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Axi-cel improved event-free survival in R/R DLBCL

Presented by
Dr Frederick Locke, Moffitt Cancer Cancer, FL, USA
ASH 2021
Phase 3, ZUMA-7
ZUMA-7 is the first randomised CAR T-cell trial in patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL). After a median follow-up of 24.9 months, the study met its primary endpoint of event-free survival (EFS), demonstrating a statistically significant and clinically meaningful improvement with axicabtagene ciloleucel (axi-cel) compared with second-line standard-of-care [1,2].

Axi-cel is an autologous anti-CD19 CAR T-cell therapy approved for the treatment of patients with R/R DLBCL after ≥2 prior systemic therapies. Since CAR T-cell therapy may benefit patients in earlier lines of therapy, Dr Frederick Locke (Moffitt Cancer Cancer, FL, USA) and others conducted ZUMA-7 (NCT03391466), a global, randomised, open-label, phase 3 trial of axi-cel versus standard-of-care in patients with second-line R/R LBCL (n=359). Dr Locke reported the results of the primary analysis.

The primary endpoint of EFS, a composite of time to earliest date of disease progression, death from any cause, or new lymphoma therapy, was met (HR 0.40; 95% CI 0.31–0.51, P<0.0001). After a median follow-up of 24.9 months, median EFS was significantly longer with axi-cel versus standard-of-care (8.3 vs 2 months). Importantly, Kaplan-Meier estimates of the 24-months EFS rates were significantly higher with axi-cel (40.5% vs 16.3%). “This means that patients who receive either axi-cel or the standard-of-care remain in remission for 2 years after randomisation, without the need for any further therapy,” Dr Locke added.

In conclusion, axi-cel showed superiority over standard-of-care with a more than 4-fold greater median EFS, a 2.5-fold greater EFS at 2 years, and EFS improvements across key subgroups. The safety profile of axi-cel was manageable and at least consistent with third-line treatment with axi-cel in patients with R/R LBCL.

  1. Locke FL, et al. Primary Analysis of ZUMA‑7: A Phase 3 Randomized Trial of Axicabtagene Ciloleucel (Axi-Cel) Versus Standard‑of‑Care Therapy in Patients with Relapsed/Refractory Large B-Cell Lymphoma. Abstract 2, ASH 2021 Annual Meeting, 11–14 December.
  2. Locke FL, et al. N Engl J Med 2021;11 Dec. DOI: 1056/NEJMoa2116133.


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