Follow-up data from the Phase II ZUMA-5 trial showed a long-term survival benefit with axicabtagene ciloleucel (axi-cel) in patients with R/R indolent non-Hodgkin lymphoma (iNHL) who have failed two or more prior lines of therapy.
Principal investigator Sattva Neelapu, M.D., professor of Lymphoma and Myeloma, presented results from the ongoing trial at ASH 2021.
“Indolent non-Hodgkin lymphoma is a slow-developing chronic disease in which patients frequently relapse, which leads to the need for new treatment strategies,” Neelapu said. “It is encouraging to see that axi-cel provided a continued benefit over two years and may provide a lasting treatment for these patients.”
The current analysis includes 110 patients treated on the trial, including 86 with follicular lymphoma (FL) and 24 with marginal zone lymphoma (MZL) after a median follow-up of 30.9 months for FL and 23.8 months for MZL.
The treatment was well tolerated, as reported in previous studies with this therapy.
In the patients with FL, 94% had an objective response, including 79% with a complete response (CR).
The estimated duration of response (DOR) and progression-free survival (PFS) medians were 38.6 months and 39.6 months in patients with FL, respectively.
Median overall survival (OS) was not reached, but the study reported an estimated 81% OS rate at 24 months.
At data cutoff, 57% of eligible patients with FL had ongoing responses.
Among patients with MZL, 83% had an objective response, with 63% achieving a complete response.
Median DOR and OS were not reached, but patients had an estimated 70% OS rate at 24 months. Median PFS was 17.3 months.
At data cutoff, 50% of eligible patients with MZL had ongoing responses.
In March 2021, data from the ZUMA-5 study led to the first FDA approval of CAR T therapy for follicular lymphoma after two or more lines of treatment.
Watch Dr Neelapu's interview here.
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