Table 2.
Summary of treatment-related AEs
| Patients, n (%)∗ | Arm 1 (lete-cel) (N = 3) | Arm 2 (lete-cel + pembrolizumab) (N = 3) | Total (N = 6) |
|---|---|---|---|
| Treatment-related AEs | 3 (100) | 3 (100) | 6 (100) |
| Lymphodepletion-related | 3 (100) | 3 (100) | 6 (100) |
| Lete-cel–related | 2 (67) | 3 (100) | 5 (83) |
| Treatment-related SAEs | 1 (33) | 1 (33) | 2 (33) |
| Lymphodepletion-related | 1 (33) | 1 (33) | 2 (33) |
| Lete-cel–related | 1 (33) | 1 (33) | 2 (33) |
| Treatment-related AE grade ≥3† | |||
| Leukopenia | 3 (100) | 3 (100) | 6 (100) |
| Lymphopenia | 3 (100) | 2 (67) | 5 (83) |
| Neutropenia | 3 (100) | 2 (67) | 5 (83) |
| Anemia | 2 (67) | 2 (67) | 4 (67) |
| Thrombocytopenia | 2 (67) | 2 (67) | 4 (67) |
| Pancytopenia | 1 (33) | 1 (33) | 2 (33) |
| Atrial fibrillation | 0 | 1 (33) | 1 (17) |
| Stomatitis | 0 | 1 (33) | 1 (17) |
Treatment-related AEs in the mITT population, including all patients who received lete-cel. Safety assessed per NCI-CTCAE version 4.0.26
mITT, modified ITT; N, patients in mITT population; n, patients with available data; SAEs, serious AEs.
Study treatment-related AEs includes those related to lymphodepletion or lete-cel infusion and are defined as AEs with definite, probable, and possible study drug relationship; AEs are listed in descending order of total frequency. No patients experienced a grade 5 AE.
Cytopenias were reported as pooled terms: anemia included anemia/red blood cell count decrease; leukopenia included leukopenia/white blood cell decrease; thrombocytopenia included thrombocytopenia/platelet count decrease; lymphopenia included lymphopenia/lymphocyte count decrease; and neutropenia included neutropenia/neutrophil count decrease.