Table 1.
Baseline disease and patient characteristics in pooled Phase 1 and 2 patients treated at the pivotal dose (N=78) by prior therapies
| Phase 1 and 2 treated patients (N=78)* | Prior number of therapies | Prior blinatumomab | Prior inotuzumab | Prior alloSCT | ||||||
| 1 (n=15) |
≥2 (n=63) |
Yes (n=38) |
No (n=40) |
Yes (n=17) |
No (n=61) |
Yes (n=29) |
No (n=49) |
|||
| Age, median (range), years | 42.5 (18–84) | 39 (21–65) | 44 (18–84) | 39 (18–84) | 44.5 (19-77) | 46 (18–84) | 39 (19–73) | 39 (19–69) | 45 (18–84) | |
| ≥65 years, n (%) | 12 (15) | 1 (7) | 11 (17) | 5 (13) | 7 (18) | 3 (18) | 9 (15) | 3 (10) | 9 (18) | |
| Male, n (%) | 42 (54) | 9 (60) | 33 (52) | 21 (55) | 21 (53) | 12 (71) | 30 (49) | 15 (52) | 27 (55) | |
| ECOG PS of 1, n (%) | 56 (72) | 9 (60) | 47 (75) | 28 (74) | 28 (70) | 13 (76) | 43 (70) | 21 (72) | 35 (71) | |
| Philadelphia chromosome-positive, n (%) | 17 (22) | 2 (13) | 15 (24) | 5 (13) | 12 (30) | 4 (24) | 13 (21) | 10 (34) | 7 (14) | |
| Extramedullary disease at screening, n (%) | 9 (12) | 0 | 9 (14) | 7 (18) | 2 (5) | 2 (12) | 7 (11) | 3 (10) | 6 (12) | |
| CNS-1 disease at baseline, n (%) | 78 (100) | 15 (100) | 63 (100) | 38 (100) | 40 (100) | 17 (100) | 61 (100) | 29 (100) | 49 (100) | |
| Bone marrow blasts at baseline, median (range) % | 63 (0–98) | 58 (0–95) | 65 (2–98) | 70 (2–98) | 54 (0–96) | 76 (2–98) | 52 (0–97) | 61 (0–96) | 65 (0–98) | |
| >25%, n (%) | 56 (72) | 10 (67) | 46 (73) | 28 (74) | 28 (70) | 14 (82) | 42 (69) | 20 (69) | 36 (73) | |
| CD19 lymphoblast baseline category per central laboratory, % | ||||||||||
| ≥95 | 58 (74) | 11 (73) | 47 (75) | 29 (76) | 29 (73) | 13 (76) | 45 (74) | 21 (72) | 37 (76) | |
| <95 | 15 (19) | 3 (20) | 12 (19) | 7 (18) | 8 (20) | 4 (24) | 11 (18) | 6 (21) | 9 (18) | |
| Missing | 5 (6) | 1 (7) | 4 (6) | 2 (5) | 3 (8) | 0 | 5 (8) | 2 (7) | 3 (6) | |
| Number of prior therapies, median (range) | 2 (1–8) | 1 (1–1) | 3 (2–8) | 3 (1–8) | 2 (1–5) | 3 (2–7) | 2 (1–8) | 3 (1–8) | 2 (1–7) | |
| ≥3 prior lines of therapy, n (%) | 37 (47) | 0 | 37 (59) | 22 (58) | 15 (38) | 14 (82) | 23 (38) | 19 (66) | 18 (37) | |
| Prior blinatumomab, n (%) | 38 (49) | 1 (7) | 37 (59) | 38 (100) | 0 | 10 (59) | 28 (46) | 14 (48) | 24 (49) | |
| Prior inotuzumab, n (%) | 17 (22) | 0 | 17 (27) | 10 (26) | 7 (18) | 17 (100) | 0 | 5 (17) | 12 (24) | |
| Prior alloSCT, n (%) | 29 (37) | 2 (13) | 27 (43) | 14 (37) | 15 (38) | 5 (29) | 24 (39) | 29 (100) | 0 | |
| Prior radiotherapy, n (%) | 19 (24) | 3 (20) | 16 (25) | 11 (29) | 8 (20) | 3 (18) | 16 (26) | 14 (48) | 5 (10) | |
| Primary refractory, n (%) | 24 (31) | 6 (40) | 18 (29) | 11 (29) | 13 (33) | 4 (24) | 20 (33) | 7 (24) | 17 (35) | |
| Relapsed or refractory to second or greater line of therapy, n (%) | 60 (77)† | 0 | 60 (95) | 35 (92) | 25 (63) | 17 (100) | 43 (70) | 25 (86) | 35 (71) | |
| First relapse with remission ≤12.0 months, n (%) | 22 (28) | 8 (53) | 14 (22) | 7 (18) | 15 (38) | 0 | 22 (36) | 7 (24) | 15 (31) | |
| Relapsed or refractory post-alloSCT, n (%) | 30 (38)‡ | 3 (20) | 27 (43) | 14 (37) | 16 (40) | 5 (29) | 25 (41) | 29 (100) | 1 (2)‡ | |
| Response to the last prior therapy, n (%) | ||||||||||
| CR | 25 (32) | 8 (53) | 17 (27) | 11 (29) | 14 (35) | 3 (18) | 22 (36) | 12 (41) | 13 (27) | |
| CRi | 2 (3) | 1 (7) | 1 (2) | 0 | 2 (5) | 0 | 2 (3) | 1 (3) | 1 (2) | |
| PR | 2 (3) | 0 | 2 (3) | 1 (3) | 1 (3) | 0 | 2 (3) | 1 (3) | 1 (2) | |
| NR | 24 (31) | 3 (20) | 21 (33) | 10 (26) | 14 (35) | 5 (29) | 19 (31) | 4 (14) | 20 (41) | |
| PD | 19 (24) | 3 (20) | 16 (25) | 13 (34) | 6 (15) | 5 (29) | 14 (23) | 6 (21) | 13 (27) | |
| Not evaluated | 6 (8) | 0 | 6 (10) | 3 (8) | 3 (8) | 4 (24) | 2 (3) | 5 (17) | 1 (2) | |
*Only includes patients who received the pivotal dose of brexu-cel.
†Two patients with relapsed or refractory disease to second or greater lines of therapy were erroneously not marked in the eCRF as such.
‡One patient had prior autologous transplantation but was erroneously marked in the eCRF as relapsed/refractory disease after alloSCT.
alloSCT, allogeneic stem cell transplantation; CNS, central nervous system; CR, complete remission; CRi, complete remission with incomplete hematological recovery; ECOG PS, Eastern Cooperative Oncology Group performance status; eCRF, electronic case report form; NR, no response; PD, progressive disease; PR, partial response.