Matching-adjusted indirect treatment comparison of chimeric antigen receptor T-cell therapies for third-line or later treatment of relapsed or refractory large B-cell lymphoma: lisocabtagene maraleucel versus tisagenlecleucel

Table 6 MAIC results for safety outcomes in the comparison of liso-cel to tisagenlecleucel

Safety outcomes	Grades	JULIET (tisagenlecleucel) efficacy analysis set [8]	TRANSCEND (liso-cel) DLBCL efficacy set [6]		Liso-cel vs tisagenlecleucel, OR (95% CI)
		Reported rates, %	Naive, %	MAIC, %	Naive	P-value	MAIC	P-value
		(N = 111)	(N = 269)	(ESS = 122.9)	Naive	P-value	MAIC	P-value
CRS, Lee 2014 criteria	All grades	56.8	42.0	41.1	0.55 (0.35‒0.86)	0.009	0.53 (0.32‒0.89)	0.016
CRS, Lee 2014 criteria	Grade ≥ 3	17.1	2.2	2.0	0.11 (0.04‒0.29)	< 0.001	0.10 (0.03‒0.31)	< 0.001
NE, per study-specific definition	All grades	21	29.7	21.0	1.59 (0.94‒2.70)	0.085	1.36 (0.76‒2.44)	0.306
NE, per study-specific definition	Grade ≥ 3	12	10.0	9.7	0.82 (0.41‒1.65)	0.576	0.79 (0.36‒1.73)	0.551
Encephalopathy, per study-specific definition^a	All grades	6	6.3	6.5	1.06 (0.42‒2.67)	0.907	1.09 (0.38‒3.12)	0.867
Aphasia, per study-specific definition^a	All grades	3	8.2	6.4	2.88 (0.89‒9.33)	0.078	2.21 (0.64‒7.61)	0.209
Infections, any pathogens, per infections and infestations SOC	Grade ≥ 3	19.8	12.3	12.1	0.57 (0.31‒1.02)	0.060	0.56 (0.28‒1.10)	0.090
Hypogammaglobulinemia^a, grouped term	All grades	14^b	13.8	10.0	0.98 (0.52‒1.85)	0.949	0.68 (0.33‒1.43)	0.313
Prolonged cytopenia, laboratory assessment	Grade ≥ 3	52.8^c (n = 106)	37.2	32.8	0.53 (0.34‒0.83)	0.006	0.44 (0.26‒0.73)	0.002

CRS cytokine release syndrome, DLBCL diffuse large B-cell lymphoma, ESS effective sample size, liso-cel lisocabtagene maraleucel, MAIC matching-adjusted indirect comparison, NE neurological event, OR odds ratio, SOC System Organ Class, TEAE treatment-emergent adverse event
^aRepresents TEAE as assessed by investigators
^bReporting time was not specified
^cProlonged cytopenia by laboratory assessment was reported for n = 106 (data cutoff: September 6, 2017; Kymriah [Summary Basis for Regulatory Action]) [35]. Prolonged cytopenia per investigator assessment was reported for N = 111 in Schuster et al. [8] but could not be used owing to differences in assessment approach

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