Universität zu Köln

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., Mueller, 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., Jaeger, U., Borchmann, P. and Westin, J. R. (2022). Second-Line Tisagenlecleucel or Standard Care in Aggressive B-Cell Lymphoma. N. Engl. J. Med., 386 (7). S. 629 - 640. WALTHAM: MASSACHUSETTS MEDICAL SOC. ISSN 1533-4406

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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.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Bishop, M. R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Dickinson, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Purtill, D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Barba, P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Santoro, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hamad, N. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kato, K. UNSPECIFIED UNSPECIFIED UNSPECIFIED Sureda, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Greil, R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Thieblemont, C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Morschhauser, F. UNSPECIFIED UNSPECIFIED UNSPECIFIED Janz, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Flinn, I UNSPECIFIED UNSPECIFIED UNSPECIFIED Rabitsch, W. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kwong, Y-L UNSPECIFIED UNSPECIFIED UNSPECIFIED Kersten, M. J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Minnema, M. C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Holte, H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Chan, E. H. L. UNSPECIFIED UNSPECIFIED UNSPECIFIED Martinez-Lopez, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Mueller, A. M. S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Maziarz, R. T. UNSPECIFIED UNSPECIFIED UNSPECIFIED McGuirk, J. P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Bachy, E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Le Gouill, S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Dreyling, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Harigae, H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Bond, D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Andreadis, C. UNSPECIFIED UNSPECIFIED UNSPECIFIED McSweeney, P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kharfan-Dabaja, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Newsome, S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Degtyarev, E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Awasthi, R. UNSPECIFIED UNSPECIFIED UNSPECIFIED del Corral, C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Andreola, G. UNSPECIFIED UNSPECIFIED UNSPECIFIED Masood, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Schuster, S. J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Jaeger, U. UNSPECIFIED UNSPECIFIED UNSPECIFIED Borchmann, P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Westin, J. R. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-608029
DOI:	10.1056/NEJMoa2116596
Journal or Publication Title:	N. Engl. J. Med.
Volume:	386
Number:	7
Page Range:	S. 629 - 640
Date:	2022
Publisher:	MASSACHUSETTS MEDICAL SOC
Place of Publication:	WALTHAM
ISSN:	1533-4406
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language AXICABTAGENE CILOLEUCEL; OUTCOMES Multiple languages Medicine, General & Internal Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/60802