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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
Van Le, H. Van Naarden Braun, K. Nowakowski, G. S. Sermer, D. Townsend, W. Ghesquieres, H. Menne, T. Porpaczy, E. Fox, C. P.
Van Le, H.
Van Naarden Braun, K.
Nowakowski, G. S.
Sermer, D.
Townsend, W.
Ghesquieres, H.
Menne, T.
Porpaczy, E.
Fox, C. P.
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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.
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Date
2023
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Van Le H, Van Naarden Braun K, Nowakowski GS, Sermer D, Radford J, Townsend W, et al. Use of a real-world synthetic control arm for direct comparison of lisocabtagene maraleucel and conventional therapy in relapsed/refractory large B-cell lymphoma. Leuk Lymphoma. 2023 Feb 8:1-13. PubMed PMID: 36755418. Epub 2023/02/10. eng.