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2024-08-02T12:56:05.000Z

Brexu-cel for patients with R/R B-ALL: 4-year follow-up from the ZUMA-3 trial

Aug 2, 2024
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Learning objective: After reading this article, learners will be able to cite a new clinical development in relapsed/refractory acute lymphoblastic leukemia.


The phase I/II ZUMA-3 trial (NCT02614066) assessed the safety and efficacy of brexucabtagene autoleucel (brexu-cel), an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, in adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL).1 The ALL Hub previously reported 2-year follow-up results from this trial. Based on results from this trial, brexu-cel was approved by the U.S. Food and Drug Administration (FDA) and the European Commission for the treatment of patients with R/R B-ALL aged ≥18 and ≥26 years, respectively. Long-term survival outcomes with a 4-year follow-up from this trial were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting by Oluwole.1  


Key learnings

The median overall survival (OS) was 25.6 and 47.0 months for all phase I and phase II treated patients (n = 78), and patients who achieved a complete response (CR) or CR with incomplete count recovery (n = 57), respectively. 

Median OS was similar for all treated patients with that across various subgroups, including for patients aged <26 years (n = 15; 23.2 months), aged ≥26 years (n = 63; 26.0 months), and patients with ≥2 prior lines of therapy (n = 63; 25.4 months), and was higher in patients with 1 prior line of therapy (n = 15; 60.4 months). 

Among patients with ≥2 prior lines of therapy, patients with prior blinatumomab (n = 37) had a lower median OS vs those without (n = 26; 16.1 vs 47.0 months), and among responders, patients who did not proceed to subsequent allogeneic hematopoietic stem cell transplantation (allo-HSCT; n = 43) had a higher median OS than those who did (n = 14; 60.4 vs 36.3 months). 

The 48-month OS rate was 40% in all treated patients and was similar across most subgroups but lower in patients with prior blinatumomab (n = 38; 24%) and prior inotuzumab (n = 17; 21%) and higher in patients without prior blinatumomab (n = 38; 55%) and with 1 prior line of therapy (57%). 

No new safety signals were observed. 

These long-term survival outcomes confirm the benefit of brexu-cel in patients with R/R B-ALL, irrespective of age, number of prior therapy lines, or subsequent allo-HSCT.  


  1. Oluwole OO. Long-term survival outcomes of patients (pts) with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) treated with brexucabtagene autoleucel (brexu-cel) in ZUMA-3. Abstract #6531. Presented at: 2024 American Society of Clinical Oncology Annual Meeting; May 30 – Jun 3, 2024; Chicago, US. 

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