PMID- 36755418
OWN - NLM
STAT- MEDLINE
DCOM- 20230329
LR  - 20230413
IS  - 1029-2403 (Electronic)
IS  - 1026-8022 (Linking)
VI  - 64
IP  - 3
DP  - 2023 Mar
TI  - Use of a real-world synthetic control arm for direct comparison of lisocabtagene 
      maraleucel and conventional therapy in relapsed/refractory large B-cell lymphoma.
PG  - 573-585
LID - 10.1080/10428194.2022.2160200 [doi]
AB  - 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.
FAU - Van Le, Hoa
AU  - Van Le H
AD  - Biometrics and Data Sciences, Bristol Myers Squibb, Princeton, NJ, USA.
FAU - Van Naarden Braun, Kim
AU  - Van Naarden Braun K
AD  - Translational Epidemiology, Bristol Myers Squibb, Princeton, NJ, USA.
FAU - Nowakowski, Grzegorz S
AU  - Nowakowski GS
AD  - Hematology, Mayo Clinic, Rochester, MN, USA.
FAU - Sermer, David
AU  - Sermer D
AUID- ORCID: 0000-0003-0528-7728
AD  - Lymphoma Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, 
      New York, NY, USA.
FAU - Radford, John
AU  - Radford J
AD  - Department of Medical Oncology, The Christie NHS Foundation Trust and University 
      of Manchester, Manchester Academic Health Science Centre, Manchester, UK.
FAU - Townsend, William
AU  - Townsend W
AD  - Hematology, University College London Hospitals NHS Foundation Trust, London, UK.
FAU - Ghesquieres, Herve
AU  - Ghesquieres H
AUID- ORCID: 0000-0002-3131-3718
AD  - Department of Hematology, Hopital Lyon Sud, Lyon, France.
FAU - Menne, Tobias
AU  - Menne T
AD  - Hematology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Northumberland, 
      UK.
FAU - Porpaczy, Edit
AU  - Porpaczy E
AD  - Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.
FAU - Fox, Christopher P
AU  - Fox CP
AD  - Department of Clinical Hematology, Nottingham University Hospitals NHS Trust, 
      Nottingham, UK.
FAU - Schusterbauer, Claudia
AU  - Schusterbauer C
AD  - Clinical Research and Development, Celgene, a Bristol-Myers Squibb Company, 
      Boudry, Switzerland.
FAU - Liu, Fei Fei
AU  - Liu FF
AD  - Worldwide Health Economics and Outcomes Research CAR T, Bristol Myers Squibb, 
      Princeton, NJ, USA.
FAU - Yue, Lihua
AU  - Yue L
AD  - Statistics, Bristol Myers Squibb, Princeton, NJ, USA.
FAU - De Benedetti, Marc
AU  - De Benedetti M
AD  - Biometrics and Data Sciences, Bristol Myers Squibb, Princeton, NJ, USA.
FAU - Hasskarl, Jens
AU  - Hasskarl J
AD  - Cell Therapy Development, Celgene, a Bristol-Myers Squibb Company, Boudry, 
      Switzerland.
LA  - eng
SI  - ClinicalTrials.gov/NCT02631044
PT  - Clinical Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20230208
PL  - United States
TA  - Leuk Lymphoma
JT  - Leukemia & lymphoma
JID - 9007422
RN  - 0 (Antigens, CD19)
SB  - IM
MH  - Humans
MH  - Antigens, CD19
MH  - Immunotherapy, Adoptive/adverse effects
MH  - *Lymphoma, Large B-Cell, Diffuse/drug therapy
MH  - Progression-Free Survival
MH  - Propensity Score
OTO - NOTNLM
OT  - CAR T-cell therapy
OT  - large B-cell lymphoma
OT  - real-world data
OT  - synthetic control
EDAT- 2023/02/10 06:00
MHDA- 2023/03/24 06:00
CRDT- 2023/02/09 00:43
PHST- 2023/02/10 06:00 [pubmed]
PHST- 2023/03/24 06:00 [medline]
PHST- 2023/02/09 00:43 [entrez]
AID - 10.1080/10428194.2022.2160200 [doi]
PST - ppublish
SO  - Leuk Lymphoma. 2023 Mar;64(3):573-585. doi: 10.1080/10428194.2022.2160200. Epub 
      2023 Feb 8.