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Use of a real-world synthetic control arm for direct comparison of lisocabtagene maraleucel and conventional therapy in relapsed/refractory large B-cell lymphoma

Lookup NU author(s): Dr Tobias Menne



This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (CC BY-NC-ND).


© 2023 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.This study used a real-world population as a synthetic comparator for the single-arm TRANSCEND NHL 001 study (TRANSCEND; NCT02631044) to evaluate the efficacy of lisocabtagene maraleucel (liso-cel) compared with conventional (noncellular) therapies in patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL). Inclusion and exclusion criteria for the real-world study closely matched the enrollment criteria in TRANSCEND. The analytic comparator cohort was created by matching and balancing observed baseline characteristics of real-world patients with those in TRANSCEND using propensity score methodology. Efficacy outcomes comparing liso-cel– (n = 257) and conventional therapy–treated (n = 257) patients, respectively, significantly favored liso-cel: overall response rate (74% vs 39%; p < 0.0001), complete response rate (50% vs 24%; p < 0.0001), median overall survival (23.5 vs 6.8 months; p < 0.0001), and median progression-free survival (3.5 vs 2.2 months; p < 0.0001). These results demonstrated a statistically significant and clinically meaningful benefit of liso-cel in patients with third- or later-line R/R LBCL relative to conventional therapies. Clinical trial registration: identifier: NCT02631044.

Publication metadata

Author(s): Van Le H, Van Naarden Braun K, Nowakowski GS, Sermer D, Radford J, Townsend W, Ghesquieres H, Menne T, Porpaczy E, Fox CP, Schusterbauer C, Liu FF, Yue L, De Benedetti M, Hasskarl J

Publication type: Article

Publication status: Published

Journal: Leukemia and Lymphoma

Year: 2023

Volume: 64

Issue: 3

Pages: 573-585

Online publication date: 08/02/2023

Acceptance date: 08/12/2022

Date deposited: 23/02/2023

ISSN (print): 1042-8194

ISSN (electronic): 1029-2403

Publisher: Taylor and Francis Ltd.


DOI: 10.1080/10428194.2022.2160200

PubMed id: 36755418


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Funder referenceFunder name
Bristol Myers Squibb