TABLE 4.
Selected safety outcomes in trials of CD19‐targeted CAR‐T cell therapy in NHL
| ZUMA‐1 4 , 5 (N = 108) | JULIET 2 (N = 111) | TRANSCEND 6 (N = 269) | |
|---|---|---|---|
| Treatment of CRS and/or NE, % | |||
| Tocilizumab | 43 | 14 | 20 |
| Corticosteroids | 27 | 10 a | 21 |
| Admitted to intensive care unit | – | 24 | 4 |
| Prolonged cytopenias, b % | |||
| Any cytopenia (grade ≥ 3), ≥28 days | 38 | 32 | 37 |
| Neutropenia (grade ≥ 3), ≥28 days | 26 | 24 | 60 |
| Neutropenia (grade ≥ 3), ≥3 months | 11 | 0 | – |
| Anemia (grade ≥ 3), ≥28 days | 10 | – | 37 |
| Anemia (grade ≥ 3), ≥3 months | 3 | – | – |
| Thrombocytopenia (grade ≥ 3), ≥28 days | 24 | 41 | 27 |
| Thrombocytopenia (grade ≥ 3), ≥3 months | 7 | 38 | – |
| Infections (grade ≥ 3), % | 28 | 20 | 12 |
| Tumor lysis syndrome (grade ≥ 3), % | 1 | 1 | 1 |
| Hypogammaglobulinemia (grade ≥ 3), % | 0 | – | 0 |
| Treatment‐related mortality, % | 2 c | 0 | 1 d |
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: CAR, chimeric antigen receptor; CD, cluster of differentiation; CRS, cytokine release cyndrome; HLH, hemophagocytic lymphohistiocytosis; NE, neurological events; NHL, non‐Hodgkin lymphoma.
− refers to not reported or known values.
a
Corticosteroids and tocilizumab.
b
Not resolved by study day 30 for ZUMA‐1, day 28 for JULIET, and day 29 for TRANSCEND.
c
One patient died with HLH and one patient died of cardiac arrest in the setting of CRS.
d
One patient died of diffuse alveolar damage that was related to liso‐cel treatment.