Baseline patient and disease characteristics
| Characteristic . | Tisa-cel (n = 50) . | Brexu-cel (n = 20) . | P value . |
|---|---|---|---|
| Sex, n (%) | .35 | ||
| M | 29 (58) | 14 (70) | |
| F | 21 (42) | 6 (30) | |
| Age at CAR T-cell infusion, median (range), y | 21 (18-26) | 22.5 (18-26) | |
| Race/ethnicity, n (%) | .81 | ||
| Non-Hispanic White | 24 (48) | 9 (45) | |
| Hispanic | 19 (38) | 8 (40) | |
| Black | 2 (4) | 0 | |
| Asian/Pacific Islander | 0 | 2 (10) | |
| Other/not reported | 5 (10) | 1 (5) | |
| ALL subtype, n (%) | .8 | ||
| Ph– ALL∗ | 33 (66) | 12 (60) | |
| Ph+ ALL | 5 (10) | 3 (15) | |
| Ph-like ALL | 11 (22) | 5 (25) | |
| Unknown | 1 (2) | 0 | |
| Marrow disease before CAR T, n (%) | .1 | ||
| Undetectable MRD | 15 (30) | 3 (15) | |
| Detectable MRD with <5% blasts† | 12 (24) | 11 (55) | |
| Flow cytometry | 12 | 6 | |
| clonoSEQ | 0 | 3 | |
| qPCR | 0 | 1 | |
| NGS | 0 | 0 | |
| 5 to <50% blasts | 9 (18) | 2 (10) | |
| >50% blasts | 11 (22) | 3 (15) | |
| Unknown | 3 (6) | 1 (5) | |
| Extramedullary disease before CAR T, n (%) | .11 | ||
| Present | 5 (10) | 5 (25) | |
| Not present | 45 (90) | 3 (15) | |
| Not assessed/unknown | 0 | 12 (60) | |
| CNS disease status before CAR T, n (%) | .11 | ||
| CNS 1 | 41 (82) | 11 (55) | |
| CNS 2 | 1 (2) | 1 (5) | |
| CNS 3 | 2 (4) | 1 (5) | |
| Not assessed/unknown | 6 (12) | 7 (35) | |
| Therapy before CAR T | |||
| Total lines of therapy, median (range) | 3 (1-5) | 3 (1-9) | |
| Blinatumomab, n (%)‡ | 12 (24) | 9 (45) | .08 |
| Inotuzumab, n (%)‡ | 13 (26) | 6 (30) | .73 |
| Allogeneic HCT, n (%) | 20 (40) | 3 (15) | .04 |
| Bridging therapy between apheresis and lymphodepletion, n (%) | 26 (52) | 15 (75) | .08 |
| Lymphodepletion regimen, n (%) | .22 | ||
| Fludarabine/cyclophosphamide | 47 (94) | 17 (85) | |
| Other | 3 (6) | 3 (15) |
| Characteristic . | Tisa-cel (n = 50) . | Brexu-cel (n = 20) . | P value . |
|---|---|---|---|
| Sex, n (%) | .35 | ||
| M | 29 (58) | 14 (70) | |
| F | 21 (42) | 6 (30) | |
| Age at CAR T-cell infusion, median (range), y | 21 (18-26) | 22.5 (18-26) | |
| Race/ethnicity, n (%) | .81 | ||
| Non-Hispanic White | 24 (48) | 9 (45) | |
| Hispanic | 19 (38) | 8 (40) | |
| Black | 2 (4) | 0 | |
| Asian/Pacific Islander | 0 | 2 (10) | |
| Other/not reported | 5 (10) | 1 (5) | |
| ALL subtype, n (%) | .8 | ||
| Ph– ALL∗ | 33 (66) | 12 (60) | |
| Ph+ ALL | 5 (10) | 3 (15) | |
| Ph-like ALL | 11 (22) | 5 (25) | |
| Unknown | 1 (2) | 0 | |
| Marrow disease before CAR T, n (%) | .1 | ||
| Undetectable MRD | 15 (30) | 3 (15) | |
| Detectable MRD with <5% blasts† | 12 (24) | 11 (55) | |
| Flow cytometry | 12 | 6 | |
| clonoSEQ | 0 | 3 | |
| qPCR | 0 | 1 | |
| NGS | 0 | 0 | |
| 5 to <50% blasts | 9 (18) | 2 (10) | |
| >50% blasts | 11 (22) | 3 (15) | |
| Unknown | 3 (6) | 1 (5) | |
| Extramedullary disease before CAR T, n (%) | .11 | ||
| Present | 5 (10) | 5 (25) | |
| Not present | 45 (90) | 3 (15) | |
| Not assessed/unknown | 0 | 12 (60) | |
| CNS disease status before CAR T, n (%) | .11 | ||
| CNS 1 | 41 (82) | 11 (55) | |
| CNS 2 | 1 (2) | 1 (5) | |
| CNS 3 | 2 (4) | 1 (5) | |
| Not assessed/unknown | 6 (12) | 7 (35) | |
| Therapy before CAR T | |||
| Total lines of therapy, median (range) | 3 (1-5) | 3 (1-9) | |
| Blinatumomab, n (%)‡ | 12 (24) | 9 (45) | .08 |
| Inotuzumab, n (%)‡ | 13 (26) | 6 (30) | .73 |
| Allogeneic HCT, n (%) | 20 (40) | 3 (15) | .04 |
| Bridging therapy between apheresis and lymphodepletion, n (%) | 26 (52) | 15 (75) | .08 |
| Lymphodepletion regimen, n (%) | .22 | ||
| Fludarabine/cyclophosphamide | 47 (94) | 17 (85) | |
| Other | 3 (6) | 3 (15) |
F, female; M, male; NGS, next-generation sequencing; qPCR, quantitative polymerase chain reaction.
Ph– ALL tisa-cel group includes 1 mixed-phenotype acute leukemia.
MRD methodology unknown in 1 patient with detectable MRD.
One patient in brexu-cel group received both blinatumomab and inotuzumab before CAR T.