Table 3.
Deaths by year
| n (%) | N = 101 |
||||||
|---|---|---|---|---|---|---|---|
| Total | Year 1 | Year 2 | Year 3 | Year 4 | Year 5 | Year >5 | |
| Patients who died | 59 (58) | 40 (40) | 10 (10) | 4 (4) | 3 (3) | 1 (1) | 1 (1) |
| Primary cause of death | |||||||
| Progressive disease∗ | 45 (45) | 32 (32) | 9 (9) | 3 (3) | 0 | 1 (1) | 0 |
| AE† | 4 (4) | 3 (3) | 1 (1) | 0 | 0 | 0 | 0 |
| Secondary malignancy | 1 (1) | 0 | 0 | 0 | 0 | 0 | 1 (1) |
| Other‡ | 9 (9) | 5 (5) | 0 | 1 (1) | 3 (3) | 0 | 0 |
MDS, myelodysplastic syndrome.
After year 2, 4 patients with DLBCL who had a best response of a CR later had progressive disease on days 99, 184, 266, and 546 after infusion, respectively. During ongoing safety monitoring after the data cutoff, 1 event of central nervous system lesion, which was not amenable to biopsy, was reported. Treatment for presumed progressive disease for DLBCL was initiated by the investigator.
Two events had no causal relationship (sepsis and pulmonary embolism), and 2 events were related to axi-cel (brain injury due to cardiac arrest, and hemophagocytic lymphohistiocytosis).
Events included infection (n = 3), cardiac arrest (n = 2), pulmonary nocardiosis (n = 1), sepsis (n = 1), complications of allogeneic transplantation for previous treatment–related MDS not related to axi-cel (n = 1), and unknown (n = 1).