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| Item Type: | Article |
|---|---|
| Title: | Second-line tisagenlecleucel or standard care in aggressive B-cell lymphoma |
| Creators Name: | Bishop, M.R., Dickinson, M., Purtill, D., Barba, P., Santoro, A., Hamad, N., Kato, K., Sureda, A., Greil, R., Thieblemont, C., Morschhauser, F., Janz, M., Flinn, I., Rabitsch, W., Kwong, Y.L., Kersten, M.J, Minnema, M.C., Holte, H., Chan, E.H.L., Martinez-Lopez, J., Müller, A.M.S., Maziarz, R.T., McGuirk, J.P., Bachy, E., Le Gouill, S., Dreyling, M., Harigae, H., Bond, D., Andreadis, C., McSweeney, P., Kharfan-Dabaja, M., Newsome, S., Degtyarev, E., Awasthi, R., Del Corral, C., Andreola, G., Masood, A., Schuster, S.J., Jäger, U., 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.). |
| Keywords: | Adoptive Immunotherapy, Antineoplastic Combined Chemotherapy Protocols, Autologous Transplantation, Chimeric Antigen Receptors, Combined Modality Therapy, Diffuse Large B-Cell Lymphoma, Hematopoietic Stem Cell Transplantation, Immunological Antineoplastic Agents, Progression-Free Survival, Salvage Therapy, T-Cell Antigen Receptors |
| Source: | New England Journal of Medicine |
| ISSN: | 0028-4793 |
| Publisher: | Massachusetts Medical Society |
| Volume: | 386 |
| Number: | 7 |
| Page Range: | 629-639 |
| Date: | 17 February 2022 |
| Additional Information: | Copyright © 2021 Massachusetts Medical Society |
| Official Publication: | https://doi.org/10.1056/NEJMoa2116596 |
| PubMed: | View item in PubMed |
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