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ZUMA-12: 3-year follow-up analysis of axi-cel in high-risk large B-cell lymphoma
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The primary analysis of the ZUMA-12 trial (NCT03761056) showed that axi-cel achieved a CRR of 78% in patients with high-risk LBCL (N = 37), with no new safety signals observed.1 Results from the 3-year follow-up analysis of the trial evaluating the long-term efficacy and safety of axi-cel in patients with high-risk LBCL were published by Chavel et al.1 in Blood Advances. The primary endpoint was investigator-assessed CRR. Key secondary endpoints included DOR, EFS, PFS, OS, and safety.1 |
| Key learnings |
| After a median follow-up of 47.0 months, the CRR and ORR were 86% (95% CI, 71–95) and 92%, respectively, among evaluable patients (n = 37). In patients with double- or triple-hit lymphoma with IPI ≤2 (n = 5), the CRR was 83%. |
| The median DOR was not reached, and the 36-month ongoing response rate was 81.8% (95% CI, 63.9–91.4). The 36-month estimated EFS, PFS, and OS rates were 73.0% (95% CI, 55.6–84.4), 75.1% (95% CI, 57.5–86.2), and 81.1% (95% CI, 64.4–90.5), respectively. |
| No new safety signals were reported. Malignancies were reported in four patients, none of which were related to axi-cel. Deaths were reported in eight patients due to disease progression (n = 5), NRM (n = 2), and sepsis (n = 1). |
| These findings show the potential of axi-cel as an effective first-line therapy for patients with high-risk LBCL, with high and durable response rates and a manageable safety profile. The phase III ZUMA-23 trial (NCT05605899) is currently recruiting and will evaluate axi-cel vs SOC. |
Abbreviations: axi-cel, axicabtagene ciloleucel; CI, confidence interval; CRR, complete response rate; DOR, duration of response; EFS, event-free survival; IPI, International Prognostic Index; LBCL, large B-cell lymphoma; NRM, non-relapse mortality; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; SOC, standard of care.
- Chavez JC, Dickinson M, Munoz J, et al. Three-year follow-up analysis of first-line axicabtagene ciloleucel in high-risk large B-cell lymphoma (ZUMA-12). Blood. 2025. Online ahead of print. DOI: 10.1182/blood.2024027347
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