Table 3:
Safety outcomes by ZUMA-1 eligibility
| Measure (%) | Ineligible for ZUMA-1 N = 739 |
Eligible for ZUMA-1 or Unknown N = 558 |
Overall N = 1297 |
|---|---|---|---|
| CRS | |||
| Any grade | 612 (83) | 461 (83) | 1073 (83) |
| ≥ grade 3a | 73 (10) | 34 (6) | 107 (8) |
| Grade 4a | 38 (5) | 15 (3) | 53 (4) |
| Grade 5a | 14 (2) | 8 (1) | 22 (2) |
| Median time to onset (range), daysb | 4 (1-25) | 4 (1-28) | 4 (1-28) |
| Median duration (range), daysb | 7 (1-121) | 6 (1-81) | 6 (1-121) |
| Resolution rate by Day 21 since onset (95% CI)b | 91.1 (88.5-93.1) | 93.7 (91.0-95.6) | 92.2 (90.4-93.6) |
| ICANS | |||
| Any grade | 425 (58) | 289 (52) | 714 (55) |
| ≥ grade 3a | 193 (26) | 120 (22) | 313 (24) |
| Grade 4a | 73 (10) | 41 (7) | 114 (9) |
| Grade 5a | 8 (1) | 5 (< 1) | 13 (1) |
| Median time to onset (range), daysc | 7 (1-36) | 7 (1-25) | 7 (1-36) |
| Median duration (range), daysc | 7 (1-115) | 7 (1-112) | 7 (1-115) |
| Resolution rate by Day 21 since onset (95% CI)c | 75.4 (70.9-79.3) | 78.6 (73.5-82.9) | 76.7 (73.4-79.7) |
| Treatment for CRS or ICANS | |||
| Tocilizumab without corticosteroids | 122 (17) | 97 (17) | 219 (17) |
| Corticosteroids without tocilizumab | 56 (8) | 40 (7) | 96 (7) |
| Both tocilizumab and corticosteroids | 297 (40) | 235 (42) | 532 (41) |
| Prolonged cytopeniad | 195 (28) | 100 (18) | 295 (24) |
| Neutropenia | 45 (6) | 37 (7) | 82 (7) |
| Thrombocytopenia | 182 (26) | 89 (16) | 271 (22) |
| Clinically significant infection | 374 (51) | 206 (37) | 580 (45) |
| Subsequent neoplasms | 36 (5) | 14 (3) | 50 (4) |
Abbreviations: ASTCT, American Society of Transplant and Cellular Therapy; CI, confidence interval; CRS, cytokine release syndrome; ICANS, immune effector cell-associated neurotoxicity syndrome
a
Lee criteria for CRS grade; ASTCT consensus criteria for ICANS grade
b
Among patients with CRS (n = 1073)
c
Among patients with ICANS (n = 714)
d
Among patients alive at Day 30 post-infusion (n = 1238)