TEAEs of special interest (safety set)
AEs of special interest of CRS or NEs . | Liso-cel (n = 92) . | |
---|---|---|
CRS, n (%)∗ | ||
Any grade | 45 (49) | |
Grade 1 | 34 (37) | |
Grade 2 | 10 (11) | |
Grade 3 | 1 (1) | |
Grade 4/5 | 0 | |
Median (range) time to onset, d | 5.0 (1-63) | |
Median (range) time to resolution, d | 4.0 (1-16) | |
NEs, n (%)† | ||
Any grade | 10 (11) | |
Grade 1 | 4 (4) | |
Grade 2 | 2 (2) | |
Grade 3 | 4 (4) | |
Grade 4/5 | 0 | |
Median (range) time to onset, d | 11.0 (7-17) | |
Median (range) time to resolution, d | 4.5 (1-30) | |
Clinical management of CRS and/or NEs, n (%) | ||
Tocilizumab, corticosteroids, or both | 24 (26) | |
Tocilizumab only | 9 (10) | |
Tocilizumab and corticosteroids | 13 (14) | |
Corticosteroids only | 2 (2) | |
Vasopressors | 0 |
AEs of special interest of CRS or NEs . | Liso-cel (n = 92) . | |
---|---|---|
CRS, n (%)∗ | ||
Any grade | 45 (49) | |
Grade 1 | 34 (37) | |
Grade 2 | 10 (11) | |
Grade 3 | 1 (1) | |
Grade 4/5 | 0 | |
Median (range) time to onset, d | 5.0 (1-63) | |
Median (range) time to resolution, d | 4.0 (1-16) | |
NEs, n (%)† | ||
Any grade | 10 (11) | |
Grade 1 | 4 (4) | |
Grade 2 | 2 (2) | |
Grade 3 | 4 (4) | |
Grade 4/5 | 0 | |
Median (range) time to onset, d | 11.0 (7-17) | |
Median (range) time to resolution, d | 4.5 (1-30) | |
Clinical management of CRS and/or NEs, n (%) | ||
Tocilizumab, corticosteroids, or both | 24 (26) | |
Tocilizumab only | 9 (10) | |
Tocilizumab and corticosteroids | 13 (14) | |
Corticosteroids only | 2 (2) | |
Vasopressors | 0 |
Other AEs of special interest . | Liso-cel (n = 92) . | SOC (n = 91) . |
---|---|---|
Severe infections, n (%) | 14 (15) | 19 (21) |
Hypogammaglobulinemia, n (%) | 10 (11) | 3 (3) |
Grade ≥3 cytopenia at study d 64, n (%)‡ | 40 (43) | 3 (3) |
Grade ≥3 neutropenia at study d 64‡ | 34 (37) | 2 (2) |
Recovered to grade ≤2 within 35 d§ | 25 (74) | 1 (100) |
Recovered to grade ≤2 within 62 d§ | 4 (12) | 0 |
Recovered to grade ≤2 by end of study§ | 4 (12) | 0 |
Grade ≥3 thrombocytopenia at study d 64‡ | 34 (37) | 0 |
Recovered to grade ≤2 within 35 d§ | 24 (73) | 0 |
Recovered to grade ≤2 within 62 d§ | 3 (9) | 0 |
Recovered to grade ≤2 by end of study§ | 1 (3) | 0 |
Grade ≥3 anemia at study d 64, n (%) | 11 (12) | 1 (1) |
Recovered to grade ≤2 within 35 d§ | 8 (73) | 1 (100) |
Recovered to grade ≤2 within 62 d§ | 2 (18) | 0 |
Recovered to grade ≤2 by end of study§ | 0 | 0 |
Other AEs of special interest . | Liso-cel (n = 92) . | SOC (n = 91) . |
---|---|---|
Severe infections, n (%) | 14 (15) | 19 (21) |
Hypogammaglobulinemia, n (%) | 10 (11) | 3 (3) |
Grade ≥3 cytopenia at study d 64, n (%)‡ | 40 (43) | 3 (3) |
Grade ≥3 neutropenia at study d 64‡ | 34 (37) | 2 (2) |
Recovered to grade ≤2 within 35 d§ | 25 (74) | 1 (100) |
Recovered to grade ≤2 within 62 d§ | 4 (12) | 0 |
Recovered to grade ≤2 by end of study§ | 4 (12) | 0 |
Grade ≥3 thrombocytopenia at study d 64‡ | 34 (37) | 0 |
Recovered to grade ≤2 within 35 d§ | 24 (73) | 0 |
Recovered to grade ≤2 within 62 d§ | 3 (9) | 0 |
Recovered to grade ≤2 by end of study§ | 1 (3) | 0 |
Grade ≥3 anemia at study d 64, n (%) | 11 (12) | 1 (1) |
Recovered to grade ≤2 within 35 d§ | 8 (73) | 1 (100) |
Recovered to grade ≤2 within 62 d§ | 2 (18) | 0 |
Recovered to grade ≤2 by end of study§ | 0 | 0 |
Graded per the Lee 2014 criteria.11
Defined as investigator-identified neurological AEs related to liso-cel and graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Defined as grade ≥3 central laboratory results at 35 days after liso-cel infusion or after the start of the last chemotherapy in the SOC arm. Prolonged cytopenia was assessed at the study day 64 visit for patients in the liso-cel arm (35 days after liso-cel infusion) or 35 days after the start of the last cycle of chemotherapy, including high-dose chemotherapy, for patients in the SOC arm. A window of ±6 days around these target dates was considered; within this window, the closest central laboratory assessment to the target date was used, and in case 2 assessments within the same window were equidistant from the target date, the worst result was taken. Laboratory assessments performed after starting a new antineoplastic therapy were not considered for analysis.
In the liso-cel arm, poststudy day 64 laboratory results were available for 34, 33, and 11 patients with grade ≥3 neutropenia, thrombocytopenia, and anemia, respectively. In the SOC arm, poststudy day 64 laboratory results were available for 1, 0, and 1 patient with grade ≥3 neutropenia, thrombocytopenia, and anemia, respectively. Recovery to grade ≤2 cytopenia was assessed on days 35 and 62 days after the initial prolonged cytopenia assessment and at the end of the study.