Table 4.
Summary of patient incidence of treatment-emergent adverse events from R/R B-cell precursor ALL studies
| Adults | Pediatrics | |||||
|---|---|---|---|---|---|---|
| Blinatumomab pooled eventsa [20] | Blinatumomab TOWER [13] | SOC TOWER [13] | Blinatumomab ALCANTARA [22] | Blinatumomab MT103-205 [42] | ||
| N = 225 | N = 267 | N = 109 | N = 45 | N = 93 (Total) | N = 70 (5/15 µg/m2/day) | |
| All treatment-emergent adverse events, n (%) | 224 (100) | 263 (99) | 108 (99) | 45 (100) | 93 (100) | 70 (100.0) |
| Grade ≥ 3 | 182 (81) | 231 (87) | 100 (92) | 37 (82) | 83 (89) | 61 (87.1) |
| Serious | 146 (65) | 165 (62) | 49 (45) | 28 (62) | 54 (58) | 39 (55.7) |
| Fatal | 34 (15) | 51 (19) | 19 (17) | 5 (11) | 13 (14) | 8 (11.4) |
| Leading to study drug discontinuation | 44 (20) | 33 (12) | 9 (8) | 3 (7) | 10 (11) | 4 (5.7) |
| Leading to study drug interruption | 75 (33) | 86 (32) | 6 (6) | 16 (36) | 14 (15) | 10 (14.3) |
| Treatment–related treatment–emergent adverse events, n (%) | 202 (90) | 214 (80) | 92 (84) | 41 (91) | 80 (86) | 59 (84.3) |
| Grade ≥ 3 | 128 (57) | 143 (54) | 78 (72) | 20 (44) | 56 (60) | 38 (54.3) |
| Serious | 86 (38) | 74 (28) | 34 (31) | 12 (27) | 23 (25) | 15 (21.4) |
| Fatal | 4 (2) | 8 (3) | 8 (7) | 1 (2) | 1 (1) | 0 (0.0) |
| Leading to study drug discontinuation | 23 (10) | 19 (7) | 8 (7) | 2 (4) | 7 (8) | 2 (2.9) |
| Leading to study drug interruption | 53 (24) | 58 (22) | 6 (6) | 12 (27) | NA | NA |
Severity graded using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0/4.03
ALL acute lymphoblastic leukemia, NA not applicable, R/R relapsed/refractory
aTreatment-emergent adverse events pooled from studies MT103-206 and MT103-211