Five-Year Follow-Up Analysis of ZUMA-5: Axicabtagene Ciloleucel in Relapsed/Refractory Indolent Non-Hodgkin Lymphoma

S Sattva S. Neelapu J Julio C. Chavez (4Moffitt Cancer Center, Tampa, FL) A Alison R. Sehgal (UPMC Hillman Cancer Center, Pittsburgh, PA) N Narendranath Epperla (University of Utah, Salt Lake City, Utah, United States) M Matthew L. Ulrickson (3Section of Hematology, Banner MD Anderson Cancer Center, Gilbert, AZ) E Emmanuel Bachy P Pashna N. Munshi (Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA) C Carla Casulo (18Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY) D David G. Maloney (Fred Hutchinson Cancer Center, Seattle, Washington, United States) S Sven de Vos (7Department of Medicine, Hematology/Oncology, Ronald Reagan University of California Los Angeles Medical Center, Los Angeles, CA) R Ran Reshef (13Division of Hematology/Oncology, Blood and Marrow Transplantation and Cell Therapy Program, Columbia University Irving Medical Center, New York, NY) L Lori A. Leslie (John Theurer Cancer Center, Hackensack, NJ) O Olalekan O. Oluwole I Ibrahim Yakoub-Agha (9CHU de Lille, Univ Lille, INSERM U1286, Infinite, 59000 Lille, Lille, France) R Rashmi Khanal (1Temple University Hospital, Philadelphia, United States) J Joseph D. Rosenblatt (University of Miami Sylvester Comprehensive Cancer Center, Miami, FL) J Jacob Wulff (3Kite Pharmaceuticals, Santa Monica, United States) R Rhine R. Shen (19Kite, a Gilead company, Santa Monica, CA) W Wangshu Zhang (19Kite, a Gilead company, Santa Monica, CA) S Soumya Poddar (Kite, a Gilead Company, Santa Monica, California, United States) H Harry Miao (Kite, a Gilead Company, Santa Monica, CA) O Olga Nikolajeva (6Kite, a Gilead Company, Santa Monica, United States) C Caron A. Jacobson (5Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA)

Abstract

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). Here, we report updated clinical outcomes from ZUMA-5 in 159 enrolled patients with R/R indolent non-Hodgkin lymphoma (iNHL; 127 with FL and 31 with marginal zone lymphoma) after a median follow-up of 64.6 months. Patients underwent leukapheresis and received lymphodepleting chemotherapy and axi-cel (2 × 10 6 CAR T cells/kg). The overall response rate was 90% (75% complete response rate). The median duration of response was 60.4 months, and the median progression-free survival (PFS) was 62.2 months; median time to next treatment and overall survival were not reached (NR). At data cutoff, 55% of patients were alive without requiring subsequent anticancer therapy. Median lymphoma-specific PFS in patients with FL was NR; 34% had progression or death due to lymphoma or study treatment. Notably, after 30 months postinfusion, progression or lymphoma-related deaths were rare. Late-onset toxicities were infrequent and largely unrelated to axi-cel. Durable response and prolonged survival in FL were associated with robust early CAR T-cell expansion and naïve product phenotype. These findings confirm sustained responses and manageable safety with axi-cel in the long term among patients with R/R iNHL and its potential as a curative therapy in FL.

Article Details

Volume / Issue Vol. 43, Issue 33
Published November 20, 2025
Pages 3573-3577
ISSN 0732-183X
Publisher Lippincott Williams & Wilkins

Journal Info

Journal of Clinical Oncology

Lippincott Williams & Wilkins

ISSN: 0732-183X Health Sciences

Authors (23)

S

Sattva S. Neelapu

J

Julio C. Chavez

4Moffitt Cancer Center, Tampa, FL

A

Alison R. Sehgal

UPMC Hillman Cancer Center, Pittsburgh, PA

N

Narendranath Epperla

University of Utah, Salt Lake City, Utah, United States

M

Matthew L. Ulrickson

3Section of Hematology, Banner MD Anderson Cancer Center, Gilbert, AZ

E

Emmanuel Bachy

P

Pashna N. Munshi

Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA

C

Carla Casulo

18Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY

D

David G. Maloney

Fred Hutchinson Cancer Center, Seattle, Washington, United States

S

Sven de Vos

7Department of Medicine, Hematology/Oncology, Ronald Reagan University of California Los Angeles Medical Center, Los Angeles, CA

R

Ran Reshef

13Division of Hematology/Oncology, Blood and Marrow Transplantation and Cell Therapy Program, Columbia University Irving Medical Center, New York, NY

L

Lori A. Leslie

John Theurer Cancer Center, Hackensack, NJ

O

Olalekan O. Oluwole

I

Ibrahim Yakoub-Agha

9CHU de Lille, Univ Lille, INSERM U1286, Infinite, 59000 Lille, Lille, France

R

Rashmi Khanal

1Temple University Hospital, Philadelphia, United States

J

Joseph D. Rosenblatt

University of Miami Sylvester Comprehensive Cancer Center, Miami, FL

J

Jacob Wulff

3Kite Pharmaceuticals, Santa Monica, United States

R

Rhine R. Shen

19Kite, a Gilead company, Santa Monica, CA

W

Wangshu Zhang

19Kite, a Gilead company, Santa Monica, CA

S

Soumya Poddar

Kite, a Gilead Company, Santa Monica, California, United States

H

Harry Miao

Kite, a Gilead Company, Santa Monica, CA

O

Olga Nikolajeva

6Kite, a Gilead Company, Santa Monica, United States

C

Caron A. Jacobson

5Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA