Table 3.
Summary of cytokine release syndrome and neurological events in pooled Phase 1 and 2 patients treated at pivotal dose (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) |
|
| Cytokine release syndrome, n (%)* | 14 (93) | 58 (92) | 34 (89) | 38 (95) | 16 (94) | 56 (92) | 26 (90) | 46 (94) |
| Grade 1 | 5 (33) | 10 (16) | 4 (11) | 11 (28) | 3 (18) | 12 (20) | 6 (21) | 9 (18) |
| Grade 2 | 7 (47) | 30 (48) | 18 (47) | 19 (48) | 7 (41) | 30 (49) | 15 (52) | 22 (45) |
| Grade ≥3 | 2 (13) | 18 (29) | 12 (32) | 8 (20) | 6 (35) | 14 (23) | 5 (17) | 15 (31) |
| Neurological events, n (%)† | 11 (73) | 42 (67) | 24 (63) | 29 (73) | 13 (76) | 40 (66) | 18 (62) | 35 (71) |
| Grade 1 | 3 (20) | 6 (10) | 4 (11) | 5 (13) | 4 (24) | 5 (8) | 2 (7) | 7 (14) |
| Grade 2 | 2 (13) | 17 (27) | 11 (29) | 8 (20) | 3 (18) | 16 (26) | 8 (28) | 11 (22) |
| Grade ≥3 | 6 (40) | 19 (30) | 9 (24) | 16 (40) | 6 (35) | 19 (31) | 8 (28) | 17 (35) |