Patient baseline characteristics and eligibility according to ZUMA-1 criteria
| Variables . | n (%) . |
|---|---|
| UC study cohort | N = 416 |
| Baseline characteristics | |
| Primary disease type, n (%) | |
| DLBCL | 335 (80.5) |
| DLBCL/TFL/PMBCL | 81 (19.5) |
| Age | |
| Median (range), y | 63.0 (54-70) |
| ≥65, n (%) | 192 (46.1) |
| Male sex, n (%) | 271 (65.1) |
| BMI (kg/m2) | |
| Median (range) | 25.6 (23.1-28.9) |
| ≥25, n (%) | 245 (58.9) |
| Race, n (%) | |
| White | 232 (55.8) |
| Asian | 43 (10.3) |
| Black or African American, or Native Hawaiian or Other Pacific Islander, or American Indian or Alaska Native | 15 (3.6) |
| Native Hawaiian or Other Pacific Islander, or American Indian or Alaska Native | 5 (1.2) |
| Other or unknown | 126 (30.3) |
| Previous autologous stem cell transplant, n (%) | 31 (7.5) |
| Previous allogeneic stem cell transplant,∗ n (%) | 5 (1.2) |
| CAR-T preparation procedures, median (range) | |
| Leukapheresis to infusion days (v2v) | 28 (26-34) |
| Initiation of LD therapy (days before axi-cel) | 5 (5-5) |
| Received LD for >3 days, n (%) | 17 (4.1) |
| Deviation from the recommended axi-cel infusion timeline,† n (%) | 94 (22.6) |
| Last day of LD, median (range) | 3 (3-3) |
| Eligibility at leukapheresis | |
| Inadequate hematological, organ function, or having infection, n (%) | 66 (15.9) |
| Inadequate hematological profile, n (%) | 66 (15.9) |
| ANC of <1000 × 106/L | 13 (3.1) |
| Lymphocyte count of <100 × 106/L | 1 (0.2) |
| Platelet count at <75 000 × 106/L | 18 (4.3) |
| Organ function and infection, n (%) | |
| ALT > 2.5 ULN | 4 (1.0) |
| AST > 2.5 ULN | 2 (0.5) |
| Total bilirubin of >1.5 mg/dL | 4 (1.0) |
| EGFR < 60 mL/min | 23 (5.5) |
| EF < 50% | 1 (0.2) |
| O2 of <92% on room air | 0 (0.0) |
| Active infection | 0 (0.0) |
| Having history or presence of comorbidities,‡ n (%) | 139 (33.4) |
| CNS disorders | 31 (7.5) |
| CNS lymphoma or metastasis | 4 (1.0) |
| Myocardial complications | 81 (19.5) |
| Thrombosis | 51 (12.3) |
| Autoimmune diseases | 30 (7.2) |
| Bridging therapy | |
| Required bridging therapy, n (%) | 165 (39.7) |
| Rituximab-containing regimen | 104 (63.0) |
| RW patients who would not have been eligible and studied in ZUMA-1, n (%) (Patients did not meet eligibility criteria or required bridging therapies) | 239 (57.5) |
| Variables . | n (%) . |
|---|---|
| UC study cohort | N = 416 |
| Baseline characteristics | |
| Primary disease type, n (%) | |
| DLBCL | 335 (80.5) |
| DLBCL/TFL/PMBCL | 81 (19.5) |
| Age | |
| Median (range), y | 63.0 (54-70) |
| ≥65, n (%) | 192 (46.1) |
| Male sex, n (%) | 271 (65.1) |
| BMI (kg/m2) | |
| Median (range) | 25.6 (23.1-28.9) |
| ≥25, n (%) | 245 (58.9) |
| Race, n (%) | |
| White | 232 (55.8) |
| Asian | 43 (10.3) |
| Black or African American, or Native Hawaiian or Other Pacific Islander, or American Indian or Alaska Native | 15 (3.6) |
| Native Hawaiian or Other Pacific Islander, or American Indian or Alaska Native | 5 (1.2) |
| Other or unknown | 126 (30.3) |
| Previous autologous stem cell transplant, n (%) | 31 (7.5) |
| Previous allogeneic stem cell transplant,∗ n (%) | 5 (1.2) |
| CAR-T preparation procedures, median (range) | |
| Leukapheresis to infusion days (v2v) | 28 (26-34) |
| Initiation of LD therapy (days before axi-cel) | 5 (5-5) |
| Received LD for >3 days, n (%) | 17 (4.1) |
| Deviation from the recommended axi-cel infusion timeline,† n (%) | 94 (22.6) |
| Last day of LD, median (range) | 3 (3-3) |
| Eligibility at leukapheresis | |
| Inadequate hematological, organ function, or having infection, n (%) | 66 (15.9) |
| Inadequate hematological profile, n (%) | 66 (15.9) |
| ANC of <1000 × 106/L | 13 (3.1) |
| Lymphocyte count of <100 × 106/L | 1 (0.2) |
| Platelet count at <75 000 × 106/L | 18 (4.3) |
| Organ function and infection, n (%) | |
| ALT > 2.5 ULN | 4 (1.0) |
| AST > 2.5 ULN | 2 (0.5) |
| Total bilirubin of >1.5 mg/dL | 4 (1.0) |
| EGFR < 60 mL/min | 23 (5.5) |
| EF < 50% | 1 (0.2) |
| O2 of <92% on room air | 0 (0.0) |
| Active infection | 0 (0.0) |
| Having history or presence of comorbidities,‡ n (%) | 139 (33.4) |
| CNS disorders | 31 (7.5) |
| CNS lymphoma or metastasis | 4 (1.0) |
| Myocardial complications | 81 (19.5) |
| Thrombosis | 51 (12.3) |
| Autoimmune diseases | 30 (7.2) |
| Bridging therapy | |
| Required bridging therapy, n (%) | 165 (39.7) |
| Rituximab-containing regimen | 104 (63.0) |
| RW patients who would not have been eligible and studied in ZUMA-1, n (%) (Patients did not meet eligibility criteria or required bridging therapies) | 239 (57.5) |
ALT, alanine aminotransferase; ANC, absolute neutrophil count; AST, aspartate aminotransferase; BMI, body mass index; CNS, central nervous system; EF, ejection fraction; EGFR, estimated glomerular filtration rate; LD, lymphodepleting; PMBCL, primary mediastinal large B-cell lymphoma; TFL, transformed follicular lymphoma; v2v, vein-to-vein.
History of allogeneic stem cell transplants was part of the exclusion criteria described in ZUMA-1.
Of 94 patients, 87 received axi-cel >3 days after the completion of lymphodepleting therapy; the remaining 7 patients received axi-cel within 1 and 2 days after the completion of lymphodepleting therapy.
Indicates number and percentage of patients with comorbidities who would have been excluded in ZUMA-1. This includes allogeneic stem cell transplantation listed earlier in the table.