Outcomes of second‐line axicabtagene ciloleucel for large B‐cell lymphoma in the UK

Following approval of axicabtagene ciloleucel (axi-cel) as second-line (2 L) treatment for large B-cell lymphoma (LBCL), results from real-world CAR T cohorts will be key to confirm safety and efficacy in standard practice. We present comprehensive clinical outcomes of LBCL patients intended to be treated with 2 L axi-cel through the UK National CAR T service. Of 345 patients approved for 2 L axi-cel, 302 (87.5%) were infused. The median age was 62 years (range 22-78); 21% were over 70 years. 75% of patients were approved for CAR T within 3 months from end of first-line (1 L) therapy. 42% of patients required pre-apheresis holding therapy, and 97% received bridging therapy. The best overall response rate was 86% (64% complete response). The 12-month OS was 73.9% (95% CI: 68.3-78.7) for infused patients and 1.5 months (0.9-3.0) for patients not proceeding to CAR T. The 12-month PFS was 52.4% (46.3-58.0). In multivariable analysis, advanced stage, male sex, no response to 1 L therapy, high LDH, and high CRP pre-infusion were independently associated with PFS. Grade ≥3 CRS and ICANS rates were 5% and 18%, respectively. Outcomes in patients aged ≥70 years were similar to the younger population. In this large UK real-world cohort of 2 L axi-cel in LBCL, we demonstrate efficacy and toxicity outcomes comparable to the pivotal ZUMA-7 trial, despite 42% patients requiring urgent holding therapy. Outcomes were favorable in patients aged ≥70 years, supporting the use of 2 L CAR T in older fit patients.

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Publication Details

Journal
HemaSphere
Published
2026-02-01
DOI
https://doi.org/10.1002/hem3.70312
Primary Topic
CAR-T cell therapy research
Type
article
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article

Outcomes of second‐line axicabtagene ciloleucel for large B‐cell lymphoma in the UK

Caroline Besley, Francesca Sillito, Rajesh Alajangi, Jane E. Norman et al.
HemaSphere
CAR-T cell therapy research
article

Outcomes of second‐line axicabtagene ciloleucel for large B‐cell lymphoma in the UK

Caroline Besley, Francesca Sillito, Rajesh Alajangi, Jane E. Norman, Hwai Jing Hiew, Nada Fadlelmula, Nicolás Martínez‐Calle, Pierre C. McCarthy, Thomas Creasey, Emil Kumar, Vaishali Dulobdas, Edward Bataillard, Amy Kirkwood, Mary Owen, Aikaterini Panopoulou, Wendy Osborne, Andrew John Davies, Ceri Jones, Alison Delaney, Tobias Menne, Kushani Ediriwickrema, Ben Uttenthal, Bernard Maybury, Angharad Pryce, Olateni Awofisayo, Joseph Froggatt, Mary Warren, Michael Northend, Muddeha Waraich, Dr Ram Malladi, Shenbagaram Kasivisvanathan, L. Gajendran, Sridhar Chaganti, Amrith Mathew, Ahmed Abdulgawad, William Townsend, Maeve O'Reilly, Robert P. Wilson, Graham P. Collins, Andrea Kuhnl, Shankara Paneesha, Adrian Maraj, Dima El‐Sharkawi, Frances Seymour, John G. Gribben, Robin Sanderson, Kate Cwynarski, Claire Roddie
article en

Abstract

Following approval of axicabtagene ciloleucel (axi-cel) as second-line (2 L) treatment for large B-cell lymphoma (LBCL), results from real-world CAR T cohorts will be key to confirm safety and efficacy in standard practice. We present comprehensive clinical outcomes of LBCL patients intended to be treated with 2 L axi-cel through the UK National CAR T service. Of 345 patients approved for 2 L axi-cel, 302 (87.5%) were infused. The median age was 62 years (range 22-78); 21% were over 70 years. 75% of patients were approved for CAR T within 3 months from end of first-line (1 L) therapy. 42% of patients required pre-apheresis holding therapy, and 97% received bridging therapy. The best overall response rate was 86% (64% complete response). The 12-month OS was 73.9% (95% CI: 68.3-78.7) for infused patients and 1.5 months (0.9-3.0) for patients not proceeding to CAR T. The 12-month PFS was 52.4% (46.3-58.0). In multivariable analysis, advanced stage, male sex, no response to 1 L therapy, high LDH, and high CRP pre-infusion were independently associated with PFS. Grade ≥3 CRS and ICANS rates were 5% and 18%, respectively. Outcomes in patients aged ≥70 years were similar to the younger population. In this large UK real-world cohort of 2 L axi-cel in LBCL, we demonstrate efficacy and toxicity outcomes comparable to the pivotal ZUMA-7 trial, despite 42% patients requiring urgent holding therapy. Outcomes were favorable in patients aged ≥70 years, supporting the use of 2 L CAR T in older fit patients.

HemaSphereVol. 10(2)
Imperial College Healthcare NHS Trust (GB), Queen Mary University of London (GB), Leeds Teaching Hospitals NHS Trust (GB), University Hospitals Bristol NHS Foundation Trust (GB), University Hospital of Wales (GB), Royal London Hospital (GB), Freeman Hospital (GB), Manchester Royal Infirmary (GB), Cambridge University Hospitals NHS Foundation Trust (GB), University Hospital Southampton NHS Foundation Trust (GB), Sheffield Teaching Hospitals NHS Foundation Trust (GB), St George's Hospital (GB), Royal Marsden Hospital (GB), The Christie Hospital (GB), NIHR Surgical Reconstruction and Microbiology Research Centre (GB), Oxford University Hospitals NHS Trust (GB), CRUK Lung Cancer Centre of Excellence (GB), King's College Hospital (GB), University College London (GB)
Good health and well-being
Openalex Percentile: Top 48%
CAR-T cell therapy research
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