Demographics and disease characteristics
| . | Liso-cel–treated set (N = 270) . |
|---|---|
| Sex, n (%) | |
| Male | 174 (64) |
| Female | 96 (36) |
| Median age (range), y | 63 (18-86) |
| ≥65 y | 112 (41) |
| ≥75 y | 27 (10) |
| Ethnicity, n (%) | |
| Not Hispanic or Latino | 233 (86) |
| Hispanic or Latino | 27 (10) |
| Not reported | 10 (4) |
| Race, n (%) | |
| White | 233 (86) |
| Black or African American | 12 (4) |
| Asian | 11 (4) |
| American Indian or Alaska Native | 2 (<1) |
| Multiple | 1 (<1) |
| Not reported | 11 (4) |
| Non-Hodgkin lymphoma subtypes, n (%) | |
| Diffuse LBCL, not otherwise specified | 137 (51) |
| Diffuse LBCL transformed from indolent lymphoma | 78 (29) |
| Transformed from follicular lymphoma | 60 (22) |
| Transformed from other indolent non-Hodgkin lymphoma subtypes | 18 (7) |
| High-grade B-cell lymphoma with gene rearrangements in MYC and either BCL2, BCL6, or both | 36 (13) |
| Primary mediastinal B-cell lymphoma | 15 (6) |
| Follicular lymphoma grade 3B | 4 (1) |
| ECOG PS at screening, n (%) | |
| 0 | 111 (41) |
| 1 | 155 (57) |
| 2 | 4 (1) |
| Before lymphodepleting chemotherapy | |
| Median sum of the product of perpendicular diameters (range), cm2 | 22.5 (0.8-418.6) |
| Sum of the product of perpendicular diameters ≥50 cm2, n (%) | 73 (28) |
| Median lactate dehydrogenase (range), U/L | 264.5 (112-11 933) |
| Lactate dehydrogenase ≥500 U/L, n (%) | 58 (21) |
| Creatinine clearance <60 mL/min, n (%) | 51 (19) |
| Median baseline C-reactive protein (range), mg/L | 27.4 (0.25-2158.0) |
| Left ventricular ejection fraction ≥40% and <50%, n (%) | 13 (5) |
| Median previous lines of systemic therapy (range) | 3 (1-8) |
| Number of previous lines of systemic therapy,∗ n (%) | |
| 1 | 9 (3) |
| 2 | 122 (45) |
| 3 | 68 (25) |
| ≥4 | 71 (26) |
| Chemotherapy refractory,† n (%) | 181 (67) |
| Received previous HSCT, n (%) | 94 (35) |
| Autologous HSCT | 90 (33) |
| Allogeneic HSCT | 9 (3) |
| Never achieved CR with previous therapy, n (%) | 119 (44) |
| Secondary CNS lymphoma, n (%) | 7 (3) |
| Received bridging therapy, n (%) | 159 (59) |
| . | Liso-cel–treated set (N = 270) . |
|---|---|
| Sex, n (%) | |
| Male | 174 (64) |
| Female | 96 (36) |
| Median age (range), y | 63 (18-86) |
| ≥65 y | 112 (41) |
| ≥75 y | 27 (10) |
| Ethnicity, n (%) | |
| Not Hispanic or Latino | 233 (86) |
| Hispanic or Latino | 27 (10) |
| Not reported | 10 (4) |
| Race, n (%) | |
| White | 233 (86) |
| Black or African American | 12 (4) |
| Asian | 11 (4) |
| American Indian or Alaska Native | 2 (<1) |
| Multiple | 1 (<1) |
| Not reported | 11 (4) |
| Non-Hodgkin lymphoma subtypes, n (%) | |
| Diffuse LBCL, not otherwise specified | 137 (51) |
| Diffuse LBCL transformed from indolent lymphoma | 78 (29) |
| Transformed from follicular lymphoma | 60 (22) |
| Transformed from other indolent non-Hodgkin lymphoma subtypes | 18 (7) |
| High-grade B-cell lymphoma with gene rearrangements in MYC and either BCL2, BCL6, or both | 36 (13) |
| Primary mediastinal B-cell lymphoma | 15 (6) |
| Follicular lymphoma grade 3B | 4 (1) |
| ECOG PS at screening, n (%) | |
| 0 | 111 (41) |
| 1 | 155 (57) |
| 2 | 4 (1) |
| Before lymphodepleting chemotherapy | |
| Median sum of the product of perpendicular diameters (range), cm2 | 22.5 (0.8-418.6) |
| Sum of the product of perpendicular diameters ≥50 cm2, n (%) | 73 (28) |
| Median lactate dehydrogenase (range), U/L | 264.5 (112-11 933) |
| Lactate dehydrogenase ≥500 U/L, n (%) | 58 (21) |
| Creatinine clearance <60 mL/min, n (%) | 51 (19) |
| Median baseline C-reactive protein (range), mg/L | 27.4 (0.25-2158.0) |
| Left ventricular ejection fraction ≥40% and <50%, n (%) | 13 (5) |
| Median previous lines of systemic therapy (range) | 3 (1-8) |
| Number of previous lines of systemic therapy,∗ n (%) | |
| 1 | 9 (3) |
| 2 | 122 (45) |
| 3 | 68 (25) |
| ≥4 | 71 (26) |
| Chemotherapy refractory,† n (%) | 181 (67) |
| Received previous HSCT, n (%) | 94 (35) |
| Autologous HSCT | 90 (33) |
| Allogeneic HSCT | 9 (3) |
| Never achieved CR with previous therapy, n (%) | 119 (44) |
| Secondary CNS lymphoma, n (%) | 7 (3) |
| Received bridging therapy, n (%) | 159 (59) |
ECOG PS, Eastern Cooperative Oncology Group performance status; HSCT, hematopoietic stem cell transplantation.
The original study protocol enrolled patients with ≥2 previous lines of treatment, including 9 patients who had received 1 line of systemic treatment plus consolidation with HSCT or radiation. The protocol was amended to require at least 2 previous lines of systemic treatment.
The status was chemotherapy refractory if the patient achieved stable disease or progressive disease to the last chemotherapy-containing regimen or relapsed <12 months after autologous stem cell transplantation; otherwise, the status was chemotherapy sensitive.