Use of a real-world synthetic control arm for direct comparison of lisocabtagene maraleucel and conventional therapy in relapsed/refractory large B-cell lymphoma. Issue 3 (23rd February 2023)

• Record Type: Journal Article
• Authors: Van Le, Hoa; Van Naarden Braun, Kim; Nowakowski, Grzegorz S.; Sermer, David; Radford, John; Townsend, William; Ghesquieres, Herve; Menne, Tobias; Porpaczy, Edit; Fox, Christopher P.; Schusterbauer, Claudia; Liu, Fei Fei; Yue, Lihua; De Benedetti, Marc; Hasskarl, Jens
• Is Part Of: Leukemia & lymphoma. Volume 64:Issue 3(2023)
• Page Start: 573
• Page End: 585
• Publication Date: 2023-02-23
• Subjects: CAR T-cell therapy -- large B-cell lymphoma -- real-world data -- synthetic control; Leukemia -- Periodicals; Lymphomas -- Periodicals; 616.99419
• DOI: 10.1080/10428194.2022.2160200
• Languages: English
• ISSNs: 1042-8194

Abstract

Abstract: 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: ClinicalTrials.gov identifier: NCT02631044