Table 1.
Baseline characteristics of all enrolled patients
| Characteristic | FL (n = 127) |
MZL (n = 31) |
All patients (N = 159)∗ |
|---|---|---|---|
| Age, median (range), y | 60 (34-79) | 64 (43-77) | 60 (34-79) |
| ≥65 y, n (%) | 40 (31) | 14 (45) | 54 (34) |
| Male sex, n (%) | 75 (59) | 15 (48) | 90 (57) |
| FL histological category, n (%) | |||
| Grade 1 | 34 (27) | — | — |
| Grade 2 | 63 (50) | — | — |
| Grade 3a | 30 (24) | — | — |
| MZL histological category, n (%) | |||
| Nodal | — | 10 (32) | — |
| Extranodal | — | 21 (68) | — |
| ECOG PS of 1, n (%) | 48 (38) | 16 (52) | 65 (41) |
| Stage III-IV disease, n (%) | 109 (86) | 29 (94) | 139 (87) |
| High-risk FLIPI (≥3), n (%) | 56 (44) | — | — |
| High tumor bulk (GELF criteria), n (%)† | 65 (51) | 16 (52) | 82 (52) |
| SPD, median (range), mm2 | 2604.15 (289.2-34 675.0) | 1746.45 (306.5-7 471.8) | 2449.50 (289.2-34 675.0) |
| TMTV, median (range), mL | 438.50 (11.21-5 576.58) | 368.83 (5.15-3 239.43) | 420.33 (5.15-5 576.58) |
| Number of prior therapies, median (range)‡ | 3 (1-10) | 3 (2-8) | 3 (1-10) |
| 3 prior lines of therapy, n (%) | 33 (26) | 10 (32) | 44 (28) |
| 4 prior lines of therapy, n (%) | 25 (20) | 1 (3) | 26 (16) |
| ≥5 prior lines of therapy, n (%) | 22 (17) | 9 (29) | 31 (19) |
| Prior PI3K inhibitor, n (%) | 36 (28) | 10 (32) | 46 (29) |
| Prior autologous SCT, n (%) | 30 (24) | 4 (13) | 34 (21) |
| Prior anti-CD20 mAb single agent, n (%) | 40 (31) | 11 (35) | 51 (32) |
| Prior lenalidomide, n (%) | 38 (30) | 9 (29) | 48 (30) |
| Prior bendamustine, n (%) | 88 (69) | 24 (77) | 113 (71) |
| ≤6 mo of leukapheresis | 8 (6) | 3 (10) | 11 (7) |
| ≥6 mo and <12 mo of leukapheresis | 10 (8) | 1 (3) | 12 (8) |
| >12 mo of leukapheresis | 70 (55) | 20 (65) | 90 (57) |
| R/R subgroup, n (%) | |||
| Refractory to last prior therapy | 87 (69) | 25 (81) | 113 (71) |
| Double refractory to prior anti-CD20 mAb and alkylating agent | 56 (44) | 13 (42) | 70 (44) |
| POD24 from initiating first anti-CD20 mAb–containing therapy§ | 70 (56) | 18 (60) | 89 (57) |
| Lymphoma present in bone marrow, n (%)‖ | 35 (28) | 14 (45) | 49 (31) |
| Received bridging therapy, n (%) | 4 (3) | 3 (10) | 7 (4) |
DLBCL, diffuse large B-cell lymphoma; ECOG PS, Eastern Cooperative Oncology Group performance status; FLIPI, Follicular Lymphoma International Prognostic Index; GELF, Groupe d'Etude des Lymphomes Folliculaires; mAb, monoclonal antibody; PI3K, phosphatidylinositol-3-kinase; SCT, stem cell transplantation.
One patient was found to have disease type DLBCL after enrollment via pretreatment biopsy. This patient did not receive axi-cel and discontinued the study.
High tumor bulk, as defined by any of GELF criteria: involvement of ≥3 nodal sites, each with a diameter of ≥3 cm, any nodal or extranodal tumor mass with a diameter of ≥7 cm, B symptoms, splenomegaly, pleural effusions or peritoneal ascites, cytopenias, or leukemia.
One patient received prior therapy for DLBCL, not for the primary disease of FL.
Proportions are based on the number of patients who ever received anti-CD20–chemotherapy combination therapy.
Bone marrow was assessed by the investigator at baseline for lymphoma presence per Lugano11 bone marrow assessment/bone marrow assessment using aspirate or core biopsy at screening. If these were not available, lymphoma presence was based on diagnosis history of bone marrow involvement.