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CD19-targeted chimeric antigen receptor (CAR) T-cell therapies have significantly advanced the treatment landscape for relapsed/refractory (R/R) large B-cell lymphoma (LBCL). Based on results from the ZUMA-1 trial, axicabtagene ciloleucel (axi-cel) was initially approved for R/R LBCL following ≥2 lines of systemic therapy; it has more recently been indicated for R/R LBCL within 12 months of first-line chemoimmunotherapy, based on outcomes from the ZUMA-7 trial.
The 2-year outcomes of the ZUMA-1 trial (NCT02348216), previously reported on the Lymphoma Hub, demonstrated an 83% objective response rate, 58% complete response (CR) rate, a manageable safety profile, ongoing responses in 39%, and median overall survival (OS) was not reached. Moreover, comparable outcomes to ZUMA-1 have been reported in real-world analyses.
Below, we summarize an article published by Neelapu et al.1 in Blood on the 5-year efficacy and safety outcomes of phase II ZUMA-1 trial, which included an analysis of the durability responses and long-term survival benefit.
The study design, treatment procedures, eligibility criteria, and baseline and patient characteristics for phase II of the ZUMA-1 study were previously reported on the Lymphoma Hub.
Of the 111 patients enrolled in the phase II study, 101 were treated with axi-cel; 84% of these patients had lactate dehydrogenase levels above the upper limit of normal. At the data cut off (August 11, 2021) and a median follow-up of 63.1 months, durable responses were observed (Figure 1). The median DOR was 11.1 months, median duration of CR was 62.2 months, and median duration of PR was 1.9 months. Median DOR was 34.7 months in those with CR by Week 4 and not reached in those who achieved a CR after Week 4.
Figure 1. Response rates*
CR, complete response; PR, partial response
*Data from Neelapu, et al.1
The survival outcomes at the data cut off were as follows:
At the 5-year follow-up, no new safety signals and no new axi-cel-related serious AEs were reported, with a safety profile comparable to previous analyses.
Among the biomarker-evaluable patients (n = 97):
This additional follow-up analysis of the ZUMA-1 trial demonstrated the clinical survival benefit and manageable safety profile of axi-cel in patients with refractory LBCL. Moreover, the pharmacokinetic profile showed polyclonal B-cell recovery in a large proportion of patients, with ongoing responses at the 3-year mark, as well as an association between durable responses at the 5-year mark and early CAR T-cells expansion. Overall, these data support the use of axi-cel in aggressive B-cell lymphomas with curative intent.
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The Lymphoma Hub is happy to present a Visual Abstract representing key data from the primary analysis of the phase III ZUMA-7 study (NCT03391466), evaluating the clinical efficacy of axicabtagene...
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