Dr Roloff on the Real-World Outcomes of Brexu-Cel in Relapsed/Refractory B-ALL

Gregory W. Roloff, MD, hematology/oncology fellow, the University of Chicago, discusses real-world outcomes from treatment with brexucabtagene autoleucel (Tecartus; brexu-cel) in adults with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL).

Data from a retrospective, rolling-cohort study presented at the 2023 ASCO Annual Meeting showed that brexu-cel elicited high rates of complete remission (CR) with minimal residual disease (MRD) negativity in patients who received the treatment following the FDA approval of the CAR T-cell therapy in July 2020. Although investigators have data from over 30 centers in 135 patients as of June 2023, this analysis evaluated data from just 76 patients, Roloff begins.

Notably, demographics derived from the database closely resembled patients treated with brexu-cel during the phase 1/2 ZUMA-3 trial (NCT02614066), Roloff continues. These were heavily pretreated patients, and 11% who had central nervous system disease, Roloff expands.

Investigators noted high rates of CR, with 91% achieving a CR or a CR with incomplete count recovery (CRi; CR/CRi). Additionally, the 6-month progression-free survival rate was 78% among patients who were in a CR with MRD negativity. However, the 6-month PFS rate was 35% for patients who were in a CR with MRD positivity. The 6-month overall survival (OS) rates for these groups were 94% and 100%, respectively. Because this is an ongoing investigation, the OS data were not different amongst MRD-positive and MRD-negative groups, likely reflecting the efficacy of salvage treatment measures available for patients who are not obtaining an MRD-negative response, Roloff explains.

Moreover, a 50% 6-month OS rate was seen patients who did not respond to brexu-cel, Roloff concludes.