Table 1.

Summary of datasets

Treatment	Study name	Data cutoffa (MM/DD/YYYY)	Median study follow-up, months (range)	Analysis set	N
Efficacy outcomes
Liso-cel	TRANSCEND [6]	08/12/2019	11.5 (0.2‒35.0)b	DLBCL efficacy set	256
Tisagenlecleucel—ORR, CR rate	JULIET [8]	12/08/2017	14 (0.1‒26)c	Efficacy analysis set	93
Tisagenlecleucel—PFS, OS	JULIET [8]	12/08/2017	14 (0.1‒26)b	Safety set/full analysis set	111
Safety outcomes
Liso-cel	TRANSCEND [6]	08/12/2019	11.5 (0.2‒35.0)b	DLBCL-treated set	269
Tisagenlecleucel	JULIET [8]	12/08/2017	14 (0.1‒26)c	Safety set/full analysis set	111

Study	Data sources
TRANSCEND	Individual patient data
JULIET	Schuster et al. [8] was supplemented with the EMA Public Assessment Report [33], the EMA Summary of Product Characteristics [34], the United States FDA Summary Basis for Regulatory Action [35], and Schuster et al. [16]d

CR complete response, CRS cytokine release syndrome, DLBCL diffuse large B-cell lymphoma, EOS end of study, EMA European Medicines Agency, FDA Food and Drug Administration, liso-cel lisocabtagene maraleucel, ORR objective response rate, OS overall survival, PFS progression-free survival

^aData cutoffs with most complete data availability were included

^bMedian on-study follow-up time was reported, which was defined as (EOS date—first dose date + 1)/30.4375. If patients were continuing on study, the data cutoff date was used to impute the EOS date for the purpose of the calculation

^cMedian follow-up time from infusion to data cutoff was reported [8]

^dIn JULIET, CRS was rated according to the University of Pennsylvania criteria. However, the JULIET investigators regraded CRS events according to the Lee 2014 criteria [36]; rates of CRS associated with tisagenlecleucel were extracted from Schuster et al. [16], which was based on the Lee 2014 criteria [36] and also used in TRANSCEND