Title :

Three-Year Follow-Up Analysis of Axicabtagene Ciloleucel in Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (ZUMA-5).

Author(s) :

Neelapu, Sattva S. [Auteur]
The University of Texas M.D. Anderson Cancer Center [Houston]
Chavez, Julio C. [Auteur]
H. Lee Moffitt Cancer Center and Research Institute
Sehgal, Alison R. [Auteur]
University of Pittsburgh Medical Center [Pittsburgh, PA, États-Unis] [UPMC]
Epperla, Narendranath [Auteur]
Ohio State University [Columbus] [OSU]
Ulrickson, Matthew L. [Auteur]
MD Anderson Cancer Center [Houston]
Bachy, Emmanuel [Auteur]
Centre Hospitalier Lyon Sud [CHU - HCL] [CHLS]
Munshi, Pashna [Auteur]
Georgetown Lombardi Comprehensive Cancer Center
Casulo, Carla [Auteur]
University of Rochester Medical Center [URMC]
Maloney, David G. [Auteur]
De Vos, Sven [Auteur]
University of California [Los Angeles] [UCLA]
Reshef, Ran [Auteur]
Columbia University Irving Medical Center [CUIMC]
Leslie, Lori A. [Auteur]
Hackensack Meridian Health
Oluwole, Olalekan O. [Auteur]
Vanderbilt University Medical Center [Nashville]
Yakoub-Agha, Ibrahim [Auteur]
Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286
Khanal, Rashmi [Auteur]
Fox Chase Cancer Center
Rosenblatt, Joseph D. [Auteur]
University of Miami
Korn, Ronald [Auteur]
Peng, Weixin [Auteur]
Lui, Christine [Auteur]
Wullf, Jacob [Auteur]
Shen, Rhine R. [Auteur]
Poddar, Soumya [Auteur]
Jung, A. Scott [Auteur]
Miao, Harry [Auteur]
Beygi, Sara [Auteur]
Jacobson, Caron A. [Auteur]
Dana-Farber Cancer Institute [Boston]

Journal title :

Blood

Abbreviated title :

Blood

Publication date :

2023-10-26

ISSN :

1528-0020

HAL domain(s) :

Sciences du Vivant [q-bio]

English abstract : [en]

Axicabtagene ciloleucel (axi-cel) is an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy approved for relapsed/refractory (R/R) follicular lymphoma (FL). Approval was supported by the phase 2, multicenter, ...
Show more >Axicabtagene ciloleucel (axi-cel) is an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy approved for relapsed/refractory (R/R) follicular lymphoma (FL). Approval was supported by the phase 2, multicenter, single-arm ZUMA-5 study of axi-cel for patients with R/R indolent non-Hodgkin lymphoma (iNHL; N = 104), including FL and marginal zone lymphoma (MZL). In the primary analysis (median follow-up, 17.5 months), the overall response rate (ORR) was 92% (complete response rate, 74%). Here, we report long-term outcomes from ZUMA-5. Eligible patients with R/R iNHL after ≥2 lines of therapy underwent leukapheresis, followed by lymphodepleting chemotherapy and axi-cel infusion (2 × 106 CAR T cells per kg). The primary end point was ORR, assessed in this analysis by investigators in all enrolled patients (intent-to-treat). After median follow-up of 41.7 months in FL (n = 127) and 31.8 months in MZL (n = 31), ORR was comparable with that of the primary analysis (FL, 94%; MZL, 77%). Median progression-free survival was 40.2 months in FL and not reached in MZL. Medians of overall survival were not reached in either disease type. Grade ≥3 adverse events of interest that occurred after the prior analyses were largely in recently treated patients. Clinical and pharmacokinetic outcomes correlated negatively with recent exposure to bendamustine and high metabolic tumor volume. After 3 years of follow-up in ZUMA-5, axi-cel demonstrated continued durable responses, with very few relapses beyond 2 years, and manageable safety in patients with R/R iNHL. The ZUMA-5 study was registered at www.clinicaltrials.gov as #NCT03105336.Show less >

Language :

Anglais

Audience :

Internationale

Popular science :

Non

Administrative institution(s) :

Université de Lille
Inserm
CHU Lille

Collections :

• Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286

Submission date :

2024-02-06T22:23:30Z
2024-03-19T10:04:50Z