TY - JOUR
T1 - Indirect comparison of tisagenlecleucel and historical treatments for relapsed/refractory diffuse large B-cell lymphoma
AU - Maziarz, Richard T.
AU - Zhang, Jie
AU - Yang, Hongbo
AU - Chai, Xinglei
AU - Yuan, Chengbo
AU - Schwarz, Elisabeth
AU - Jakovac, Mihael
AU - Martinez-Prieto, Marcela
AU - Agarwal, Abhijit
AU - Degtyarev, Evgeny
AU - Tam, Constantine
AU - Salles, Gilles
N1 - Funding Information:
Conflict-of-interest disclosure: H.Y., X.C., and C.Y. are employees of Analysis Group, Inc., which has received consulting fees from Novartis Pharmaceuticals for the conduct of this research. J.Z., E.S., M.J., M.M.-P., A.A., and E.D. are employees of Novartis Pharmaceuticals and hold stock/options. C.T. reports honoraria from Janssen, Beigene, AbbVie, and Novartis; and research funding from Janssen, Beigene, and AbbVie. G.S. reports honoraria from Bayer, AbbVie, Epizyme, MorphoSys, and Regeneron; and is a consultant to AbbVie, Beigene, BMS/Celgene, Debiopharm, Epi-zyme, Genentech/Roche, Genmab, Incyte, Janssen, Kite/Gilead, Loxo, Miltenyi, MorphoSys, Novartis, Rapt, Regeneron, Takeda, VelosBio, and Allogene. R.T.M. is an advisor or consultant for Allo-Vir, Artiva, CRISPR Therapeutics, CytoDyn, Incyte, and Novartis; reports honoraria from Bristol Myers Squibb/Celgene, Incyte, Intel-lia, and Kite; research support from BMS, AlloVir, and Novartis; participation in a data and safety monitoring board for Athersys and Novartis; and holds a patent with Athersys.
Publisher Copyright:
© 2022 by The American Society of Hematology.
PY - 2022/4/26
Y1 - 2022/4/26
N2 - 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 5 .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.
AB - 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 5 .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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U2 - 10.1182/bloodadvances.2021006280
DO - 10.1182/bloodadvances.2021006280
M3 - Article
C2 - 35030634
AN - SCOPUS:85129319215
VL - 6
SP - 2536
EP - 2547
JO - Blood advances
JF - Blood advances
SN - 2473-9529
IS - 8
ER -