Patient demographics and characteristics of liso-cel administration by AE (N = 127)
| AE stratification . | CRS only (n = 47)* . | NE only (n = 14)* . | Nonconcurrent CRS and NE (n = 21)* . | Concurrent CRS and NE (n = 45)* . | Any CRS and/or NE (n = 127) . | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Grade 1 . | Grade 2 . | Grade ≥3 . | Grade 1 . | Grade 2 . | Grade ≥3 . | Grade ≤2 CRS and NE . | Grade ≥3 CRS or NE . | Grade ≤2 CRS and NE . | Grade ≥3 CRS or NE . | Grade ≥3 CRS and NE . | ||
| Total, n (%)† | 33 (26.0) | 13 (10.2) | 1 (0.8) | 4 (3.1) | 3 (2.4) | 7 (5.5) | 16 (12.6) | 5 (3.9) | 29 (22.8) | 12 (9.4) | 4 (3.1) | 127 (100.0) |
| Age, y | ||||||||||||
| Mean (SD) | 56.3 (14.2) | 58.8 (13.6) | 47 (NA) | 60.8 (10.2) | 63.3 (8.1) | 62.3 (21.0) | 57.4 (11.2) | 57.6 (15.3) | 62.7 (14.3) | 60.4 (16.5) | 43.0 (23) | 58.8 (14.6) |
| Median | 58 | 63 | 47 | 64 | 62 | 66 | 58 | 58 | 64 | 64.5 | 45.5 | 62 |
| Range | 27-81 | 26-74 | NA | 46-69 | 56-72 | 19-82 | 33-74 | 33-73 | 29-86 | 37-79 | 18-63 | 18-86 |
| Male sex, n (%)‡ | 19 (57.6) | 10 (76.9) | 1 (100.0) | 3 (75.0) | 3 (100.0) | 5 (71.4) | 9 (56.3) | 4 (80.0) | 18 (62.1) | 7 (58.3) | 4 (100.0) | 83 (65.4) |
| White race, n (%)‡ | 27 (81.8) | 11 (84.6) | 1 (100.0) | 4 (100.0) | 3 (100.0) | 4 (57.1) | 15 (93.8) | 5 (100.0) | 28 (96.6) | 9 (75.0) | 4 (100.0) | 111 (87.4) |
| Non-Hispanic/non-Latino ethnicity, n (%)‡ | 29 (87.9) | 11 (84.6) | 1 (100.0) | 3 (75.0) | 3 (100.0) | 7 (100.0) | 14 (87.5) | 5 (100.0) | 25 (86.2) | 11 (91.7) | 2 (50.0) | 111 (87.4) |
| Site of administration, n (%)†‡ | ||||||||||||
| Inpatient | 30 (90.9) | 12 (92.3) | 1 (100.0) | 2 (50.0) | 3 (100.0) | 6 (85.7) | 13 (81.3) | 5 (100.0) | 25 (86.2) | 12 (100.0) | 3 (75.0) | 112 (88.2) |
| Outpatient | 3 (9.1) | 1 (7.7) | 0 | 2 (50.0) | 0 | 1 (14.3) | 3 (18.8) | 0 | 4 (13.8) | 0 | 1 (25.0) | 15 (11.8) |
| AE stratification . | CRS only (n = 47)* . | NE only (n = 14)* . | Nonconcurrent CRS and NE (n = 21)* . | Concurrent CRS and NE (n = 45)* . | Any CRS and/or NE (n = 127) . | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Grade 1 . | Grade 2 . | Grade ≥3 . | Grade 1 . | Grade 2 . | Grade ≥3 . | Grade ≤2 CRS and NE . | Grade ≥3 CRS or NE . | Grade ≤2 CRS and NE . | Grade ≥3 CRS or NE . | Grade ≥3 CRS and NE . | ||
| Total, n (%)† | 33 (26.0) | 13 (10.2) | 1 (0.8) | 4 (3.1) | 3 (2.4) | 7 (5.5) | 16 (12.6) | 5 (3.9) | 29 (22.8) | 12 (9.4) | 4 (3.1) | 127 (100.0) |
| Age, y | ||||||||||||
| Mean (SD) | 56.3 (14.2) | 58.8 (13.6) | 47 (NA) | 60.8 (10.2) | 63.3 (8.1) | 62.3 (21.0) | 57.4 (11.2) | 57.6 (15.3) | 62.7 (14.3) | 60.4 (16.5) | 43.0 (23) | 58.8 (14.6) |
| Median | 58 | 63 | 47 | 64 | 62 | 66 | 58 | 58 | 64 | 64.5 | 45.5 | 62 |
| Range | 27-81 | 26-74 | NA | 46-69 | 56-72 | 19-82 | 33-74 | 33-73 | 29-86 | 37-79 | 18-63 | 18-86 |
| Male sex, n (%)‡ | 19 (57.6) | 10 (76.9) | 1 (100.0) | 3 (75.0) | 3 (100.0) | 5 (71.4) | 9 (56.3) | 4 (80.0) | 18 (62.1) | 7 (58.3) | 4 (100.0) | 83 (65.4) |
| White race, n (%)‡ | 27 (81.8) | 11 (84.6) | 1 (100.0) | 4 (100.0) | 3 (100.0) | 4 (57.1) | 15 (93.8) | 5 (100.0) | 28 (96.6) | 9 (75.0) | 4 (100.0) | 111 (87.4) |
| Non-Hispanic/non-Latino ethnicity, n (%)‡ | 29 (87.9) | 11 (84.6) | 1 (100.0) | 3 (75.0) | 3 (100.0) | 7 (100.0) | 14 (87.5) | 5 (100.0) | 25 (86.2) | 11 (91.7) | 2 (50.0) | 111 (87.4) |
| Site of administration, n (%)†‡ | ||||||||||||
| Inpatient | 30 (90.9) | 12 (92.3) | 1 (100.0) | 2 (50.0) | 3 (100.0) | 6 (85.7) | 13 (81.3) | 5 (100.0) | 25 (86.2) | 12 (100.0) | 3 (75.0) | 112 (88.2) |
| Outpatient | 3 (9.1) | 1 (7.7) | 0 | 2 (50.0) | 0 | 1 (14.3) | 3 (18.8) | 0 | 4 (13.8) | 0 | 1 (25.0) | 15 (11.8) |
Table includes all patients who experienced ≥1 CRS or NE episode (n = 127).
NA, not applicable; SD, standard deviation.
Lee et al12 criteria were used to determine CRS toxicity grade, and National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.03)17 were used to determine NE toxicity grade.
Percentages based on patients who experienced a CRS and/or NE episode.
Percentages calculated within each column as percentage of AE type and severity.