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Second-line tisagenlecleucel or standard care in aggressive B-cell lymphoma

Item Type:Article
Title:Second-line tisagenlecleucel or standard care in aggressive B-cell lymphoma
Creators Name:Bishop, M.R. and Dickinson, M. and Purtill, D. and Barba, P. and Santoro, A. and Hamad, N. and Kato, K. and Sureda, A. and Greil, R. and Thieblemont, C. and Morschhauser, F. and Janz, M. and Flinn, I. and Rabitsch, W. and Kwong, Y.L. and Kersten, M.J and Minnema, M.C. and Holte, H. and Chan, E.H.L. and Martinez-Lopez, J. and Müller, A.M.S. and Maziarz, R.T. and McGuirk, J.P. and Bachy, E. and Le Gouill, S. and Dreyling, M. and Harigae, H. and Bond, D. and Andreadis, C. and McSweeney, P. and Kharfan-Dabaja, M. and Newsome, S. and Degtyarev, E. and Awasthi, R. and Del Corral, C. and Andreola, G. and Masood, A. and Schuster, S.J. and Jäger, U. and Borchmann, P. and Westin, J.R.
Abstract:BACKGROUND: Patient outcomes are poor for aggressive B-cell non-Hodgkin's lymphomas not responding to or progressing within 12 months after first-line therapy. Tisagenlecleucel is an anti-CD19 chimeric antigen receptor T-cell therapy approved for diffuse large B-cell lymphoma after at least two treatment lines. METHODS: We conducted an international phase 3 trial involving patients with aggressive lymphoma that was refractory to or progressing within 12 months after first-line therapy. Patients were randomly assigned to receive tisagenlecleucel with optional bridging therapy (tisagenlecleucel group) or salvage chemotherapy and autologous hematopoietic stem-cell transplantation (HSCT) (standard-care group). The primary end point was event-free survival, defined as the time from randomization to stable or progressive disease at or after the week 12 assessment or death. Crossover to receive tisagenlecleucel was allowed if a defined event occurred at or after the week 12 assessment. Other end points included response and safety. RESULTS: A total of 322 patients underwent randomization. At baseline, the percentage of patients with high-grade lymphomas was higher in the tisagenlecleucel group than in the standard-care group (24.1% vs. 16.9%), as was the percentage with an International Prognostic Index score (range, 0 to 5, with higher scores indicating a worse prognosis) of 2 or higher (65.4% vs. 57.5%). A total of 95.7% of the patients in the tisagenlecleucel group received tisagenlecleucel; 32.5% of the patients in the standard-care group received autologous HSCT. The median time from leukapheresis to tisagenlecleucel infusion was 52 days. A total of 25.9% of the patients in the tisagenlecleucel group had lymphoma progression at week 6, as compared with 13.8% of those in the standard-care group. The median event-free survival in both groups was 3.0 months (hazard ratio for event or death in the tisagenlecleucel group, 1.07; 95% confidence interval, 0.82 to 1.40; P = 0.61). A response occurred in 46.3% of the patients in the tisagenlecleucel group and in 42.5% in the standard-care group. Ten patients in the tisagenlecleucel group and 13 in the standard-care group died from adverse events. CONCLUSIONS: Tisagenlecleucel was not superior to standard salvage therapy in this trial. Additional studies are needed to assess which patients may obtain the most benefit from each approach. (Funded by Novartis; BELINDA ClinicalTrials.gov number, NCT03570892.).
Source:New England Journal of Medicine
ISSN:0028-4793
Publisher:Massachusetts Medical Society
Date:14 December 2021
Official Publication:https://doi.org/10.1056/NEJMoa2116596
PubMed:View item in PubMed

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