Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

2-Year ZUMA-1 Results Add Support For Axicabtagene Ciloleucel In Refractory Large B-Cell Lymphoma

Long-term follow-up of axicabtagene ciloleucel-treated patients with refractory large B-cell lymphoma suggests a role for the chimeric antigen receptor T-cell therapy in this setting
05 Dec 2018
Haematological Malignancies;  Immunotherapy;  Lymphomas

Author:  By Shreeya Nanda, Senior medwireNews Reporter

medwireNews: Axicabtagene ciloleucel, a CD19-directed chimeric antigen receptor (CAR) T-cell therapy, continues to show durable responses and a manageable safety profile with longer follow-up in patients with refractory large B-cell lymphoma, report the ZUMA-1 investigators. 

They explain that the primary analysis at a median follow-up of 15.4 months showed an objective response rate (ORR) of 82% among the 108 participants of the phase I/II study after a single infusion of axicabtagene ciloleucel at a target dose of 2×106 CAR T cells/kg. 

The current analysis – published in The Lancet Oncology and presented at the 60th American Society of Hematology Annual Meeting in San Diego, California, USA – was conducted when participants had been followed up for a median 27.1 months and showed that 83% of the 101 evaluable participants had an objective response that lasted for a median of 11.1 months. 

Fifty-eight percent of the responses were complete, and for these patients the median duration of response was unreached, and 39% of patients had ongoing responses at data cutoff, note Frederick Locke, from the Moffitt Cancer Center in Tampa, Florida, USA, and co-investigators. 

The median progression-free survival duration was 5.9 months, whereas the median was not reached for overall survival (OS) and the estimated 24-month OS rate was 50.5%. 

The authors say that that these findings signify “a major improvement in clinical outcomes for these patients, for whom the expected median overall survival with conventional therapies is approximately 6 months, with a 2-year overall survival of approximately 20%.” 

They add that the safety profile with longer follow-up was “manageable” and “largely similar to that in previous reports.” 

The incidence of grade 3–5 cytokine release syndrome, infections and neurological events over the course of the study was 11%, 28% and 32%, respectively. No new cases of either cytokine release syndrome or neurological adverse events related to the CAR T-cell therapy occurred since the previous analysis, say the researchers. 

However, four patients experienced adverse events of grade 3 or 4 since then, but none were considered related to treatment. 

Frederick Locke et al conclude that “[a]xicabtagene ciloleucel can offer durable remissions to patients who otherwise lack treatment options.” 

But they add that “[a]dditional studies are needed to confirm the overall survival results noted here and to establish whether axicabtagene ciloleucel can improve quality of life in this setting.” 

The ZUMA-1 trial enrolled patients with large B-cell lymphoma – including diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma and transformed follicular lymphoma – that had not responded to the most recent chemotherapy regimen or had progressed within a year of autologous stem cell transplantation. All participants had previously received a regimen containing an anti-CD20 agent as well as an anthracycline-based chemotherapy regimen. 

Reference  

Locke FL, Ghobadi A, Jacobson CA, et al. Long-term safety and activity of axicabtagene ciloleucel in refractory large B-cell lymphoma (ZUMA-1): a single-arm, multicentre, phase 1–2 trial. Lancet Oncol; Advance online publication 2 December 2018. doi: http://dx.doi.org/10.1016/S1470-2045(18)30864-7

Last update: 05 Dec 2018

medwireNews (www.medwireNews.com ) is an independent medical news service provided by Springer Healthcare. © 2018 Springer Healthcare part of the Springer Nature group

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings