PMID- 38072625
OWN - NLM
STAT- MEDLINE
DCOM- 20240329
LR  - 20240331
IS  - 1527-7755 (Electronic)
IS  - 0732-183X (Linking)
VI  - 42
IP  - 10
DP  - 2024 Apr 1
TI  - Lisocabtagene Maraleucel in Relapsed/Refractory Mantle Cell Lymphoma: Primary 
      Analysis of the Mantle Cell Lymphoma Cohort From TRANSCEND NHL 001, a Phase I 
      Multicenter Seamless Design Study.
PG  - 1146-1157
LID - 10.1200/JCO.23.02214 [doi]
AB  - PURPOSE: To report the primary analysis results from the mantle cell lymphoma 
      (MCL) cohort of the phase I seamless design TRANSCEND NHL 001 (ClinicalTrials.gov 
      identifier: NCT02631044) study. METHODS: Patients with relapsed/refractory (R/R) 
      MCL after >/=two lines of previous therapy, including a Bruton tyrosine kinase 
      inhibitor (BTKi), an alkylating agent, and a CD20-targeted agent, received 
      lisocabtagene maraleucel (liso-cel) at a target dose level (DL) of 50 x 10(6) 
      (DL1) or 100 x 10(6) (DL2) chimeric antigen receptor-positive T cells. Primary 
      end points were adverse events (AEs), dose-limiting toxicities, and objective 
      response rate (ORR) by independent review committee per Lugano criteria. RESULTS: 
      Of 104 leukapheresed patients, liso-cel was infused into 88. Median (range) 
      number of previous lines of therapy was three (1-11) with 30% receiving >/=five 
      previous lines of therapy, 73% of patients were age 65 years and older, 69% had 
      refractory disease, 53% had BTKi refractory disease, 23% had TP53 mutation, and 
      8% had secondary CNS lymphoma. Median (range) on-study follow-up was 16.1 months 
      (0.4-60.5). In the efficacy set (n = 83; DL1 + DL2), ORR was 83.1% (95% CI, 73.3 
      to 90.5) and complete response (CR) rate was 72.3% (95% CI, 61.4 to 81.6). Median 
      duration of response was 15.7 months (95% CI, 6.2 to 24.0) and progression-free 
      survival was 15.3 months (95% CI, 6.6 to 24.9). Most common grade >/=3 
      treatment-emergent AEs were neutropenia (56%), anemia (37.5%), and 
      thrombocytopenia (25%). Cytokine release syndrome (CRS) was reported in 61% of 
      patients (grade 3/4, 1%; grade 5, 0), neurologic events (NEs) in 31% (grade 3/4, 
      9%; grade 5, 0), grade >/=3 infections in 15%, and prolonged cytopenia in 40%. 
      CONCLUSION: Liso-cel demonstrated high CR rate and deep, durable responses with 
      low incidence of grade >/=3 CRS, NE, and infections in patients with heavily 
      pretreated R/R MCL, including those with high-risk, aggressive disease.
FAU - Wang, Michael
AU  - Wang M
AUID- ORCID: 0000-0001-9748-5486
AD  - The University of Texas MD Anderson Cancer Center, Houston, TX.
FAU - Siddiqi, Tanya
AU  - Siddiqi T
AUID- ORCID: 0000-0001-5292-8298
AD  - City of Hope National Medical Center, Duarte, CA.
FAU - Gordon, Leo I
AU  - Gordon LI
AUID- ORCID: 0000-0003-1666-7064
AD  - Northwestern University, Feinberg School of Medicine, Robert H. Lurie 
      Comprehensive Cancer Center, Chicago, IL.
FAU - Kamdar, Manali
AU  - Kamdar M
AD  - University of Colorado Cancer Center, Aurora, CO.
FAU - Lunning, Matthew
AU  - Lunning M
AD  - University of Nebraska Medical Center, Omaha, NE.
FAU - Hirayama, Alexandre V
AU  - Hirayama AV
AUID- ORCID: 0000-0001-7980-3882
AD  - Fred Hutchinson Cancer Center, Seattle, WA.
FAU - Abramson, Jeremy S
AU  - Abramson JS
AUID- ORCID: 0000-0001-8467-9257
AD  - Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA.
FAU - Arnason, Jon
AU  - Arnason J
AD  - Beth Israel Deaconess Medical Center, Boston, MA.
FAU - Ghosh, Nilanjan
AU  - Ghosh N
AD  - Atrium Health, Levine Cancer Institute, Charlotte, NC.
FAU - Mehta, Amitkumar
AU  - Mehta A
AD  - University of Alabama at Birmingham, Birmingham, AL.
FAU - Andreadis, Charalambos
AU  - Andreadis C
AD  - University of California, San Francisco, San Francisco, CA.
FAU - Solomon, Scott R
AU  - Solomon SR
AUID- ORCID: 0000-0003-2061-8126
AD  - Northside Hospital Cancer Institute, Atlanta, GA.
FAU - Kostic, Ana
AU  - Kostic A
AD  - Bristol Myers Squibb, Seattle, WA.
FAU - Dehner, Christine
AU  - Dehner C
AD  - Bristol Myers Squibb, Seattle, WA.
FAU - Espinola, Ricardo
AU  - Espinola R
AD  - Bristol Myers Squibb, San Diego, CA.
FAU - Peng, Lily
AU  - Peng L
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 - Chattin, Amy
AU  - Chattin A
AUID- ORCID: 0009-0000-1099-1678
AD  - Bristol Myers Squibb, Seattle, WA.
FAU - Eliason, Laurie
AU  - Eliason L
AD  - Bristol Myers Squibb, Princeton, NJ.
FAU - Palomba, M Lia
AU  - Palomba ML
AUID- ORCID: 0000-0001-5099-9156
AD  - Memorial Sloan Kettering Cancer Center, New York, NY.
LA  - eng
SI  - ClinicalTrials.gov/NCT02631044
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Multicenter Study
DEP - 20231210
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
RN  - 0 (Antineoplastic Agents)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Humans
MH  - *Antineoplastic Agents/adverse effects
MH  - Immunotherapy, Adoptive/adverse effects
MH  - *Lymphoma, Large B-Cell, Diffuse/drug therapy
MH  - *Lymphoma, Mantle-Cell
MH  - Neoplasm Recurrence, Local/drug therapy
MH  - *Neutropenia/chemically induced
EDAT- 2023/12/11 00:42
MHDA- 2024/03/29 06:46
CRDT- 2023/12/10 21:13
PHST- 2024/03/29 06:46 [medline]
PHST- 2023/12/11 00:42 [pubmed]
PHST- 2023/12/10 21:13 [entrez]
AID - 10.1200/JCO.23.02214 [doi]
PST - ppublish
SO  - J Clin Oncol. 2024 Apr 1;42(10):1146-1157. doi: 10.1200/JCO.23.02214. Epub 2023 
      Dec 10.