AEs occurring after the 18-month analysis among treated patients
n (%) . | FL (n = 124) . | MZL (n = 28) . | All patients (N = 152) . | |||
---|---|---|---|---|---|---|
Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | |
Any AE | 20 (16) | 10 (8) | 10 (36) | 7 (25) | 30 (20) | 17 (11) |
Serious AEs | 11 (9) | 10 (8) | 4 (14) | 3 (11) | 15 (10) | 13 (9) |
Cytopenias | 3 (2) | 2 (2) | 5 (18) | 5 (18) | 8 (5) | 7 (5) |
CRS | 0 | 0 | 3 (11) | 0 | 3 (2) | 0 |
Neurologic events | 0 | 0 | 1 (4) | 1 (4) | 1 (1) | 1 (1) |
Infections | 14 (11) | 6 (5) | 7 (25) | 2 (7) | 21 (14) | 8 (5) |
Hypogammaglobulinemia | 1 (1) | 0 | 1 (4) | 0 | 2 (1) | 0 |
Tumor lysis syndrome | 0 | 0 | 0 | 0 | 0 | 0 |
n (%) . | FL (n = 124) . | MZL (n = 28) . | All patients (N = 152) . | |||
---|---|---|---|---|---|---|
Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | |
Any AE | 20 (16) | 10 (8) | 10 (36) | 7 (25) | 30 (20) | 17 (11) |
Serious AEs | 11 (9) | 10 (8) | 4 (14) | 3 (11) | 15 (10) | 13 (9) |
Cytopenias | 3 (2) | 2 (2) | 5 (18) | 5 (18) | 8 (5) | 7 (5) |
CRS | 0 | 0 | 3 (11) | 0 | 3 (2) | 0 |
Neurologic events | 0 | 0 | 1 (4) | 1 (4) | 1 (1) | 1 (1) |
Infections | 14 (11) | 6 (5) | 7 (25) | 2 (7) | 21 (14) | 8 (5) |
Hypogammaglobulinemia | 1 (1) | 0 | 1 (4) | 0 | 2 (1) | 0 |
Tumor lysis syndrome | 0 | 0 | 0 | 0 | 0 | 0 |
CRS, cytokine release syndrome. AEs of interest were reported up to 24 months after axi-cel infusion. Serious AEs related to axi-cel that occurred after the data cutoff for the 18-month analysis (14 September 2020) occurred in 6 patients: 1 with COVID-19 and COVID-19 pneumonia, 1 with pyrexia, 1 with cellulitis, 1 with myelodysplastic syndrome, 1 with febrile neutropenia, and 1 with pneumonia.9