ZUMA-7: A phase 3 randomized trial of axicabtagene ciloleucel (Axi-Cel) versus standard-of-care (SOC) therapy in patients with relapsed/refractory diffuse large B cell lymphoma (R/R DLBCL).

TPS7585Background: For pts with DLBCL who fail 1st-line therapy, the only potentially curative treatment is salvage chemotherapy followed by autologous stem cell transplant (ASCT). Only »50% of pts receiving salvage chemotherapy proceed to ASCT and 3-y progression-free survival (PFS) is 53% after ASCT (Gisselbrecht et al. JCO. 2010). In ZUMA-1, the pivotal, single-arm study of axi-cel, an autologous anti-CD19 chimeric antigen receptor (CAR) T cell therapy, the objective response rate (ORR) was 82% (58% complete response [CR] rate) in pts with refractory large B cell lymphoma; 40% remained in CR with 15.4-mo median follow-up (Neelapu & Locke et al. NEJM. 2017). This trial was primarily in pts with ≥ 2 prior lines of therapy and supported US FDA approval of axi-cel for the treatment of adult pts with R/R DLBCL after ≥ 2 prior lines of systemic therapy. ZUMA-7 investigates axi-cel as 2nd-line therapy for pts with R/R DLBCL. Methods: ZUMA-7 (NCT03391466) is a randomized (1:1) Phase 3, open-label, multicenter ...