Shah BD, Ghobadi A, Oluwole OO, et al. KTE-X19 for Relapsed or Refractory Adult B-Cell Acute Lymphoblastic Leukemia: Phase 2 Results of the Single-Arm, Open-Label, Multicentre ZUMA-3 Study. The Lancet. 2021; (doi: 10.1016/S0140-6736(21)01222-8).
Adult patients with relapsed or refractory B-precursor acute lymphoblastic leukemia who were treated with KTE-X19 experienced a high rate of complete remission or complete remission without complete hematological recovery, according to new research. For the international trial, 55 adult patients each received a single infusion of KTE-X19 — an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy — following leukapheresis and conditioning chemotherapy. At a median follow-up of 16.4-months, 39 patients (71%) saw complete remission or complete remission with incomplete hematological recovery, with 31 (56%) achieving complete remission. The median duration of remission was 12.8 months, while the median relapse-free survival was 11.6 months and median overall survival was 18.2 months. The median overall survival was not reached in responding patients, and 97% did not have minimal residual disease. Ten patients (18%) underwent allogeneic stem cell transplantation consolidation following KTE-X19 infusion. Anemia and pyrexia were the most frequently occurring common grade 3 or higher adverse events. Fourteen patients (25%) had grade 3 or higher infections, while 13 (24%) had grade 3 or higher cytokine release syndrome. The results suggest that KTE-X19 could provide a long-term clinical benefit for this population.