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Clinical factor
|
OS
|
|---|
|
ZUMA-1 (axi-cel) phase 2 mITT set
|
TRANSCEND (liso-cel) LBCL efficacy set
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|---|
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Before MAIC (naïve)
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After MAIC (SA1)
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After MAIC (SA2)
|
|---|
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N/ESS
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N = 101
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N = 256
|
ESS = 152.6
|
ESS = 98.9
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|---|
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Stat
|
Stat
|
SMD
|
Stat
|
SMD
|
Stat
|
SMD
|
|---|
|
Age, years, mean (SD)
|
56.3 (12.0)
|
60.3 (13.3)
|
0.308
|
56.3 (12.0)
|
0.000
|
56.3 (12.0)
|
0.000
|
|
Male sex, %
|
67.3
|
66.0
|
0.027
|
68.3
|
0.020
|
67.3
|
0.000
|
|
IPI score, %*
|
|
0–2
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54.5
|
58.6
|
0.162
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54.5
|
0.000
|
54.5
|
0.000
|
|
3–4
|
45.5
|
39.8
| |
45.5
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45.5
| |
|
5
|
0.0
|
0.8
| |
0.0
| |
0.0
| |
|
Missing
|
0.0
|
0.8
| |
0.0
| |
0.0
| |
|
ECOG PS at screening, %
|
|
0
|
41.6
|
40.6
|
0.178
|
37.9
|
0.075
|
41.6
|
0.000
|
|
1
|
58.4
|
57.8
| |
62.1
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58.4
| |
|
2
|
0.0
|
1.6
| |
0.0
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0.0
| |
|
Disease stage, %
|
|
I or II
|
14.9
|
27.0
|
0.304
|
23.5
|
0.219
|
14.9
|
0.000
|
|
III or IV
|
85.1
|
72.3
| |
76.5
| |
85.1
| |
|
Missing
|
0.0
|
0.8
| |
0.0
| |
0.0
| |
|
Tumor burden based on SPD before LDC, cm2, mean (SD)†
|
50.4
(43.7)
|
43.7 (48.1)
|
0.142
|
50.4 (43.8)
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0.000
|
50.4 (43.9)
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0.000
|
|
Secondary CNS disease at time of treatment, %
|
|
No
|
100.0
|
97.7
|
0.219
|
100.0
|
0.000
|
100.0
|
0.000
|
|
Yes
|
0.0
|
2.3
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0.0
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0.0
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|
Extranodal disease, %
|
|
No
|
30.7
|
46.9
|
0.344
|
42.9
|
0.255
|
30.7
|
0.000
|
|
Yes
|
69.3
|
52.3
| |
57.1
| |
69.3
| |
|
Missing
|
0.0
|
0.8
| |
0.0
| |
0.0
| |
|
Bulky disease, %
|
|
No
|
83.2
|
87.9
|
0.155
|
83.2
|
0.000
|
83.2
|
0.000
|
|
Yes
|
16.8
|
11.3
| |
16.8
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16.8
| |
|
Missing
|
0.0
|
0.8
| |
0.0
| |
0.0
| |
|
Disease histology, %
|
|
DLBCL‡
|
76.2
|
71.1
|
0.242
|
76.3
|
0.000
|
76.3
|
0.000
|
|
DLBCL tFL
|
15.8
|
22.3
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15.8
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15.8
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|
PMBCL
|
7.9
|
5.5
| |
7.9
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7.9
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|
FL3B
|
0.0
|
1.2
| |
0.0
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0.0
| |
|
