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Table 5 Summary of MAIC results for safety outcomes of liso-cel versus axi-cel

From: Matching-adjusted indirect treatment comparison of liso-cel versus axi-cel in relapsed or refractory large B cell lymphoma

Safety outcome, scenario

ZUMA-1 (axi-cel) phase 1/2 safety analysis set

TRANSCEND (liso-cel) LBCL-treated set

Liso-cel versus axi-cel

N

Event rate, %

N/ESS

Event rate, %

OR (95% CI)

P

CRS, per Lee 2014 criteria

 All grade

  Naïve

108

92.6

269

42.0

0.06 (0.03–0.12)

 < 0.001

  Initial

  

63.0

26.6

0.03 (0.01–0.07)

 < 0.001

  Sensitivity

  

209.9

42.9

0.06 (0.03–0.13)

 < 0.001

 Grade ≥ 3

  Naïve

108

11.1

269

2.2

0.18 (0.07–0.50)

0.001

  Initial

  

63.0

1.0

0.08 (0.01–0.67)

0.019

  Sensitivity

  

209.9

2.0

0.16 (0.06–0.47)

0.001

NE, study-specific

 All grade

  Naïve

108

66.7

269

29.7

0.21 (0.13–0.34)

 < 0.001

  Initial

  

63.0

24.6

0.16 (0.08–0.33)

 < 0.001

  Sensitivity

  

209.9

29.8

0.21 (0.13–0.35)

 < 0.001

 Grade ≥ 3

  Naïve

108

32.4

269

10.0

0.23 (0.13–0.41)

 < 0.001

  Initial

  

63.0

2.5

0.05 (0.02–0.15)

 < 0.001

  Sensitivity

  

209.9

8.7

0.20 (0.11–0.37)

 < 0.001

NE of encephalopathy, group term

 All grade

  Naïve

108

37.0

269

21.2

0.46 (0.28–0.75)

0.002

  Initial

  

63.0

19.8

0.42 (0.19–0.91)

0.028

  Sensitivity

  

209.9

20.4

0.44 (0.26–0.73)

0.002

 Grade ≥ 3

  Naïve

108

23.1

269

6.7

0.24 (0.12–0.46)

 < 0.001

  Initial

  

63.0

1.5

0.05 (0.01–0.18)

 < 0.001

  Sensitivity

  

209.9

5.6

0.20 (0.09–0.41)

 < 0.001

NE of aphasia, group term

 All grade

  Naïve

108

17.6

269

9.7

0.50 (0.26–0.95)

0.034

  Initial

  

63.0

7.2

0.36 (0.13–1.00)

0.049

  Sensitivity

  

209.9

9.7

0.51 (0.26–1.00)

0.049

 Grade ≥ 3

  Naïve

108

7.4

269

1.9

0.24 (0.08–0.74)

0.014

  Initial*

  

–

–

–

–

  Sensitivity

  

209.9

1.5

0.19 (0.06–0.61)

0.005

Infections, any pathogens, per infections and infestations SOC

 Grade ≥ 3

  Naïve

108

26.0

269

12.3

0.40 (0.23–0.70)

0.001

  Initial

  

63.0

6.3

0.19 (0.07–0.49)

0.001

  Sensitivity

  

209.9

11.2

0.36 (0.20–0.65)

0.001

Prolonged anemia, reported as AE

 Grade ≥ 3

  Naïve

108

10.2

269

5.9

0.56 (0.25–1.24)

0.153

  Initial

  

63.0

0.4

0.04 (0.00–0.32)

0.002

  Sensitivity

  

209.9

4.9

0.46 (0.20–1.05)

0.064

Prolonged neutropenia, reported as AE

 Grade ≥ 3

  Naïve

108

25.9

269

14.1

0.47 (0.27–0.82)

0.007

  Initial

  

63.0

13.6

0.45 (0.19–1.07)

0.072

  Sensitivity

  

209.9

15.3

0.52 (0.29–0.91)

0.022

Prolonged thrombocytopenia, reported as AE

 Grade ≥ 3

  Naïve

108

24.1

269

17.5

0.67 (0.39–1.15)

0.143

  Initial

  

63.0

6.9

0.23 (0.10–0.57)

0.001

  Sensitivity

  

209.9

16.3

0.61 (0.35–1.08)

0.090

Hypogammaglobulinemia,† group term

 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)

0.043

  Sensitivity

  

209.9

11.9

0.71 (0.37–1.37)

0.311

  1. TEAEs are reported unless otherwise specified
  2. 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
  3. *MAICs not possible because all patients with grade ≥ 3 events would have been excluded during matching
  4. †Represents TEAE assessed by investigators
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Journal of Hematology & Oncology

ISSN: 1756-8722

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