Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphomas (TRANSCEND NHL 001): a multicentre seamless design study.
Aged
Aged, 80 and over
Anemia
/ epidemiology
Antigens, CD19
/ administration & dosage
Biological Products
CD4-Positive T-Lymphocytes
/ immunology
CD8-Positive T-Lymphocytes
/ immunology
Cytokine Release Syndrome
/ epidemiology
Female
Humans
Immunotherapy, Adoptive
/ adverse effects
Infusions, Intravenous
Leukapheresis
/ methods
Lymphoma, Large B-Cell, Diffuse
/ classification
Male
Nervous System Diseases
/ epidemiology
Neutropenia
/ epidemiology
Recurrence
Safety
Survival Analysis
Thrombocytopenia
/ epidemiology
Treatment Outcome
Journal
Lancet (London, England)
ISSN: 1474-547X
Titre abrégé: Lancet
Pays: England
ID NLM: 2985213R
Informations de publication
Date de publication:
19 09 2020
19 09 2020
Historique:
received:
06
05
2020
revised:
22
05
2020
accepted:
09
06
2020
pubmed:
6
9
2020
medline:
21
10
2020
entrez:
5
9
2020
Statut:
ppublish
Résumé
Lisocabtagene maraleucel (liso-cel) is an autologous, CD19-directed, chimeric antigen receptor (CAR) T-cell product. We aimed to assess the activity and safety of liso-cel in patients with relapsed or refractory large B-cell lymphomas. We did a seamless design study at 14 cancer centres in the USA. We enrolled adult patients (aged ≥18 years) with relapsed or refractory large B-cell lymphomas. Eligible histological subgroups included diffuse large B-cell lymphoma, high-grade B-cell lymphoma with rearrangements of MYC and either BCL2, BCL6, or both (double-hit or triple-hit lymphoma), diffuse large B-cell lymphoma transformed from any indolent lymphoma, primary mediastinal B-cell lymphoma, and follicular lymphoma grade 3B. Patients were assigned to one of three target dose levels of liso-cel as they were sequentially tested in the trial (50 × 10 Between Jan 11, 2016, and July 5, 2019, 344 patients underwent leukapheresis for manufacture of CAR Use of liso-cel resulted in a high objective response rate, with a low incidence of grade 3 or worse cytokine release syndrome and neurological events in patients with relapsed or refractory large B-cell lymphomas, including those with diverse histological subtypes and high-risk features. Liso-cel is under further evaluation at first relapse in large B-cell lymphomas and as a treatment for other relapsed or refractory B-cell malignancies. Juno Therapeutics, a Bristol-Myers Squibb Company.
Sections du résumé
BACKGROUND
Lisocabtagene maraleucel (liso-cel) is an autologous, CD19-directed, chimeric antigen receptor (CAR) T-cell product. We aimed to assess the activity and safety of liso-cel in patients with relapsed or refractory large B-cell lymphomas.
METHODS
We did a seamless design study at 14 cancer centres in the USA. We enrolled adult patients (aged ≥18 years) with relapsed or refractory large B-cell lymphomas. Eligible histological subgroups included diffuse large B-cell lymphoma, high-grade B-cell lymphoma with rearrangements of MYC and either BCL2, BCL6, or both (double-hit or triple-hit lymphoma), diffuse large B-cell lymphoma transformed from any indolent lymphoma, primary mediastinal B-cell lymphoma, and follicular lymphoma grade 3B. Patients were assigned to one of three target dose levels of liso-cel as they were sequentially tested in the trial (50 × 10
FINDINGS
Between Jan 11, 2016, and July 5, 2019, 344 patients underwent leukapheresis for manufacture of CAR
INTERPRETATION
Use of liso-cel resulted in a high objective response rate, with a low incidence of grade 3 or worse cytokine release syndrome and neurological events in patients with relapsed or refractory large B-cell lymphomas, including those with diverse histological subtypes and high-risk features. Liso-cel is under further evaluation at first relapse in large B-cell lymphomas and as a treatment for other relapsed or refractory B-cell malignancies.
FUNDING
Juno Therapeutics, a Bristol-Myers Squibb Company.
Identifiants
pubmed: 32888407
pii: S0140-6736(20)31366-0
doi: 10.1016/S0140-6736(20)31366-0
pii:
doi:
Substances chimiques
Antigens, CD19
0
Biological Products
0
axicabtagene ciloleucel
U2I8T43Y7R
Banques de données
ClinicalTrials.gov
['NCT02631044']
Types de publication
Clinical Trial
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
839-852Commentaires et corrections
Type : CommentIn
Informations de copyright
Copyright © 2020 Elsevier Ltd. All rights reserved.