Locke Frederick L.
CONTEXT: In ZUMA-1 (NCT02348216), axicabtagene ciloleucel (axi-cel), an anti-CD19 chimeric antigen receptor (CAR) T cell therapy, demonstrated significant benefit in patients with refractory large B cell lymphoma with an objective response rate (ORR) of 82% (complete response [CR], 58%; Neelapu & Locke, et al. NEJM. 2017). These results supported the approval of axi-cel by the US FDA for the treatment of adult patients with relapsed or refractory large B cell lymphoma after ≥2 prior lines of systemic therapy. OBJECTIVE: We assessed outcomes of axi-cel by prior lines of therapy (LoT) in patients from Phases 1 and 2 of ZUMA-1. DESIGN: Patients with refractory large B cell lymphoma were leukapheresed and received 2×106 CAR T cells/kg after low-dose conditioning (Neelapu & Locke, et al. NEJM 2017). Patients were evaluated by number of prior LoT: 2-3 vs ≥4. Autologous stem cell transplant (ASCT) was considered a prior LoT. RESULTS: As of 8/11/17, median follow-up was 15.4 months for the 108 patients treated with axi-cel. Sixty-two patients (57%) had 2-3 prior LoT, and 43 (40%) had ≥4. Patients with 2-3 and ≥4 prior LoT had median ages of 60 and 55 years; 65% and 47% had ECOG performance status of 1, 18% and 42% had prior ASCT, and 76% and 93% had disease stage III/IV, respectively. ORRs were 94% (CR, 65%) and 67% (CR, 53%) for patients with 2-3 and ≥4 prior LoT, respectively, and 44% and 42% of patients had ongoing responses as of the data cutoff. Overall survival (OS) at 12 months was 65% and 51% for patients with 2-3 and ≥4 prior LoT, respectively. Grade ≥3 treatment-emergent adverse events were reported for nearly all (100% and 93%) patients with 2-3 and ≥4 LoT, with similar rates of Grade ≥3 cytokine release syndrome (11% and 12%) and neurologic events (32% and 30%). There were 1 and 3 Grade 5 adverse events unrelated to disease progression in the 2-3 and ≥4 LoT groups, respectively. CONCLUSIONS: Axi-cel demonstrated long-term clinical benefit for patients with refractory large B cell lymphoma regardless of the number of prior LoT. FUNDING SOURCE: Kite, a Gilead Company
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