Sattva S. Neelapu, MD, spoke about the ZUMA-5 trial and the long-term follow-up results seen with axicabtagene ciloleucel in patients with relapsed or refractory indolent non-Hodgkin lymphoma.
At the 2021 American Society of Hematology Annual Meeting, Sattva S. Neelapu, MD, a professor in the Department of Lymphoma and Myeloma, Division of Cancer Medicine at the University of Texas MD Anderson Cancer Center, discussed prior results from the ZUMA-5 trial (NCT03105336) that looked at axicabtagene ciloleucel (Axi-cel; Yescarta) for patients with relapsed or refractory indolent non-Hodgkin lymphoma. Neelapu also discussed the updated long-term results seen after 2 years of follow-up and which results he was most surprised to see.
The ZUMA-5 [trial] is a phase 2 single-arm multicenter study that was conducted in [the United States] and Europe. [This was] conducted in patients with relapsed or refractory indolent non-Hodgkin lymphoma to evaluate the efficacy of axicabtagene ciloleucel, which is an anti-CD19 CAR T-cell therapy product.
At ASH 2020, we presented the primary analysis from this pivotal registration trial, where we found a very high overall response rate and CR [complete response] rate in these patients.1 The median duration of response and progression-free survival [PFS] was not reached. The primary analysis was conducted with at least 80 patients with follicular lymphoma and had a minimum follow-up of 12 months.
At ASH 2021, we are presenting a longer follow-up on this study, where at least 80 patients with follicular lymphoma had a minimum of 2 years of follow-up.2 We enrolled and treated a total of 149 patients, with 124 of them having follicular lymphoma, and 25 having marginal zone lymphoma. In this updated long-term follow-up analysis, there were a total of 110 efficacy-eligible patients, 86 with follicular lymphoma, and 24 with marginal zone lymphoma. The best overall response rate and the complete response rate in the follicular lymphoma cohort was 94% and 79%, respectively. In the marginal zone lymphoma cohort, the overall response rate was 83%, and the complete response rate was 63%. These responses were quite consistent across various key prognostic subgroups, and after median follow-up of 31 months in the follicular lymphoma cohort, we found that the median duration response and PFS is almost 40 months, and 57% of patients with follicular lymphoma had ongoing response at data cutoff. For marginal zone lymphoma, 50% of the patients had ongoing response at data cutoff. The median overall survival was not reached for either cohort.
We found that estimated PFS and duration of response appeared to improve with longer follow-up for both follicular lymphoma and marginal zone lymphoma. Importantly, in marginal zone lymphoma, the median duration of response and PFS [follow-up] is about 18 months now, and 50% of those responses were ongoing. I think this is quite encouraging. Overall, it indicates that axi-cel is highly effective for these patients.
1. Jacobson C, Chavez J, Sehgal A, et al. Primary Analysis of Zuma-5: A Phase 2 Study of Axicabtagene Ciloleucel (Axi-Cel) in Patients with Relapsed/Refractory (R/R) Indolent Non-Hodgkin Lymphoma (iNHL). Blood. 136(suppl 1):40-41. doi.10.1182/blood-2020-136834
2. Neelapu S, Chavez J, Sehgal A, et al. Long-Term Follow-up Analysis of ZUMA-5: A Phase 2 Study of Axicabtagene Ciloleucel (Axi-Cel) in Patients with Relapsed/Refractory (R/R) Indolent Non-Hodgkin Lymphoma (iNHL). Presented at: 63rd American Society of Hematology Annual Conference. December 11-14, 2021. Abstract 93. Accessed December 9, 2021. https://bit.ly/31Gnfcl