Use of a real-world synthetic control arm for direct comparison of lisocabtagene maraleucel and conventional therapy in relapsed/refractory large B-cell lymphoma
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Authors
Van Le, H.Van Naarden Braun, K.
Nowakowski, G. S.
Sermer, D.
Radford, John A
Townsend, W.
Ghesquieres, H.
Menne, T.
Porpaczy, E.
Fox, C. P.
Schusterbauer, C.
Liu, F. F.
Yue, L.
De Benedetti, M.
Hasskarl, J.
Affiliation
Biometrics and Data Sciences, Bristol Myers Squibb, Princeton, NJ, USAIssue Date
2023
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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.Citation
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.Journal
Leukemia & LymphomaDOI
10.1080/10428194.2022.2160200PubMed ID
36755418Additional Links
https://dx.doi.org/10.1080/10428194.2022.2160200Type
ArticleLanguage
enae974a485f413a2113503eed53cd6c53
10.1080/10428194.2022.2160200