PMID- 37890149
OWN - NLM
STAT- MEDLINE
DCOM- 20240202
LR  - 20240324
IS  - 1528-0020 (Electronic)
IS  - 0006-4971 (Linking)
VI  - 143
IP  - 5
DP  - 2024 Feb 1
TI  - Two-year follow-up of lisocabtagene maraleucel in relapsed or refractory large 
      B-cell lymphoma in TRANSCEND NHL 001.
PG  - 404-416
LID - 10.1182/blood.2023020854 [doi]
AB  - Lisocabtagene maraleucel (liso-cel) demonstrated significant efficacy with a 
      manageable safety profile as third-line or later treatment for patients with 
      relapsed or refractory (R/R) large B-cell lymphoma (LBCL) in the TRANSCEND NHL 
      001 study. Primary end points were adverse events (AEs), dose-limiting 
      toxicities, and objective response rate (ORR) per independent review committee. 
      Key secondary end points were complete response (CR) rate, duration of response 
      (DOR), progression-free survival (PFS), and overall survival (OS). After 2-year 
      follow-up, patients could enroll in a separate study assessing long-term (</=15 
      years) safety and OS. Liso-cel-treated patients (N = 270) had a median age of 63 
      years (range, 18-86 years) and a median of 3 prior lines (range, 1-8) of systemic 
      therapy, and 181 of them (67%) had chemotherapy-refractory LBCL. Median follow-up 
      was 19.9 months. In efficacy-evaluable patients (N = 257), the ORR was 73% and CR 
      rate was 53%. The median (95% confidence interval) DOR, PFS, and OS were 23.1 
      (8.6 to not reached), 6.8 (3.3-12.7), and 27.3 months (16.2-45.6), respectively. 
      Estimated 2-year DOR, PFS, and OS rates were 49.5%, 40.6%, and 50.5%, 
      respectively. In the 90-day treatment-emergent period (N = 270), grade 3 to 4 
      cytokine release syndrome and neurological events occurred in 2% and 10% of 
      patients, respectively. The most common grade >/=3 AEs in treatment-emergent and 
      posttreatment-emergent periods, respectively, were neutropenia (60% and 7%) and 
      anemia (37% and 6%). Liso-cel demonstrated durable remissions and a manageable 
      safety profile with no new safety signals during the 2-year follow-up in patients 
      with R/R LBCL. These trials were registered at www.ClinicalTrials.gov as 
      #NCT02631044 and #NCT03435796.
CI  - (c) 2024 American Society of Hematology. Published by Elsevier Inc. All rights are 
      reserved, including those for text and data mining, AI training, and similar 
      technologies.
FAU - Abramson, Jeremy S
AU  - Abramson JS
AUID- ORCID: 0000-0001-8467-9257
AD  - Lymphoma Program, Massachusetts General Hospital Cancer Center, Harvard Medical 
      School, Boston, MA.
FAU - Palomba, M Lia
AU  - Palomba ML
AD  - Memorial Sloan Kettering Cancer Center, New York, NY.
FAU - Gordon, Leo I
AU  - Gordon LI
AUID- ORCID: 0000-0003-1666-7064
AD  - Department of Hematology/Oncology, Northwestern University, Feinberg School of 
      Medicine, Robert H. Lurie Comprehensive Cancer Center, Chicago, IL.
FAU - Lunning, Matthew
AU  - Lunning M
AD  - Hematology/Oncology Division, University of Nebraska Medical Center, Omaha, NE.
FAU - Wang, Michael
AU  - Wang M
AUID- ORCID: 0000-0001-9748-5486
AD  - Department of Lymphoma/Myeloma, University of Texas MD Anderson Cancer Center, 
      Houston, TX.
FAU - Arnason, Jon
AU  - Arnason J
AD  - Department of Hematology/Oncology, Beth Israel Deaconess Medical Center, Boston, 
      MA.
FAU - Purev, Enkhtsetseg
AU  - Purev E
AD  - University of Colorado School of Medicine, Aurora, CO.
FAU - Maloney, David G
AU  - Maloney DG
AD  - Clinical Research Division Medicine and Oncology, Fred Hutchinson Cancer Research 
      Center, Seattle, WA.
FAU - Andreadis, Charalambos
AU  - Andreadis C
AD  - University of California San Francisco, San Francisco, CA.
FAU - Sehgal, Alison
AU  - Sehgal A
AD  - University of Pittsburgh Medical Center: Hillman Cancer Center, Pittsburgh, PA.
FAU - Solomon, Scott R
AU  - Solomon SR
AD  - Transplant and Cellular Immunotherapy Program, Northside Hospital Cancer 
      Institute, Atlanta, GA.
FAU - Ghosh, Nilanjan
AU  - Ghosh N
AD  - Department of Hematologic Oncology and Blood Disorders, Atrium Health, Levine 
      Cancer Institute, Charlotte, NC.
FAU - Dehner, Christine
AU  - Dehner C
AD  - Bristol Myers Squibb, Seattle, WA.
FAU - Kim, Yeonhee
AU  - Kim Y
AD  - Bristol Myers Squibb, Seattle, WA.
FAU - Ogasawara, Ken
AU  - Ogasawara K
AUID- ORCID: 0000-0002-4264-8927
AD  - Bristol Myers Squibb, Princeton, NJ.
FAU - Kostic, Ana
AU  - Kostic A
AD  - Bristol Myers Squibb, Seattle, WA.
FAU - Siddiqi, Tanya
AU  - Siddiqi T
AUID- ORCID: 0000-0001-5292-8298
AD  - Department of Hematology and Hematopoietic Cell Transplantation, City of Hope 
      National Medical Center, Duarte, CA.
LA  - eng
SI  - ClinicalTrials.gov/NCT03435796
SI  - ClinicalTrials.gov/NCT02631044
PT  - Journal Article
PL  - United States
TA  - Blood
JT  - Blood
JID - 7603509
SB  - IM
CIN - Blood. 2024 Feb 1;143(5):379-380. PMID: 38300610
MH  - Humans
MH  - Adolescent
MH  - Young Adult
MH  - Adult
MH  - Middle Aged
MH  - Aged
MH  - Aged, 80 and over
MH  - Follow-Up Studies
MH  - Neoplasm Recurrence, Local/etiology
MH  - *Lymphoma, Large B-Cell, Diffuse/therapy
MH  - *Neutropenia/etiology
MH  - Immunotherapy, Adoptive/adverse effects
EDAT- 2023/10/27 18:42
MHDA- 2024/02/02 06:43
CRDT- 2023/10/27 16:23
PHST- 2023/09/21 00:00 [accepted]
PHST- 2023/04/24 00:00 [received]
PHST- 2024/02/02 06:43 [medline]
PHST- 2023/10/27 18:42 [pubmed]
PHST- 2023/10/27 16:23 [entrez]
AID - S0006-4971(23)14157-7 [pii]
AID - 10.1182/blood.2023020854 [doi]
PST - ppublish
SO  - Blood. 2024 Feb 1;143(5):404-416. doi: 10.1182/blood.2023020854.