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Safety outcome, scenario
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ZUMA-1 (axi-cel) phase 1/2 safety analysis set
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TRANSCEND (liso-cel) LBCL-treated set
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Liso-cel versus axi-cel
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|---|
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N
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Event rate, %
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N/ESS
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Event rate, %
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OR (95% CI)
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P
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|---|
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CRS, per Lee 2014 criteria
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|
All grade
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Naïve
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108
|
92.6
|
269
|
42.0
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0.06 (0.03–0.12)
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< 0.001
|
|
Initial
| | |
63.0
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26.6
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0.03 (0.01–0.07)
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< 0.001
|
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Sensitivity
| | |
209.9
|
42.9
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0.06 (0.03–0.13)
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< 0.001
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|
Grade ≥ 3
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Naïve
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108
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11.1
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269
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2.2
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0.18 (0.07–0.50)
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0.001
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Initial
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63.0
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1.0
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0.08 (0.01–0.67)
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0.019
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Sensitivity
| | |
209.9
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2.0
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0.16 (0.06–0.47)
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0.001
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|
NE, study-specific
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All grade
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Naïve
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108
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66.7
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269
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29.7
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0.21 (0.13–0.34)
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< 0.001
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|
Initial
| | |
63.0
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24.6
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0.16 (0.08–0.33)
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< 0.001
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Sensitivity
| | |
209.9
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29.8
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0.21 (0.13–0.35)
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< 0.001
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|
Grade ≥ 3
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|
Naïve
|
108
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32.4
|
269
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10.0
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0.23 (0.13–0.41)
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< 0.001
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|
Initial
| | |
63.0
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2.5
|
0.05 (0.02–0.15)
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< 0.001
|
|
Sensitivity
| | |
209.9
|
8.7
|
0.20 (0.11–0.37)
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< 0.001
|
|
NE of encephalopathy, group term
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|
All grade
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|
Naïve
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108
|
37.0
|
269
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21.2
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0.46 (0.28–0.75)
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0.002
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|
Initial
| | |
63.0
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19.8
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0.42 (0.19–0.91)
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0.028
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Sensitivity
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209.9
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20.4
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0.44 (0.26–0.73)
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0.002
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|
Grade ≥ 3
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Naïve
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108
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23.1
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269
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6.7
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0.24 (0.12–0.46)
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< 0.001
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|
Initial
| | |
63.0
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1.5
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0.05 (0.01–0.18)
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< 0.001
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Sensitivity
| | |
209.9
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5.6
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0.20 (0.09–0.41)
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< 0.001
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|
NE of aphasia, group term
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|
All grade
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|
Naïve
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108
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17.6
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269
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9.7
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0.50 (0.26–0.95)
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0.034
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|
Initial
| | |
63.0
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7.2
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0.36 (0.13–1.00)
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0.049
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|
Sensitivity
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209.9
|
9.7
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0.51 (0.26–1.00)
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0.049
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|
Grade ≥ 3
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|
Naïve
|
108
|
7.4
|
269
|
1.9
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0.24 (0.08–0.74)
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0.014
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|
Initial*
| | |
–
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–
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–
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–
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|
Sensitivity
| | |
209.9
|
1.5
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0.19 (0.06–0.61)
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0.005
|
|
Infections, any pathogens, per infections and infestations SOC
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|
Grade ≥ 3
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|
Naïve
|
108
|
26.0
|
269
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12.3
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0.40 (0.23–0.70)
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0.001
|
|
Initial
| | |
63.0
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6.3
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0.19 (0.07–0.49)
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0.001
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Sensitivity
| | |
209.9
|
11.2
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0.36 (0.20–0.65)
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0.001
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|
Prolonged anemia, reported as AE
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|
Grade ≥ 3
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|
Naïve
|
108
|
10.2
|
269
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5.9
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0.56 (0.25–1.24)
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0.153
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|
Initial
| | |
63.0
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0.4
|
0.04 (0.00–0.32)
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0.002
|
|
Sensitivity
| | |
209.9
|
4.9
|
0.46 (0.20–1.05)
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0.064
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|
Prolonged neutropenia, reported as AE
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|
Grade ≥ 3
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Naïve
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108
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25.9
|
269
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14.1
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0.47 (0.27–0.82)
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0.007
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|
Initial
| | |
63.0
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13.6
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0.45 (0.19–1.07)
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0.072
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Sensitivity
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209.9
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15.3
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0.52 (0.29–0.91)
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0.022
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Prolonged thrombocytopenia, reported as AE
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|
Grade ≥ 3
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Naïve
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108
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24.1
|
269
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17.5
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0.67 (0.39–1.15)
|
0.143
|
|
Initial
| | |
63.0
|
6.9
|
0.23 (0.10–0.57)
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0.001
|
|
Sensitivity
| | |
209.9
|
16.3
|
0.61 (0.35–1.08)
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0.090
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|
Hypogammaglobulinemia,† group term
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|
All grade
|
|
Naïve
|
108
|
16.0
|
269
|
13.8
|
0.84 (0.45–1.56)
|
0.575
|
|
Initial
| | |
63.0
|
6.6
|
0.37 (0.14–0.97)
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0.043
|
|
Sensitivity
| | |
209.9
|
11.9
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0.71 (0.37–1.37)
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0.311
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- TEAEs are reported unless otherwise specified
- AE, adverse event; axi-cel, axicabtagene ciloleucel; CI, confidence interval; CRS, cytokine release syndrome; ESS, effective sample size; LBCL, large B cell lymphoma; liso-cel, lisocabtagene maraleucel; MAIC, matching-adjusted indirect comparison; N, sample size; NA, not applicable; NE, neurological event; OR, odds ratio; SOC, system organ class; TEAE, treatment-emergent adverse event
- *MAICs not possible because all patients with grade ≥ 3 events would have been excluded during matching
- †Represents TEAE assessed by investigators
