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Clinical Trial
. 2022 Apr 26;6(8):2536-2547.
doi: 10.1182/bloodadvances.2021006280.

Indirect comparison of tisagenlecleucel and historical treatments for relapsed/refractory diffuse large B-cell lymphoma

Richard T Maziarz  1 , Jie Zhang  2 , Hongbo Yang  3 , Xinglei Chai  3 , Chengbo Yuan  3 , Elisabeth Schwarz  2 , Mihael Jakovac  2 , Marcela Martinez-Prieto  2 , Abhijit Agarwal  2 , Evgeny Degtyarev  2 , Constantine Tam  4 , Gilles Salles  5
Affiliations
Clinical Trial

Indirect comparison of tisagenlecleucel and historical treatments for relapsed/refractory diffuse large B-cell lymphoma

Richard T Maziarz et al. Blood Adv. .

Abstract

No head-to-head trials have compared the efficacy of tisagenlecleucel vs historical treatments for adults with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL). This study indirectly compared the overall survival (OS) and overall response rate (ORR) associated with tisagenlecleucel, using data from the JULIET study (Study of Efficacy and Safety of CTL019 in Adult DLBCL Patients; #NCT02445248), vs historical treatments assessed in the CORAL (Collaborative Trial in Relapsed Aggressive Lymphoma) study follow-up population. To assess treatment effects in the treated (full analysis set [FAS]) and enrolled (intention-to-treat [ITT]) study populations, the JULIET FAS vs the CORAL follow-up FAS and JULIET ITT vs CORAL follow-up ITT populations were separately compared. Propensity score weighting using standardized mortality ratio weight (SMRW) and fine stratification weight (FSW) was used to compare OS and ORR, adjusting for baseline confounders. The results indicated that tisagenlecleucel was associated with a lower hazard of death among the FAS (adjusted hazard ratio [95% confidence interval], both FSW and SMRW, 0.44 [0.32, 0.59]) and ITT populations (FSW, 0.60 [0.44, 0.77]; SMRW, 0.57 [0.44, 0.73]; all, P < .001). Median OS was 12.48 months (JULIET) vs 4.34 to 4.40 months (CORAL) for the FAS, and 8.25 (JULIET) months vs 4.04 to 4.86 (CORAL) months for the ITT populations. Tisagenlecleucel was associated with a significantly higher ORR compared with historical treatments among the FAS (adjusted response rate difference [95% confidence interval], both FSW and SMRW, 36% [22%, 0.48%]; P < .001) and among the ITT populations after SMRW adjustment (11% [0%, 22%]; P = .043). This analysis supports that improved response and OS are achieved in patients with r/r DLBCL treated with tisagenlecleucel compared with those treated with alternative historical treatments.

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Figures

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Graphical abstract
Figure 1.
Figure 1.
Sample selection for the CORAL follow-up FAS and ITT populations. *All patients in CORAL follow-up were assumed to have histologically confirmed DLBCL or transformed lymphoma based on the CORAL studies. †CORAL patients were randomly assigned to receive rituximab-based 2L treatment, although 3 patients did not ultimately receive rituximab in 2L and were excluded in this step. ‡A large proportion of patients in CORAL follow-up did not have an Eastern Cooperative Oncology Group (ECOG) or central nervous system (CNS) assessment; those with a missing/unknown ECOG status or CNS assessment were included in the analyses to preserve the sample size. §The ITT population had N = 205 in both the adjusted and unadjusted analyses.
Figure 2.
Figure 2.
OS of the JULIET FAS vs CORAL follow-up FAS populations. Adjusted analyses using FSW (A) and SMWR (B). *P < .05.
Figure 3.
Figure 3.
OS for the JULIET ITT vs CORAL follow-up ITT populations. Adjusted analyses using FSW (A) and SMWR (B). *P < .05.
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References

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