PMID- 35156195
OWN - NLM
STAT- MEDLINE
DCOM- 20220621
LR  - 20220912
IS  - 1532-6535 (Electronic)
IS  - 0009-9236 (Print)
IS  - 0009-9236 (Linking)
VI  - 112
IP  - 1
DP  - 2022 Jul
TI  - In Vivo Cellular Expansion of Lisocabtagene Maraleucel and Association With 
      Efficacy and Safety in Relapsed/Refractory Large B-Cell Lymphoma.
PG  - 81-89
LID - 10.1002/cpt.2561 [doi]
AB  - Lisocabtagene maraleucel (liso-cel) is an autologous, CD19-directed, chimeric 
      antigen receptor T-cell product for the treatment of adult patients with relapsed 
      or refractory large B-cell lymphoma (LBCL) after 2 or more lines of systemic 
      therapy. In vivo cellular expansion after single-dose administration of liso-cel 
      has been characterized. In this article, in vivo liso-cel expansion in the 
      pivotal study TRANSCEND NHL 001 (ClinicalTrials.gov identifier, NCT02631044) was 
      further characterized to assess the relationship between in vivo cellular 
      expansion after single-dose administration of liso-cel and efficacy or safety 
      after adjusting for key baseline characteristics. Two bioanalytical methods, 
      quantitative polymerase chain reaction and flow cytometry, were used for the 
      assessment of cellular kinetics of liso-cel, which showed high concordance for in 
      vivo cellular expansion. Multivariable logistic regression analyses demonstrated 
      that higher in vivo cellular expansion of liso-cel was associated with a higher 
      overall response and complete response rate, and a higher incidence of cytokine 
      release syndrome and neurological events in patients with relapsed or refractory 
      LBCL. Age and tumor burden (by sum of the product of perpendicular diameters) 
      were likely to confound the relationship between in vivo cellular expansion and 
      efficacy, where the association became stronger after controlling for these 
      factors. Repeat dosing of liso-cel was tested in the study; however, in vivo 
      cellular expansion of liso-cel was lower after repeat dosing than after the 
      initial dose. These findings should enable a comprehensive understanding of the 
      in vivo cellular kinetics of liso-cel and the association with outcomes in 
      relapsed/refractory LBCL.
CI  - (c) 2022 Bristol Myers Squibb. Clinical Pharmacology & Therapeutics published by 
      Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and 
      Therapeutics.
FAU - Ogasawara, Ken
AU  - Ogasawara K
AUID- ORCID: 0000-0002-4264-8927
AD  - Bristol Myers Squibb, Princeton, New Jersey, USA.
FAU - Lymp, James
AU  - Lymp J
AD  - Bristol Myers Squibb, Seattle, Washington, USA.
FAU - Mack, Timothy
AU  - Mack T
AD  - Bristol Myers Squibb, Princeton, New Jersey, USA.
FAU - Dell'Aringa, Justine
AU  - Dell'Aringa J
AD  - Bristol Myers Squibb, Seattle, Washington, USA.
FAU - Huang, Chang-Pin
AU  - Huang CP
AD  - Bristol Myers Squibb, Seattle, Washington, USA.
FAU - Smith, Jeff
AU  - Smith J
AD  - Bristol Myers Squibb, Seattle, Washington, USA.
FAU - Peiser, Leanne
AU  - Peiser L
AD  - Bristol Myers Squibb, Seattle, Washington, USA.
FAU - Kostic, Ana
AU  - Kostic A
AD  - Bristol Myers Squibb, Seattle, Washington, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT02631044
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20220320
PL  - United States
TA  - Clin Pharmacol Ther
JT  - Clinical pharmacology and therapeutics
JID - 0372741
RN  - 0 (Antigens, CD19)
RN  - 0 (Receptors, Chimeric Antigen)
SB  - IM
CIN - Clin Pharmacol Ther. 2022 Jul;112(1):11-15. PMID: 35716389
MH  - Adult
MH  - Antigens, CD19
MH  - Humans
MH  - Immunotherapy, Adoptive/adverse effects/methods
MH  - *Lymphoma, Large B-Cell, Diffuse/drug therapy
MH  - *Receptors, Chimeric Antigen
MH  - T-Lymphocytes
PMC - PMC9311712
COIS- K.O., J.L., T.M., J.D., C.H., J.S., L.P., and A.K. are employees of Bristol Myers 
      Squibb and hold stock in Bristol Myers Squibb.
EDAT- 2022/02/15 06:00
MHDA- 2022/06/22 06:00
PMCR- 2022/03/20
CRDT- 2022/02/14 05:38
PHST- 2021/11/02 00:00 [received]
PHST- 2022/02/07 00:00 [accepted]
PHST- 2022/02/15 06:00 [pubmed]
PHST- 2022/06/22 06:00 [medline]
PHST- 2022/02/14 05:38 [entrez]
PHST- 2022/03/20 00:00 [pmc-release]
AID - CPT2561 [pii]
AID - 10.1002/cpt.2561 [doi]
PST - ppublish
SO  - Clin Pharmacol Ther. 2022 Jul;112(1):81-89. doi: 10.1002/cpt.2561. Epub 2022 Mar 
      20.