighted Citation Impact
8.36

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article

Real-world outcomes with tisagenlecleucel in aggressive B-cell lymphoma: subgroup analyses from the CIBMTR registry

Leslie Popplewell, Peter A. Riedell, Brian T. Hill, Marta Majdan et al.
8 citations
Journal for ImmunoTherapy of Cancer
CAR-T cell therapy research
8.36
article

Real-world outcomes with tisagenlecleucel in aggressive B-cell lymphoma: subgroup analyses from the CIBMTR registry

Leslie Popplewell, Peter A. Riedell, Brian T. Hill, Marta Majdan, Grant Schofield, Frederick Lundry Locke, Gunjan L. Shah, Caron Alyce Jacobson, Daniel J. Landsburg, Ron Ram, Ranjan Tiwari, Aisha Masood, Matthew J. Frigault, Samantha Jaglowski, S.R. Foley, Michael Heim, Marcelo C. Pasquini, Cameron J. Turtle, Stephen Lim
article en
8 citations

Abstract

This real-world study of tisagenlecleucel for patients with R/R DLBCL/HGBCL shows consistent efficacy and better safety outcomes than the pivotal trial. This study also identifies baseline disease characteristics and prior or concurrent treatments that may affect clinical outcomes.Tisagenlecleucel, a CD19 chimeric antigen receptor T-cell therapy, is approved for adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBCL) after ≥2 lines of therapy. When used in real-world settings, tisagenlecleucel has shown similar efficacy and improved safety compared with previous clinical trials. However, long-term data on real-world outcomes are lacking.Clinical data from a cohort of patients treated with tisagenlecleucel in a real-world setting were captured in the Center for International Blood and Marrow Transplant Research registry. The main clinical outcomes analysed included response rate, duration of response, survival, adverse events, and clinicopathologic and treatment characteristics that may affect those outcomes.As of May 2022, 1159 patients with R/R DLBCL/HGBCL received tisagenlecleucel. The overall response rate was 59.5%, and the complete response rate was 44.5%. With a median follow-up of 23.2 months in the efficacy set (n=968), the 24 month rates of progression-free survival, ongoing response, and overall survival were 28.4%, 52.6%, and 43.6%, respectively. Grade ≥3 cytokine release syndrome and neurotoxicity were reported in 6% and 7.4% of patients, respectively. Patients with DLBCL (vs HGBCL), complete response before infusion, prior autologous or allogeneic haematopoietic stem cell transplant, and lactate dehydrogenase (LDH) within normal limits experienced more favourable efficacy outcomes, and those with Eastern Cooperative Oncology Group performance status ≥2, ≥3 prior lines of therapy, elevated LDH, and fludarabine-based lymphodepleting chemotherapy experienced less favourable safety outcomes.In conclusion, this real-world study of tisagenlecleucel for patients with R/R DLBCL/HGBCL shows consistent efficacy and better safety outcomes than the pivotal trial. This study also identifies baseline disease characteristics and prior or concurrent treatments that may affect clinical outcomes.

Journal for ImmunoTherapy of CancerVol. 13(2)
Roswell Park Comprehensive Cancer Center (US), The University of Sydney (AU), City Of Hope National Medical Center (US), Cleveland Clinic (US), Memorial Sloan Kettering Cancer Center (US), Tel Aviv University (IL), Medical College of Wisconsin (US), Tel Aviv Sourasky Medical Center (IL), Royal North Shore Hospital (AU), Juravinski Hospital (CA), Moffitt Cancer Center (US), University of Chicago (US), Massachusetts General Hospital (US), Fred Hutch Cancer Center (US), Novartis (India) (IN), Novartis (United States) (US), Dana-Farber/Harvard Cancer Center (US), The Ohio State University (US), University of Pennsylvania (US), McMaster University (CA)
U.S. Department of Defense, Be The Match Foundation, Amgen, Bristol-Myers Squibb, Pfizer, Astellas Pharma US, AstraZeneca, GlaxoSmithKline, Merck, Sanofi, Stanford University, Gilead Sciences, AbbVie, HistoGenetics, Boston Children's Hospital, Dana-Farber Cancer Institute, Novartis Pharmaceuticals Corporation, CSL Behring, StemCyte, Medical College of Wisconsin, Actinium Pharmaceuticals, Vertex Pharmaceuticals, Jazz Pharmaceuticals, TG Therapeutics, Anthem Foundation, Mallinckrodt Pharmaceuticals, Atara Biotherapeutics, Kyowa Kirin Pharmaceutical Development, CareDx, bluebird bio, Adaptive Biotechnologies, BeiGene, Incyte, Omeros Corporation, Kiadis Pharma, Astellas Pharma, Swedish Orphan Biovitrum, MorphoSys, Medac, National Institutes of Health, Health Resources and Services Administration, U.S. Navy, Takeda Oncology, Pharmacyclics, Legend Biotech, National Heart, Lung, and Blood Institute, Office of Naval Research, National Cancer Institute, National Institute of Allergy and Infectious Diseases, Janssen Research and Development
Good health and well-being
Openalex Percentile: Top 2%
CAR-T cell therapy research
8.36
DOIOpen Access PDFOpenAlex
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