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

Maloney, David G.; Kuruvilla, John; Liu, Fei Fei; Kostic, Ana; Kim, Yeonhee; Bonner, Ashley; Zhang, Yixie; Fox, Christopher P.; Cartron, Guillaume

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


Authors

David G. Maloney

John Kuruvilla

Fei Fei Liu

Ana Kostic

Yeonhee Kim

Ashley Bonner

Yixie Zhang

Guillaume Cartron



Abstract

Background: In the absence of randomized studies directly comparing chimeric antigen receptor T cell therapies, this study used matching-adjusted indirect comparisons (MAIC) to evaluate the comparative efficacy and safety of lisocabtagene maraleucel (liso-cel) versus axicabtagene ciloleucel (axi-cel) in patients with relapsed or refractory large B cell lymphoma (LBCL). Methods: Primary data sources included individual patient data from the TRANSCEND NHL 001 study (TRANSCEND [NCT02631044]; N = 256 for efficacy set, N = 269 for safety set) for liso-cel and summary-level data from the ZUMA-1 study (NCT02348216; N = 101 for efficacy set, N = 108 for safety set) for axi-cel. Inter-study differences in design, eligibility criteria, baseline characteristics, and outcomes were assessed and aligned to the extent feasible. Clinically relevant prognostic factors were adjusted in a stepwise fashion by ranked order. Since bridging therapy was allowed in TRANSCEND but not ZUMA-1, the initial efficacy and safety analyses included bridging therapy use as a matching factor (TRANSCEND patients who received bridging therapy were removed). Subsequent sensitivity analyses excluded this matching factor. Results: The initial analysis showed similar MAIC-weighted efficacy outcomes between TRANSCEND and ZUMA-1 for overall and complete response rates (odds ratio [95% confidence interval (CI)], 1.40 [0.56–3.49] and 1.21 [0.56–2.64], respectively) and for overall survival and progression-free survival (hazard ratio [95% CI], 0.81 [0.44–1.49] and 0.95 [0.58–1.57], respectively). MAIC-weighted safety outcomes favored liso-cel, with significantly lower odds of all-grade and grade ≥ 3 cytokine release syndrome (odds ratio [95% CI], 0.03 [0.01–0.07] and 0.08 [0.01–0.67], respectively) and study-specific neurological events (0.16 [0.08–0.33] and 0.05 [0.02–0.15], respectively). Efficacy and safety outcomes remained similar in sensitivity analyses, which did not include use of bridging therapy as a matching factor. Conclusions: After matching and adjusting for clinically relevant prognostic factors, liso-cel demonstrated comparable efficacy and a more favorable safety profile compared with axi-cel in patients with third- or later-line relapsed or refractory LBCL. Trial registration: NCT02631044 and NCT02348216

Citation

Maloney, D. G., Kuruvilla, J., Liu, F. F., Kostic, A., Kim, Y., Bonner, A., …Cartron, G. (2021). Matching-adjusted indirect treatment comparison of liso-cel versus axi-cel in relapsed or refractory large B cell lymphoma. Journal of Hematology and Oncology, 14(1), Article 140. https://doi.org/10.1186/s13045-021-01144-9

Journal Article Type Article
Acceptance Date Aug 21, 2021
Online Publication Date Sep 8, 2021
Publication Date Sep 8, 2021
Deposit Date Feb 8, 2023
Publicly Available Date Feb 8, 2023
Journal Journal of Hematology & Oncology
Print ISSN 1756-8722
Electronic ISSN 1756-8722
Publisher BioMed Central
Peer Reviewed Peer Reviewed
Volume 14
Issue 1
Article Number 140
DOI https://doi.org/10.1186/s13045-021-01144-9
Keywords Cancer Research; Oncology; Molecular Biology; Hematology
Public URL https://nottingham-repository.worktribe.com/output/17078658
Publisher URL https://jhoonline.biomedcentral.com/articles/10.1186/s13045-021-01144-9

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