Protracted B-cell aplasia was not required for durable responses. In conclusion, this 5-year follow-up analysis of ZUMA-1 demonstrates sustained overall and disease-specific survival, with no new safety signals in patients with refractory LBCL. Ongoing responses at 60 months were associated with early CAR T-cell expansion. Peripheral blood B cells were detectable in all evaluable patients at 3 years with polyclonal B-cell recovery in 91% of patients. No new serious adverse events or deaths related to axi-cel were observed after additional follow-up. Disease-specific survival (excluding deaths unrelated to disease progression) estimated at 5 years was 51.0%. Median overall survival (OS) was 25.8 months, and the estimated 5-year OS rate was 42.6%. The objective response rate in these 101 patients was 83% (58% complete response rate) with a median follow-up of 63.1 months, responses were ongoing in 31% of patients at data cutoff. Investigator-assessed response, survival, safety, and pharmacokinetics were assessed in patients who had received treatment. Eligible adults received lymphodepleting chemotherapy followed by axi-cel (2 × 10 6 cells per kg). Here, we assessed outcomes in ZUMA-1 after 5 years of follow-up. In phase 2 of ZUMA-1, a single-arm, multicenter, registrational trial, axicabtagene ciloleucel (axi-cel) autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy demonstrated durable responses at 2 years in patients with refractory large B-cell lymphoma (LBCL).

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