Indirect treatment comparison of brexucabtagene autoleucel (ZUMA-2) versus standard of care (SCHOLAR-2) in relapsed/refractory mantle cell lymphoma (2024)

Abstract

The SCHOLAR-2 retrospective study highlighted poor overall survival (OS) with standard of care (SOC) regimens among patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL) who failed a covalent Bruton tyrosine kinase inhibitor (BTKi). In the ZUMA-2 single-arm trial, brexucabtagene autoleucel (brexu-cel; autologous anti-CD19 CAR T-cell therapy) demonstrated high rates of durable responses in patients with R/R MCL who had previous BTKi exposure. Here, we compared OS in ZUMA-2 and SCHOLAR-2 using three different methods which adjusted for imbalances in prognostic factors between populations: inverse probability weighting (IPW), regression adjustment (RA), and doubly robust (DR). Brexu-cel was associated with improved OS compared to SOC across all unadjusted and adjusted comparisons. Hazard ratios (95% confidence intervals) were 0.38 (0.23, 0.61) for IPW, 0.45 (0.28, 0.74) for RA, and 0.37 (0.23, 0.59) for DR. These results suggest a substantial survival benefit with brexu-cel versus SOC in patients with R/R MCL after BTKi exposure.

Original languageEnglish
Pages (from-to)14-25
Number of pages12
JournalLeukemia and Lymphoma
Volume65
Issue number1
Early online date16 Oct 2023
DOIs
Publication statusPublished - 1 Jan 2024

Keywords

  • brexucabtagene autoleucel
  • CAR T-cell therapy
  • indirect treatment comparison
  • mantle cell lymphoma
  • non-Hodgkin lymphoma
  • standard of care

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This output contributes to the following UN Sustainable Development Goals (SDGs)

  • Indirect treatment comparison of brexucabtagene autoleucel (ZUMA-2) versus standard of care (SCHOLAR-2) in relapsed/refractory mantle cell lymphoma (1)

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Hess, G., Dreyling, M., Oberic, L., Gine, E., Zinzani, P. L., Linton, K., Vilmar, A., Jerkeman, M., Chen, J. M. H., Ohler, A., Stilgenbauer, S., Thieblemont, C., Lambert, J., Zilioli, V. R., Sancho, J. M., Jimenez-Ubieto, A., Fischer, L., Eyre, T. A., Keeping, S., ... Salles, G. (2024). Indirect treatment comparison of brexucabtagene autoleucel (ZUMA-2) versus standard of care (SCHOLAR-2) in relapsed/refractory mantle cell lymphoma. Leukemia and Lymphoma, 65(1), 14-25. https://doi.org/10.1080/10428194.2023.2268228

Hess, Georg ; Dreyling, Martin ; Oberic, Lucie et al. / Indirect treatment comparison of brexucabtagene autoleucel (ZUMA-2) versus standard of care (SCHOLAR-2) in relapsed/refractory mantle cell lymphoma. In: Leukemia and Lymphoma. 2024 ; Vol. 65, No. 1. pp. 14-25.

@article{727ccf63bee4455b884859d21916a07f,

title = "Indirect treatment comparison of brexucabtagene autoleucel (ZUMA-2) versus standard of care (SCHOLAR-2) in relapsed/refractory mantle cell lymphoma",

abstract = "The SCHOLAR-2 retrospective study highlighted poor overall survival (OS) with standard of care (SOC) regimens among patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL) who failed a covalent Bruton tyrosine kinase inhibitor (BTKi). In the ZUMA-2 single-arm trial, brexucabtagene autoleucel (brexu-cel; autologous anti-CD19 CAR T-cell therapy) demonstrated high rates of durable responses in patients with R/R MCL who had previous BTKi exposure. Here, we compared OS in ZUMA-2 and SCHOLAR-2 using three different methods which adjusted for imbalances in prognostic factors between populations: inverse probability weighting (IPW), regression adjustment (RA), and doubly robust (DR). Brexu-cel was associated with improved OS compared to SOC across all unadjusted and adjusted comparisons. Hazard ratios (95% confidence intervals) were 0.38 (0.23, 0.61) for IPW, 0.45 (0.28, 0.74) for RA, and 0.37 (0.23, 0.59) for DR. These results suggest a substantial survival benefit with brexu-cel versus SOC in patients with R/R MCL after BTKi exposure.",

keywords = "brexucabtagene autoleucel, CAR T-cell therapy, indirect treatment comparison, mantle cell lymphoma, non-Hodgkin lymphoma, standard of care",

author = "Georg Hess and Martin Dreyling and Lucie Oberic and Eva Gine and Zinzani, {Pier Luigi} and Kim Linton and Adam Vilmar and Mats Jerkeman and Chen, {Jenny M.H.} and Anke Ohler and Stephan Stilgenbauer and Catherine Thieblemont and Jonathan Lambert and Zilioli, {Vittorio Ruggero} and Sancho, {Juan Manuel} and Ana Jimenez-Ubieto and Luca Fischer and Eyre, {Toby A.} and Sam Keeping and Park, {Julie E.} and Wu, {James J.} and Ana Nunes and John Reitan and Wade, {Sally W.} and Gilles Salles",

note = "Publisher Copyright: {\textcopyright} 2023 Kite Pharma. Published by Informa UK Limited, trading as Taylor & Francis Group.",

year = "2024",

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doi = "10.1080/10428194.2023.2268228",

