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CAR-T Therapy Brexucabtagene Autoleucel is a Treatment Option in R/R B-ALL
CAR-T-cell therapy brexucabtagene autoleucel may offer a treatment option for patients with relapsed or refractory (R/R) B-precursor acute lymphoblastic leukemia (B-ALL), according to results from the phase 2 ZUMA-3 trial. The median age of treated patients in the trial was 40.
“Despite treatment with novel therapies and allogeneic stem-cell transplant (allo-SCT) consolidation, outcomes in adult patients with R/R B-precursor ALL remain poor, underlining the need for more effective therapies,” wrote Bijal D Shah, MD, Moffitt Cancer Center, Tampa, Florida, and the co-authors.
In ZUMA-3, 71 patients were enrolled from 25 sites in the USA, Canada, and Europe between Oct 1, 2018, and Oct 9, 2019. Brexucabtagene autoleucel was approved for use in the U.S. in July 2020. However, brexucabtagene autoleucel was successfully manufactured for only 65 (92%) patients, and 55 (77%) of enrollees ultimately received the treatment.
Subjects had to have Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, and morphological disease in the bone marrow (>5% blasts). After leukapheresis and conditioning chemotherapy, patients received a single brexucabtagene autoleucel infusion (1 × 106 CAR T cells per kg bodyweight).
At the median follow-up of 16.4 months (13.8-19.6), 39 patients (71%; 95% CI, 57-82, P < 0.0001) had complete remission (CR) or CR with incomplete hematological recovery. The median duration of remission (DOR) was 12.8 months (95% CI, 8.7-not estimable), and median relapse-free survival (RFS) was 11.6 months (2.7-15.5).
Ten (18%) patients received allo-SCT after brexucabtagene autoleucel infusion. One quarter of the subjects (14) had infections of grade 3 or higher. Two grade 5 brexucabtagene autoleucel-related events occurred (brain herniation and septic shock). Cytokine release syndrome (CRS) of grade 3 or higher occurred in 13 (24%) patients and neurological events of grade 3 or higher occurred in 14 (25%) patients.
