Table 1.

Demographics and baseline disease characteristics (ITT set)

CharacteristicsLiso-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 (%) 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) 
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 (%)   
48 (52) 57 (62) 
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 (%)   
8 (9) 14 (15) 
16 (17) 15 (16) 
18 (20) 13 (14) 
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 
Median (range) time from initial diagnosis to randomization, mo 7.6 (2.0-21.5) 7.7 (2.5-25.4) 
CharacteristicsLiso-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 (%) 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) 
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 (%)   
48 (52) 57 (62) 
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 (%)   
8 (9) 14 (15) 
16 (17) 15 (16) 
18 (20) 13 (14) 
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 
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.

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