No. of lines of prior therapy, %§
|
|
1
|
3.0
|
0.8
|
0.179
|
0.2
|
0.228
|
3.0
|
0.000
|
|
2
|
27.7
|
25.0
| |
25.9
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27.7
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|
≥ 3
|
69.3
|
73.8
| |
73.9
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69.3
| |
|
Missing
|
0.0
|
0.4
| |
0.0
| |
0.0
| |
|
Prior allo-HSCT, %
|
0.0
|
2.7
|
0.237
|
0.0
|
0.000
|
0.0
|
0.000
|
|
Prior auto-HSCT, %
|
24.8
|
33.2
|
0.186
|
31.4
|
0.148
|
24.8
|
0.000
|
|
Bridging therapy, %
|
|
No
|
100.0
|
41.4
|
1.682
|
35.0
|
1.925
|
35.9
|
1.889
|
|
Yes
|
0.0
|
58.6
| |
65.0
| |
64.1
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|
R/R to last therapy, %¶
|
|
Relapsed
|
20.8
|
35.9
|
0.359
|
20.8
|
0.000
|
20.8
|
0.000
|
|
Refractory
|
79.2
|
61.7
| |
79.2
| |
79.2
| |
|
Missing
|
0.0
|
2.3
| |
0.0
| |
0.0
| |
|
CrCl before LDC, %#
|
|
< 60 mL/min
|
0.0
|
19.1
|
0.688
|
13.4
|
0.557
|
0.0
|
0.000
|
|
≥ 60 mL/min
|
100.0
|
80.9
| |
86.8
| |
100.0
| |
|
LVEF at screening, %#
|
|
< 50%
|
0.0
|
5.1
|
0.327
|
4.3
|
0.300
|
0.0
|
0.000
|
|
≥ 50%
|
100.0
|
94.9
| |
95.7
| |
100.0
| |
|
Pre-leukapheresis ALC (109/L), %#
|
|
< 0.1
|
0.0
|
0.4
|
0.091
|
0.2
|
0.067
|
0.0
|
0.000
|
|
≥ 0.1
|
100.0
|
94.1
| |
94.2
| |
100.0
| |
|
Missing
|
0.0
|
5.5
| |
5.6
| |
0.0
| |
|
Statistics, %
|
|
Factors with SMD < 0.2
|
NA
|
44.4
|
NA
|
66.7
|
NA
|
94.4
|
NA
|
|
Factors with SMD < 0.1
|
NA
|
11.1
|
NA
|
61.1
|
NA
|
94.4
|
NA
|
- ALC, absolute lymphocyte count; allo-HSCT, allogeneic hematopoietic stem cell transplantation; auto-HSCT, autologous hematopoietic stem cell transplantation; axi-cel, axicabtagene ciloleucel; CNS, central nervous system; CrCl, creatinine clearance; DLBCL, diffuse large B cell lymphoma; ECOG PS, Eastern Cooperative Oncology Group performance status; ESS, effective sample size; FL3B, follicular lymphoma grade 3B; HGBCL, high-grade B cell lymphoma; IPI, International Prognostic Index; LBCL, large B cell lymphoma; liso-cel, lisocabtagene maraleucel; LDC, lymphodepleting chemotherapy; LVEF, left ventricular ejection fraction; MAIC, matching-adjusted indirect comparison; mITT, modified intention to treat; N, sample size; NA, not applicable; NOS, not otherwise specified; OS, overall survival; PMBCL, primary mediastinal B cell lymphoma; R/R, relapsed or refractory; SA1, sensitivity analysis 1; SA2, sensitivity analysis 2; SD, standard deviation; SMD, standard mean difference; SPD, sum of the product of perpendicular diameters; Stat, statistic; tFL, transformed follicular lymphoma; tiNHL, transformed indolent non-Hodgkin lymphoma
- *Per ZUMA-1 categorization
- †Per investigator assessment
- ‡Includes DLBCL NOS, HGBCL, and tiNHL for TRANSCEND; includes DLBCL NOS and HGBCL for ZUMA-1
- §Per ZUMA-1, salvage chemotherapy and auto-HSCT were considered separate regimens
- ¶Per ZUMA-1, refractory was defined as best response to last therapy of progressive disease or stable disease and relapsed defined as best response to last therapy of partial response or complete response
- #Per ZUMA-1 eligibility criteria, all patients enrolled in ZUMA-1 had CrCl ≥ 60 mL/min before LDC, LVEF ≥ 50% at screening, and
pre-leukapheresis ALC ≥ 0.1 × 109/L
