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Tisagenlecleucel in Adult Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Open accessAbstract
BACKGROUND: Patients with diffuse large B-cell lymphoma that is refractory to primary and second-line therapies or that has relapsed after stem-cell transplantation have a poor prognosis. The chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel targets and eliminates CD19-expressing B cells and showed efficacy against B-cell lymphomas in a single-center, phase 2a study. METHODS: We conducted an international, phase 2, pivotal study of centrally manufactured tisagenlecleucel involving adult patients with relapsed or refractory diffuse large B-cell lymphoma who were ineligible for or had disease progression after autologous hematopoietic stem-cell transplantation. The primary end point was the best overall response rate (i.e., the percentage of patients who had a complete or partial response), as judged by an independent review committee. RESULTS: A total of 93 patients received an infusion and were included in the evaluation of efficacy. The median time from infusion to data cutoff was 14 months (range, 0.1 to 26). The best overall response rate was 52% (95% confidence interval, 41 to 62); 40% of the patients had complete responses, and 12% had partial responses. Response rates were consistent across prognostic subgroups. At 12 months after the initial response, the rate of relapse-free survival was estimated to be 65% (79% among patients with a complete response). The most common grade 3 or 4 adverse events of special interest included cytokine release syndrome (22%), neurologic events (12%), cytopenias lasting more than 28 days (32%), infections (20%), and febrile neutropenia (14%). Three patients died from disease progression within 30 days after infusion. No deaths were attributed to tisagenlecleucel, cytokine release syndrome, or cerebral edema. No differences between response groups in tumor expression of CD19 or immune checkpoint-related proteins were found. CONCLUSIONS: In this international study of CAR T-cell therapy in relapsed or refractory diffuse large B-cell lymphoma in adults, high rates of durable responses were produced with the use of tisagenlecleucel. (Funded by Novartis; JULIET ClinicalTrials.gov number, NCT02445248 .).
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“These CAR T-cells were able to elicit complete responses (CR) in 32-67% of lymphoma patients and showed better CR rates in patients with leukemia (16-19).”
From Scalable Manufacturing of CAR T Cells for Cancer Immunotherapy (2021) · cites this paper as [17]
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“First, most CAR T cell trials to date have used autologous peripheral blood and apheresis as the main cell sources for manufacturing (9-18,21,22).”
From Scalable Manufacturing of CAR T Cells for Cancer Immunotherapy (2021) · cites this paper as [17]
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“However, despite high initial response rates, complete and long-term remission is only achieved in up to 40% of patients13–16.”
From A non-antibiotic-disrupted gut microbiome is associated with clinical responses to CD19-CAR-T cell cancer immunotherapy (2023) · cites this paper as [16]
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“Efficacy results seem similar in patients with LBCL treated with CD19 CAR T cells costimulated by 4-1BB instead of CD28, with or without fixing the ratio of CD4:CD8 cells.”
From Tumor interferon signaling and suppressive myeloid cells are associated with CAR T-cell failure in large B-cell lymphoma (2021) · cites this paper as [5]
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Metadata
- Authors
- Schuster, S. J., Bishop, M. R., Tam, C. S., Waller, E. K., Borchmann, P., McGuirk, J. P., Jäger, U., Jaglowski, S., Andreadis, C., Westin, J. R., Fleury, I., Bachanova, V., Foley, S. R., Ho, P. J., Mielke, S., Magenau, J. M., Holte, H., Pantano, S., Pacaud, L. B., Awasthi, R., Chu, J., Anak, Ö., Salles, G., & Maziarz, R. T.
- Affiliations
- The University of Sydney (AU)
- From the Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.J.S.); the Hematopoietic Cellular Therapy Program, University of Chicago Medicine, Chicago (M.R.B.); Peter MacCallum Cancer Centre, St. Vincent’s Hospital and University of Melbourne, Melbourne, VIC (C.S.T.), and the Royal Prince Alfred Hospital and Department of Medicine, University of Sydney, Sydney (P.J.H.) — both in Australia; Winship Cancer Institute of Emory University, Bone Marrow and Stem Cell...
- Oslo University Hospital (NO)
- Novartis (Switzerland) (CH)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2019-01-03
- Volume
- 380
- Issue
- 1
- Pages
- 45-56
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2903062212
- Cited by
- 4,112
- References
- 29
- Citations by year
- 2026: 363 · 2025: 507 · 2024: 593 · 2023: 593 · 2022: 693 · 2021: 624 · 2020: 502 · 2019: 218
- FWCI
- 125.46
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Kölner Universitäts PublikationsServer (Universität zu Köln) (publishedVersion)
- Pure Amsterdam UMC (publishedVersion, cc-by)
- Data Archiving and Networked Services (DANS) (submittedVersion, other-oa)
- HAL (submittedVersion)
- Funders
- Novartis Pharmaceuticals Corporation
- Topics
- Health Sciences › Medicine › Oncology › CAR-T cell therapy research
- Health Sciences › Medicine › Pathology and Forensic Medicine › Lymphoma Diagnosis and Treatment
- Life Sciences › Immunology and Microbiology › Immunology › T-cell and B-cell Immunology
- Keywords
- tisagenlecleucel, CAR T-cell therapy, diffuse large B-cell lymphoma, relapsed/refractory lymphoma, CD19, autologous stem cell transplantation, cytokine release syndrome, neurological adverse events, relapse-free survival, complete response, immune checkpoint molecules
- MeSH terms
- Receptors, Chimeric Antigen, Progression-Free Survival, Adult, Aged, Female, Humans, Male, Middle Aged, Receptors, Antigen, T-Cell, Recurrence, Survival Analysis, Immunotherapy, Adoptive, Lymphoma, Large B-Cell, Diffuse, Young Adult, Neoplasm Grading
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