Table 4:
Adverse events of special interest and management of cytokine release syndrome and neurological events (safety set)
| Full population (n=117) | |
|---|---|
|
| |
| Patients with cytokine release syndrome | |
| Any grade | 99 (85%) |
| Grade 1 | 43 (37%) |
| Grade 2 | 46 (39%) |
| Grade 3 | 10 (9%) |
| Grade 4 | 0 |
| Grade 5 | 0 |
| Time to cytokine release syndrome onset, days* | 4 (1–7) |
| Time to cytokine release syndrome resolution, days* | 6 (4–11) |
| Patients with neurological events † | |
| Any grade | 53 (45%) |
| Grade 1 | 13 (11%) |
| Grade 2 | 18 (15%) |
| Grade 3 | 21 (18%) |
| Grade 4 | 1 (1%) |
| Grade 5 | 0 |
| Time to neurological event onset, days* | 7 (4–11) |
| Time to neurological event resolution, days* | 7 (4–16) |
| Tocilizumab and corticosteroid use for cytokine release syndrome | |
| Doses of tocilizumab (n=76) | 1 (1–2) |
| Tocilizumab only | 41 (35%) |
| Corticosteroids only | 2 (2%) |
| Both tocilizumab and corticosteroids | 35 (30%) |
| Tocilizumab or corticosteroids or both | 78 (67%) |
| Tocilizumab and corticosteroid use for neurological event | |
| Doses of tocilizumab (n=8) | 1 (1–1) |
| Tocilizumab only | 0 |
| Corticosteroids only | 31 (26%) |
| Both tocilizumab and corticosteroids | 8 (7%) |
| Tocilizumab or corticosteroids or both | 39 (33%) |
| Other adverse events of special interest | |
| Prolonged cytopenia‡ | 63 (54%) |
| Grade ≥3 infections§ | 20 (17%) |
| Hypogammaglobulinaemia¶ | 18 (15%) |
| Tumour lysis syndrome | 13 (11%) |
| Second primary malignancy|| | 11 (9%) |
| Macrophage activation syndrome** | 4 (3%) |
Data are n (%) or median (IQR). Liso-cel=lisocabtagene maraleucel.
Any event that stopped and started again within 7 days was considered a single episode; time to resolution was defined as the number of days from onset of the first event to when the last event of the first episode ended; patients with an unresolved episode were excluded.
Neurological events were defined as investigator-identified neurological adverse events related to liso-cel.
Defined as grade ≥3 laboratory abnormalities of one or more of neutropenia, anaemia, or thrombocytopenia at day 30 after liso-cel infusion.
Infection includes grade ≥3 treatment-emergent adverse events from the infections and infestations system organ class by adverse event high-level group term.
Based on adverse events only; adverse events from the 90-day treatment-emergent period, post-treatment-emergent period, and long-term follow-up were included; grade 3 hypogammaglobulinaemia occurred in three patients, with no grade 4 or 5 events during the study.
Based on adverse events only; adverse events from the 90-day treatment-emergent period, post-treatment-emergent period, and long-term follow-up were included.
Grade ≥3 macrophage activation syndrome events occurred in three patients (grade 3, n=1; grade 4, n=1; grade 5, n=1).