Sattva S. Neelapu, MD, Discusses Further ZUMA-5 Follow-up on Axi-Cel for R/R iNHL

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 continuing to examine the ZUMA-5 trial (NCT03105336) of axicabtagene ciloleucel (axi-cel; Yescarta) for patients with relapsed or refractory indolent non-Hodgkin lymphoma to determine if it can result in a long-term cure. He also discussed the FDA approval of axi-cel for follicular lymphoma. 

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We would like to have further follow-up to see if these responses can last for many years and possibly even cure a subset of these patients in the long run. We know that axi-cel can potentially cure about 40% of the patients with relapsed or refractory large B-cell lymphoma.¹ We are currently doing longer follow-up on this study to see whether that is the case in indolent lymphomas as well.

To date, we’ve found that even though there’s evidence of B-cell aplasia in a subset of these patients early on, a majority do recover the normal B-cells with longer follow up. At the 2-year time point, two-thirds of these patients had recovery of normal B-cells in the peripheral blood suggesting that functional CAR T-cell persistence may not be needed to maintain durability of these responses in these patients.

Overall, the therapy has been quite well tolerated with no significant safety signals. Since the primary analysis, there were no new safety signals observed in this study. Based on the study, this therapy was approved by the United States FDA earlier this year for treatment of patients with relapsed or refractory follicular lymphoma after 2 or more lines of systemic therapy.² We’re now doing follow up in the patients with marginal zone lymphoma as well. [We’re] also actively considering how to evaluate this therapy in earlier lines of therapy for patients with indolent non-Hodgkin lymphoma.

References

1. 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

2. FDA grants accelerated approval to axicabtagene ciloleucel for relapsed or refractory follicular lymphoma. News Release. FDA. March 5, 2021. Accessed December 9, 2021. https://bit.ly/3GuB1gZ