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ZUMA-5: 5-year follow-up analysis of axicabtagene ciloleucel in patients with R/R iNHL
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Axi-cel, a CD19-directed chimeric antigen receptor T-cell therapy, was approved by the European Commission for the treatment of patients with R/R FL based on results from the phase II ZUMA-5 trial (NCT03105336). ZUMA-5 is a multicenter trial evaluating the efficacy and safety of axi-cel in patients with R/R iNHL, including FL and MZL, who have failed ≥2 prior lines of therapy. 5-year follow-up results from the trial (N = 159; FL: n = 127 for efficacy, n = 124 for safety; MZL: n = 31 for efficacy, n = 28 for safety) were presented at the 66th ASH Annual Meeting and Exposition by Neelapu.1 |
| Key learnings |
| The ORR was 90%; 94% in patients with FL and 77% in patients with MZL. The CR rate was 75% overall; 79% in patients with FL and 65% in patients with MZL. |
| The median PFS was 62.2 months overall, and 57.3% in patients with FL. The 60-month PFS rates were 50.4% overall and 49.8% in patients with FL, regardless of high-risk factors including POD24. |
| The median OS was not reached, with a 60-month OS rate of 69.0% overall. In patients with FL, the 60-month lymphoma-specific OS rate was 83.4%. The median DoR was 60.4 months, with a 60-month DoR of 53.4%. |
| Safety outcomes were consistent with previous analyses, with no new safety signals reported. |
| This 5-year follow-up of the ZUMA-5 trial demonstrates durable responses of axi-cel in patients with R/R iNHL, with curative potential in patients with R/R FL and promising efficacy in high-risk R/R FL. |
Abbreviations: Axi-cel, axicabtagene ciloleucel; CR, complete response; DoR, duration of response; FL, follicular lymphoma; iNHL, indolent non-Hodgkin lymphoma; MZL, marginal zone lymphoma; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; R/R, relapsed/refractory.
- Neelapu SS. 5-year follow-up analysis from ZUMA-5: A phase II trial of axicabtagene ciloleucel (axi-cel) in patients with relapsed/refractory indolent non-Hodgkin lymphoma. Oral Abstract #864. Presented at: 66th American Society of Hematology Annual Meeting and Exposition; Dec 7–10, 2024; San Diego, US.
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