Multicenter study of brexucabtagene autoleucel as standard therapy for relapsed/refractory B-cell ALL in adults

Based on results of the ZUMA-3 trial, the CD19-directed CAR T-cell therapy brexucabtagene autoleucel (brexu-cel) gained FDA approval in October 2021 for R/R B-ALL in adult patients. The ROCCA (‘real-world outcomes collaborative of CAR-T in adult ALL’) Consortium, a collaboration of 31 centers in the USA, evaluated brexu-cel as a standard therapy outside the context of a clinical trial. At the time of data lock, 204 patients had undergone apheresis, and 189 were infused Forty-two percent of patients received brexu-cel in morphologic remission and would have been ineligible ZUMA-3. After brexu-cel, 151 (79.9%) achieved complete remission, of which 119 (79%) were MRD negative remissions. Median PFS was 9.5 months and median OS was not reached. Grade 3-4 CRS or ICANS occurred in 11% and 31%, respectively. In multivariate analysis, patients receiving consolidative HCT after brexu-cel had superior PFS compared with those who did not receive any consolidation or maintenance therapy (HR 0.34; 95% CI 0.14-0.85). The authors conclude that brexu-cel in clinical practice results in high rates of MRD-negative complete remission among adult patients with R/R B-ALL.