Table 1.
Patients and clinical covariates of 261 patients with relapsed/refractory large B-cell lymphoma
| Characteristic | All patients [N = 261] |
|---|---|
| Age at baseline, years [median (range)] | 63 (18–86) |
| Body weight at baseline, kg [median (range)] | 76.1 (40.1–182) |
| Body mass index at baseline, kg/m2 [median (range)] | 25.6 (16.8–51.6) |
| Creatinine clearance at baseline, mL/mina [median (range)] | 92.2 (24.7–351) |
| Aspartate aminotransferase at baseline, U/L [median (range)] | 22 (9–133) |
| Alanine aminotransferase at baseline, U/L [median (range)] | 17 (3–157) |
| Lactate dehydrogenase before LDC, U/L [median (range)] | 269 (112–11,900) |
| SPD (per IRC) before LDC, cm2 [median (range)] | 22.5 (0.8–419) |
| C-reactive protein at baseline, mg/L [median (range)] | 27.3 (0.25–2160) |
| Total administered dose, 106 cells [median (range)] | 91.1 (43.9–156) |
| Sex [n (%)] | |
|
Male Female |
168 (64) 93 (36) |
| Race [n (%)] | |
|
Caucasian African American Asian Others Multiple Unknown |
224 (86) 12 (5) 11 (4) 2 (1) 1 (0.4) 11 (4) |
| Ethnicity [n (%)] | |
|
Hispanic/Latino Non-Hispanic/Latino Unknown |
26 (10) 226 (87) 9 (3) |
| LVEF [n (%)] | |
|
≥ 40% and < 50% ≥ 50% |
12 (5) 249 (95) |
| Large B-cell lymphoma subtypes [n (%)] | |
|
DLBCL NOS DLBCL transformed from FL DLBCL transformed from other iNHL subtypes HGBCL PMBCL FL grade 3B |
135 (52) 59 (23) 15 (6) 35 (13) 15 (6) 2 (1) |
| ECOG PS at screening [n (%)] | |
|
0 1 2 |
107 (41) 150 (57) 4 (2) |
| Prior lines of systemic therapy [n (%)] | |
|
1 2 3 ≥ 4 |
8 (3) 120 (46) 67 (26) 66 (25) |
| Response to prior therapy [n (%)] | |
|
Refractory Relapsed |
206 (79) 55 (21) |
| Chemotherapy response [n (%)] | |
|
Refractory Sensitive |
174 (67) 87 (33) |
| Prior HSCTb [n (%)] | |
|
Yes No |
92 (35) 169 (65) |
| Never achieved CR with prior therapy [n (%)] | |
|
Yes No |
115 (44) 146 (56) |
| Secondary CNS lymphoma [n (%)] | |
|
Yes No |
7 (3) 254 (97) |
| Bridging therapy [n (%)] | |
|
Yes No |
154 (59) 107 (41) |
| Tocilizumab/corticosteroid use for CRS and/or NE treatment [n (%)] | |
|
Either or both Neither |
73 (28) 188 (72) |
| Liso-cel single-dose level [n (%)] | |
|
Dose level 1 Dose level 2 Dose level 3 |
44 (17) 176 (67) 41 (16) |
CNS central nervous system, CR complete response, CRS cytokine release syndrome, DLBCL diffuse large B-cell lymphoma, ECOG PS Eastern Cooperative Oncology Group performance status, FL follicular lymphoma, HGBCL high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, HSCT hematopoietic stem cell transplantation, iNHL indolent non-Hodgkin lymphoma, IRC Independent Review Committee, LDC lymphodepleting chemotherapy, LVEF left ventricular ejection fraction, NE neurological event, NOS not otherwise specified, PMBCL primary mediastinal B-cell lymphoma, SPD sum of the product of perpendicular diameters
aCalculated using the Cockcroft–Gault equation
bIncludes any prior autologous or allogeneic HSCT