Malignancies of T-cell origin after treatment with axi-cel or brexu-cel reported in the Gilead Global Safety Database
| . | Postauthorization setting . | Kite-sponsored clinical trial setting . | Gilead Global Safety Database total . |
|---|---|---|---|
| Patients treated with axi-cel, N | 16 623 | 905 | 17 578∗ |
| Reporting rate of patients with subsequent malignancies of T-cell origin, n (%)† | 12 (0.072) | 1 (0.110) | 13 (0.074) |
| MedDRA high-level group term‡ | |||
| Non-Hodgkin lymphomas of T-cell origin | 7 (0.042) | 0 | 7 (0.04) |
| Leukemias | 4 (0.024) | 1 (0.110) | 5 (0.028)§ |
| Hematopoietic neoplasm (excluding leukemias and lymphomas) | 2 (0.012) | 0 | 2 (0.011)§ |
| Patients treated with brexu-cel, N | 2940 | 396 | 3336 |
| Reported number of patients with subsequent malignancies of T-cell origin, n | 0 | 0 | 0 |
| . | Postauthorization setting . | Kite-sponsored clinical trial setting . | Gilead Global Safety Database total . |
|---|---|---|---|
| Patients treated with axi-cel, N | 16 623 | 905 | 17 578∗ |
| Reporting rate of patients with subsequent malignancies of T-cell origin, n (%)† | 12 (0.072) | 1 (0.110) | 13 (0.074) |
| MedDRA high-level group term‡ | |||
| Non-Hodgkin lymphomas of T-cell origin | 7 (0.042) | 0 | 7 (0.04) |
| Leukemias | 4 (0.024) | 1 (0.110) | 5 (0.028)§ |
| Hematopoietic neoplasm (excluding leukemias and lymphomas) | 2 (0.012) | 0 | 2 (0.011)§ |
| Patients treated with brexu-cel, N | 2940 | 396 | 3336 |
| Reported number of patients with subsequent malignancies of T-cell origin, n | 0 | 0 | 0 |
Cases reported cumulatively up to 5 March 2024.
MedDRA, Medical Dictionary for Regulatory Activities.
Includes 50 patients from a non–Kite-sponsored interventional clinical trial in China (not included in the Kite–sponsored clinical trial setting).
The percentage is derived from the number of patients reporting at least 1 event among the total treated with the CAR T-cell therapy in that setting.
The Gilead Global Safety Database was searched for events of subsequent malignancies of T-cell origin that matched 77 preferred terms from MedDRA version 26.1 (supplemental Methods).
In 1 case, the preferred terms lymphocytic leukemia and lymphoproliferative disorder were reported for the same condition.