Table 4:
Summary of Late Events after CD19 targeted CAR-T cells
| Late adverse events* | Entire cohort (N=86) | Ongoing CR (N=21) | Non-ongoing CR (N=65) | p-value** |
|---|---|---|---|---|
| Cytopenias (evaluated only in patients with ongoing CR and no diagnosis of subsequent MDS) | - | 3/ 19 (16%) | - | - |
| Hypogammaglobulinemia (% of patients with available data) | 28/42 (67%) | 14/19 (74%) | 14/ 23 (61%) | 0.51 |
| Infection density; mean number of infections/100 days at risk (Number of patients evaluated) | 0.57 (53) | 0.57 (20) | 0.58 (33) | 0.58† |
| Subsequent malignancies (%) | 0.08 | |||
| - All subsequent malignancies | 13 (15%) | 6 (29%) | 7 (11%) | |
| - MDS | 4 (5%) | 2 (10%) | 2 (3%) | 0.25 |
| - non-melanoma skin cancer | 6 (7%) | 2 (10%) | 4 (6%) | 0.63 |
| Immune-related events (%) | 7 (8%) | 2 (10%) | 5 (8%) | 1.00 |
| Neurologic events (%) | 9 (10%) | 2 (10%) | 7 (11%) | 1.00 |
| Patients with CVA/TIA | 4 (5%) | 0 (0%) | 4 (5%) | 0.57 |
| Psychiatric events (%) | 8 (9%) | 2 (10%) | 6 (9%) | 1.00 |
| GVHD (% of patients with prior allogeneic HCT) | 3/15 (20%) | 3/8 (38%) | 0/7 (0%) | 0.20 |
Number of patients with late adverse evens
Ongoing CR versus non-ongoing CR. P-values calculated using Fisher’s exact test.
P-value calculated using t-test from 100 bootstrap samples