PMID- 35619325
OWN - NLM
STAT- MEDLINE
DCOM- 20221221
LR  - 20230201
IS  - 2045-7634 (Electronic)
IS  - 2045-7634 (Linking)
VI  - 11
IP  - 24
DP  - 2022 Dec
TI  - Phase 2 results of lisocabtagene maraleucel in Japanese patients with 
      relapsed/refractory aggressive B-cell non-Hodgkin lymphoma.
PG  - 4889-4899
LID - 10.1002/cam4.4820 [doi]
AB  - The autologous anti-CD19 chimeric antigen receptor (CAR) T-cell product, 
      lisocabtagene maraleucel (liso-cel), is administered at equal target doses of 
      CD8(+) and CD4(+) CAR(+) T cells. This analysis assessed safety and efficacy of 
      liso-cel in Japanese patients with relapsed or refractory (R/R) aggressive large 
      B-cell lymphoma (LBCL) in Cohort 3 of TRANSCEND WORLD (NCT03484702). Liso-cel 
      (100 x 10(6) total CAR(+) T cells) was administered 2-7 days after 
      lymphodepletion. The primary efficacy endpoint was objective response rate (ORR; 
      Lugano 2014 criteria) assessed by an independent review committee. Fourteen 
      patients were enrolled; 10 received liso-cel infusion (median time to liso-cel 
      availability, 23 days) and were evaluable at data cutoff (median follow-up, 
      12.5 months). Grade >/= 3 treatment-emergent adverse events were neutropenia (90%), 
      leukopenia (80%), anemia (70%), and thrombocytopenia (70%). All-grade cytokine 
      release syndrome (CRS) was observed in 50% of patients, though no grade >/=3 CRS 
      events were reported. Grade 1 neurological events occurred in 1 patient but were 
      resolved without any intervention. Prolonged cytopenia (grade >/= 3 at day 29) was 
      reported for 60% of patients. The ORR was 70%, and complete response rate was 
      50%. The median duration of response was 9.1 months (95% confidence interval 
      [CI], 2.1-not reached), and overall survival was 14.7 months (95% CI, 1.7-not 
      reached). One patient diagnosed with central nervous system involvement after 
      screening but before liso-cel infusion, responded to liso-cel. Liso-cel 
      demonstrated meaningful efficacy and a manageable safety profile in Japanese 
      patients with R/R LBCL.
CI  - (c) 2022 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.
FAU - Makita, Shinichi
AU  - Makita S
AUID- ORCID: 0000-0001-6609-8088
AD  - National Cancer Center Hospital, Tokyo, Japan.
FAU - Yamamoto, Go
AU  - Yamamoto G
AD  - Toranomon Hospital, Tokyo, Japan.
FAU - Maruyama, Dai
AU  - Maruyama D
AD  - National Cancer Center Hospital, Tokyo, Japan.
FAU - Asano-Mori, Yuki
AU  - Asano-Mori Y
AD  - Toranomon Hospital, Tokyo, Japan.
FAU - Kaji, Daisuke
AU  - Kaji D
AD  - Toranomon Hospital, Tokyo, Japan.
FAU - Ananthakrishnan, Revathi
AU  - Ananthakrishnan R
AD  - Bristol Myers Squibb, Princeton, New Jersey, USA.
FAU - Ogasawara, Ken
AU  - Ogasawara K
AUID- ORCID: 0000-0002-4264-8927
AD  - Bristol Myers Squibb, Princeton, New Jersey, USA.
FAU - Stepan, Lara
AU  - Stepan L
AD  - Bristol Myers Squibb, Princeton, New Jersey, USA.
FAU - Schusterbauer, Claudia
AU  - Schusterbauer C
AD  - Celgene, a Bristol-Myers Squibb Company, Boudry, Switzerland.
FAU - Rettby, Nils
AU  - Rettby N
AD  - Celgene, a Bristol-Myers Squibb Company, Boudry, Switzerland.
FAU - Hasskarl, Jens
AU  - Hasskarl J
AD  - Celgene, a Bristol-Myers Squibb Company, Boudry, Switzerland.
FAU - Izutsu, Koji
AU  - Izutsu K
AUID- ORCID: 0000-0001-9129-8057
AD  - National Cancer Center Hospital, Tokyo, Japan.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20220526
PL  - United States
TA  - Cancer Med
JT  - Cancer medicine
JID - 101595310
RN  - 0 (Antigens, CD19)
RN  - 0 (Receptors, Chimeric Antigen)
SB  - IM
MH  - Humans
MH  - Antigens, CD19
MH  - Cytokine Release Syndrome/chemically induced/epidemiology
MH  - *Immunotherapy, Adoptive/adverse effects
MH  - *Lymphoma, Large B-Cell, Diffuse/drug therapy
MH  - Receptors, Chimeric Antigen
MH  - Thrombocytopenia/chemically induced/epidemiology
MH  - Japan
PMC - PMC9761090
OTO - NOTNLM
OT  - Japanese patients
OT  - large B-cell lymphoma
OT  - lisocabtagene maraleucel
OT  - non-Hodgkin lymphoma
OT  - relapsed/refractory
COIS- Shinichi Makita has received honoraria from Celgene, a Bristol-Myers Squibb 
      Company, Chugai, Daiichi Sankyo, Eisai, Novartis, and Takeda. Go Yamamoto, Dai 
      Maruyama, Yuki Asano-Mori, and Daisuke Kaji have no conflicts to report. Revathi 
      Ananthakrishnan, Ken Ogasawara, and Lara Stepan are employees of Bristol Myers 
      Squibb and may own stock in Bristol Myers Squibb. Jens Hasskarl was an employee 
      of Celgene, a Bristol-Myers Squibb Company, at the time of this analysis and may 
      own stock in Bristol Myers Squibb. Nils Rettby and Claudia Schusterbauer are 
      employees of Celgene, a Bristol-Myers Squibb Company, and may own stock in 
      Bristol Myers Squibb. Koji Izutsu has received research funding from Celgene, a 
      Bristol-Myers Squibb Company.
EDAT- 2022/05/28 06:00
MHDA- 2022/12/21 06:00
PMCR- 2022/05/26
CRDT- 2022/05/27 01:14
PHST- 2022/02/08 00:00 [revised]
PHST- 2021/11/01 00:00 [received]
PHST- 2022/02/20 00:00 [accepted]
PHST- 2022/05/28 06:00 [pubmed]
PHST- 2022/12/21 06:00 [medline]
PHST- 2022/05/27 01:14 [entrez]
PHST- 2022/05/26 00:00 [pmc-release]
AID - CAM44820 [pii]
AID - 10.1002/cam4.4820 [doi]
PST - ppublish
SO  - Cancer Med. 2022 Dec;11(24):4889-4899. doi: 10.1002/cam4.4820. Epub 2022 May 26.