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Axicabtagene ciloleucel (axi-cel) is an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy with a CD28 transmembrane/co-stimulatory domain, approved for the treatment of relapsed/refractory (R/R) large B-cell lymphoma after ≥2 prior therapies. Approval was based on the phase I/II ZUMA-1 (NCT02348216) trial results.
Positive results from the 2-year analysis of the ZUMA-1 trial were previously reported on the Lymphoma Hub, where 83% of patients responded, 58% achieved a complete response, and 39% had ongoing responses after a median follow-up of 27.1 months.
Here, we report the survival outcomes and recovery of polyclonal B cells for ongoing responders with 4 years of follow-up from this phase II trial, as presented by Caron Jacobson during the 47th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT).1
Time to response (as previously reported in the 2-year follow-up), time to next anticancer therapy, and overall survival (OS) after ≥4 years of follow up are shown in Table 1.
Table 1. Time to response, time to next therapy, median OS, and 4-year OS rates*
Response |
ITT population |
MITT population |
---|---|---|
Median time to OR, months (range) |
1.7 (0.7–12.9) |
1 (1–12) |
Median time to CR, months (range) |
1.9 (0.7–13.3) |
1 (1–12) |
Median time to next therapy, months (range)† |
— |
8.7 (0.3–53.8) |
Median OS, months |
17.4 |
25.8 |
KM estimate of 4-year OS rate, % |
41 |
44 |
CR, complete response; ITT, intention to treat; KM, Kaplan Meier; MITT, modified intention to treat; OR, objective response; OS, overall survival. |
In this long-term follow-up of the ZUMA-1 trial, axi-cel demonstrated deep and durable responses, with a 4-year OS rate of 44% among treated patients. The short time between enrolment and response, as previously observed, demonstrates the speed at which the therapy takes effect.
Moreover, patients with ongoing responses at ≥3 years of follow-up showed evidence of polyclonal B-cell restoration and clearance of functional CAR-T cells, which is a key component of the long-term safety of CD19-directed CAR T-cell therapy. This also supports the idea that persistence of functional CAR T cells is not necessary for deep and durable remission in large B-cell lymphoma.
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