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Hess, G, Dreyling, M, Oberic, L, Gine, E, Zinzani, PL, Linton, K, Vilmar, A, Jerkeman, M, Chen, JMH, Ohler, A, Stilgenbauer, S, Thieblemont, C, Lambert, J, Zilioli, VR, Sancho, JM, Jimenez-Ubieto, A, Fischer, L, Eyre, TA, Keeping, S, Park, JE, Wu, JJ, Nunes, A, Reitan, J, Wade, SW & Salles, G 2024, 'Indirect treatment comparison of brexucabtagene autoleucel (ZUMA-2) versus standard of care (SCHOLAR-2) in relapsed/refractory mantle cell lymphoma', Leukemia and Lymphoma, vol. 65, no. 1, pp. 14-25. https://doi.org/10.1080/10428194.2023.2268228

Indirect treatment comparison of brexucabtagene autoleucel (ZUMA-2) versus standard of care (SCHOLAR-2) in relapsed/refractory mantle cell lymphoma. / Hess, Georg; Dreyling, Martin; Oberic, Lucie et al.
In: Leukemia and Lymphoma, Vol. 65, No. 1, 01.01.2024, p. 14-25.

Research output: Contribution to journalArticlepeer-review

TY - JOUR

T1 - Indirect treatment comparison of brexucabtagene autoleucel (ZUMA-2) versus standard of care (SCHOLAR-2) in relapsed/refractory mantle cell lymphoma

AU - Hess, Georg

AU - Dreyling, Martin

AU - Oberic, Lucie

AU - Gine, Eva

AU - Zinzani, Pier Luigi

AU - Linton, Kim

AU - Vilmar, Adam

AU - Jerkeman, Mats

AU - Chen, Jenny M.H.

AU - Ohler, Anke

AU - Stilgenbauer, Stephan

AU - Thieblemont, Catherine

AU - Lambert, Jonathan

AU - Zilioli, Vittorio Ruggero

AU - Sancho, Juan Manuel

AU - Jimenez-Ubieto, Ana

AU - Fischer, Luca

AU - Eyre, Toby A.

AU - Keeping, Sam

AU - Park, Julie E.

AU - Wu, James J.

AU - Nunes, Ana

AU - Reitan, John

AU - Wade, Sally W.

AU - Salles, Gilles

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PY - 2024/1/1

Y1 - 2024/1/1

N2 - The SCHOLAR-2 retrospective study highlighted poor overall survival (OS) with standard of care (SOC) regimens among patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL) who failed a covalent Bruton tyrosine kinase inhibitor (BTKi). In the ZUMA-2 single-arm trial, brexucabtagene autoleucel (brexu-cel; autologous anti-CD19 CAR T-cell therapy) demonstrated high rates of durable responses in patients with R/R MCL who had previous BTKi exposure. Here, we compared OS in ZUMA-2 and SCHOLAR-2 using three different methods which adjusted for imbalances in prognostic factors between populations: inverse probability weighting (IPW), regression adjustment (RA), and doubly robust (DR). Brexu-cel was associated with improved OS compared to SOC across all unadjusted and adjusted comparisons. Hazard ratios (95% confidence intervals) were 0.38 (0.23, 0.61) for IPW, 0.45 (0.28, 0.74) for RA, and 0.37 (0.23, 0.59) for DR. These results suggest a substantial survival benefit with brexu-cel versus SOC in patients with R/R MCL after BTKi exposure.

AB - The SCHOLAR-2 retrospective study highlighted poor overall survival (OS) with standard of care (SOC) regimens among patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL) who failed a covalent Bruton tyrosine kinase inhibitor (BTKi). In the ZUMA-2 single-arm trial, brexucabtagene autoleucel (brexu-cel; autologous anti-CD19 CAR T-cell therapy) demonstrated high rates of durable responses in patients with R/R MCL who had previous BTKi exposure. Here, we compared OS in ZUMA-2 and SCHOLAR-2 using three different methods which adjusted for imbalances in prognostic factors between populations: inverse probability weighting (IPW), regression adjustment (RA), and doubly robust (DR). Brexu-cel was associated with improved OS compared to SOC across all unadjusted and adjusted comparisons. Hazard ratios (95% confidence intervals) were 0.38 (0.23, 0.61) for IPW, 0.45 (0.28, 0.74) for RA, and 0.37 (0.23, 0.59) for DR. These results suggest a substantial survival benefit with brexu-cel versus SOC in patients with R/R MCL after BTKi exposure.

KW - brexucabtagene autoleucel

KW - CAR T-cell therapy

KW - indirect treatment comparison

KW - mantle cell lymphoma

KW - non-Hodgkin lymphoma

KW - standard of care

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U2 - 10.1080/10428194.2023.2268228

DO - 10.1080/10428194.2023.2268228

M3 - Article

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AN - SCOPUS:85174242231

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JO - Leukemia and Lymphoma

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IS - 1

ER -

Hess G, Dreyling M, Oberic L, Gine E, Zinzani PL, Linton K et al. Indirect treatment comparison of brexucabtagene autoleucel (ZUMA-2) versus standard of care (SCHOLAR-2) in relapsed/refractory mantle cell lymphoma. Leukemia and Lymphoma. 2024 Jan 1;65(1):14-25. Epub 2023 Oct 16. doi: 10.1080/10428194.2023.2268228

Indirect treatment comparison of brexucabtagene autoleucel (ZUMA-2) versus standard of care (SCHOLAR-2) in relapsed/refractory mantle cell lymphoma (2024)
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