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

Hoa Van Le, Kim Van Naarden Braun, Grzegorz S. Nowakowski, David Sermer, John Radford, William Townsend, Herve Ghesquieres, Tobias Menne, Edit Porpaczy, Christopher P. Fox, Claudia Schusterbauer, Fei Fei Liu, Lihua Yue, Marc De Benedetti, Jens Hasskarl

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
Pages (from-to)573-585
Number of pages13
JournalLeukemia and Lymphoma
Volume64
Issue number3
DOIs
StatePublished - 2023

Keywords

  • CAR T-cell therapy
  • large B-cell lymphoma
  • real-world data
  • synthetic control

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

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