Table 1.
Demographics and baseline disease characteristics (ITT set)
| Characteristics | Liso-cel (n = 92) | SOC (n = 92) |
|---|---|---|
| Male sex, n (%) | 44 (48) | 61 (66) |
| Age, y | ||
| Median (range) | 60 (20-74) | 58 (26-75) |
| <65, n (%) | 56 (61) | 67 (73) |
| ≥65 to <75, n (%) | 36 (39) | 23 (25) |
| 75, n (%) | 0 | 2 (2) |
| LBCL subtypes,∗n (%) | ||
| DLBCL NOS | 53 (58) | 50 (54) |
| DLBCL transformed from indolent lymphomas | 7 (8) | 8 (9) |
| FL grade 3B | 1 (1) | 0 |
| HGBCL with gene rearrangements in MYC and BCL2, BCL6, or both† | 22 (24) | 21 (23) |
| PMBCL | 8 (9) | 9 (10) |
| THRBCL | 1 (1) | 4 (4) |
| ECOG PS, n (%) | ||
| 0 | 48 (52) | 57 (62) |
| 1 | 44 (48) | 35 (38) |
| sAAIPI, n (%) | ||
| 0 or 1 | 56 (61) | 55 (60) |
| 2 or 3 | 36 (39) | 37 (40) |
| Prior response status, n (%) | ||
| Refractory‡ | 67 (73) | 70 (76) |
| Relapsed§ | 25 (27) | 22 (24) |
| Ann Arbor stage, n (%) | ||
| 1 | 8 (9) | 14 (15) |
| 2 | 16 (17) | 15 (16) |
| 3 | 18 (20) | 13 (14) |
| 4 | 50 (54) | 50 (54) |
| SPD, median (range), cm2 | 11.4 (1-120) | 15.7 (1-224) |
| SPD >50 cm2, n (%) | 10 (11) | 10 (11) |
| Missing | 5 (5) | 6 (7) |
| Secondary CNS lymphoma, n (%) | 1 (1) | 3 (3) |
| Best response to first-line therapy, n (%) | ||
| CR | 30 (33) | 28 (30) |
| PR | 36 (39) | 46 (50) |
| Stable disease | 7 (8) | 5 (5) |
| Progressive disease | 19 (21) | 13 (14) |
| Not evaluable | 0 | 0 |
| Median (range) time from initial diagnosis to randomization, mo | 7.6 (2.0-21.5) | 7.7 (2.5-25.4) |
CNS, central nervous system; DLBCL, diffuse large B-cell lymphoma; ECOG PS, Eastern Cooperative Oncology Group performance status; FL, follicular lymphoma; HGBCL, high-grade B-cell lymphoma; ITT, intention-to-treat; NOS, not otherwise specified; PMBCL, primary mediastinal large B-cell lymphoma; sAAIPI, secondary age-adjusted International Prognostic Index; SPD, sum of the product of perpendicular diameters; THRBCL, T-cell/histiocyte-rich large B-cell lymphoma.
Based on World Health Organization 2016 classification, as reported by the investigator.
Fluorescence in situ hybridization results were assessed locally but subsequently confirmed by a central laboratory.
Defined as stable disease, progressive disease, PR, or CR with relapse <3 months after first-line therapy.
Defined as CR with relapse on or after 3 months within 12 months after first-line therapy.