TABLE 6.
Safety of commercial CAR‐T cell therapy in the real‐world setting [Correction added on August 27, 2021, after first online publication: In the heading of Table 6, the horizontal bars under Axicabtagene ciloleucel and Tisagenlecleucel were corrected in this version.]
| Axicabtagene ciloleucel | Tisagenlecleucel | ||||
|---|---|---|---|---|---|
| Nastoupil et al. 44 (N = 275) | Pasquini et al. 46 CIBMTR (N = 533) | Riedell et al. 20 (N = 158) | Riedell et al. 20 (N = 86) | Pasquini et al. 47 CIBMTR (N = 155) | |
| Any‐grade CRS, % | 91 a | ~82 a | 85 b | 41 b | 45 b |
| Grade ≥ 3 CRS | 7 | ~9 | 8 | 1 | 5 |
| Any‐grade neurological AEs, % | 69 c | 58 d | 53 e | 14 e | 18 d |
| Grade ≥ 3 neurological AEs | 31 | ~19 | 33 | 0 | 5 |
| Tocilizumab, % | 62 | – | 61 | 15 | 19 |
| Corticosteroids, % | 54 | – | 53 f | 8 f | 5 |
| Admitted to ICU, % | 33 | – | 39 | 7 | – |
| Treatment‐related mortality, n (%) | 2 (1) | 12 (2) | – | – | – |
Note: The purpose of this table is to summarize data. Head‐to‐head studies have not been performed and no comparisons can be made.
Abbreviations: AE, adverse event; ASTCT, American Society for Transplantation and Cellular Therapy; CAR, chimeric antigen receptor; CARTOX, CAR T cell‐therapy‐associated TOXicity; CIBMTR; Center for International Blood and Marrow Transplant Research; CRS, cytokine release syndrome; CTCAE, Common Terminology Criteria for Adverse Events; ICANS, immune‐effector cell associated encephalopathy‐associated neurotoxicity syndrome; ICU, intensive care unit.
‐ refers to not reported or known values.
Graded using the Lee criteria. 34
Graded using the ASTCT scale.
Graded using ICANS. 37
Graded according to CARTOX, ASTCT, and CTCAE.
Steroid use.