Matching-Adjusted Indirect Treatment Comparison to Assess the Comparative Efficacy of Ciltacabtagene Autoleucel in CARTITUDE-1 Versus Belantamab Mafodotin in DREAMM-2, Selinexor-Dexamethasone in STORM Part 2, and Melphalan Flufenamide-Dexamethasone in HORIZON for the Treatment of Patients With Triple-Class Exposed Relapsed or Refractory Multiple Myeloma.


Journal

Clinical lymphoma, myeloma & leukemia
ISSN: 2152-2669
Titre abrégé: Clin Lymphoma Myeloma Leuk
Pays: United States
ID NLM: 101525386

Informations de publication

Date de publication:
09 2022
Historique:
received: 03 12 2021
revised: 30 03 2022
accepted: 15 04 2022
pubmed: 29 6 2022
medline: 30 8 2022
entrez: 28 6 2022
Statut: ppublish

Résumé

This study estimated the comparative efficacy of ciltacabtagene autoleucel (cilta-cel; CARTITUDE-1), a chimeric antigen receptor (CAR)-T-cell therapy, versus 3 non-CAR-T therapies (belantamab mafodotin [DREAMM-2], selinexor plus dexamethasone [STORM Part 2], and melphalan flufenamide plus dexamethasone [HORIZON]), each with distinct mechanisms of action, for the treatment of patients with relapsed or refractory multiple myeloma (RRMM) who were triple-class exposed to an immunomodulatory drug, proteasome inhibitor, and an anti-CD38 monoclonal antibody. Pairwise matching-adjusted indirect treatment comparisons (MAICs) were conducted using patient-level data for cilta-cel from CARTITUDE-1 and summary level data for each comparator (2.5 mg/kg cohort in DREAMM-2, modified intention-to-treat population in STORM Part 2, and triple-class refractory patients in HORIZON). Treated patients from CARTITUDE-1 who satisfied the eligibility of the comparator trial were included. MAICs adjusted for imbalances in important prognostic factors between CARTITUDE-1 and the comparator populations. Comparative efficacy of cilta-cel versus each therapy was estimated for overall response rate, complete response or better rate, progression-free survival, and overall survival. After adjustment, patients treated with cilta-cel demonstrated at least a 3.1-fold and at least a 10.3-fold increase in the likelihood of achieving an overall response or complete response or better, respectively, at least a 74% reduction in the risk of disease progression or death, and at least a 47% reduction in the risk of death. These results were statistically significant. Cilta-cel showed improved efficacy over each comparator for all outcomes, demonstrating its potential as an efficacious treatment for patients with triple-class exposed RRMM.

Identifiants

pubmed: 35764490
pii: S2152-2650(22)00164-1
doi: 10.1016/j.clml.2022.04.025
pii:
doi:

Substances chimiques

Antibodies, Monoclonal, Humanized 0
Hydrazines 0
Triazoles 0
selinexor 31TZ62FO8F
Dexamethasone 7S5I7G3JQL
belantamab mafodotin DB1041CXDG
Melphalan Q41OR9510P

Types de publication

Clinical Trial Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

690-701

Informations de copyright

Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.

Auteurs

Katja Weisel (K)

University Medical Center Hamburg-Eppendorf, Hamburg, Germany. Electronic address: k.weisel@uke.de.

Amrita Krishnan (A)

Judy and Bernard Briskin Center for Multiple Myeloma Research, City of Hope, Duarte, CA.

Jordan M Schecter (JM)

Janssen R&D, Raritan, NJ.

Martin Vogel (M)

Janssen Global Services, LLC, Raritan, NJ.

Carolyn C Jackson (CC)

Janssen R&D, Raritan, NJ.

William Deraedt (W)

Janssen R&D, Beerse, Belgium.

Tzu-Min Yeh (TM)

Janssen R&D, Raritan, NJ.

Arnob Banerjee (A)

Janssen R&D, Spring House, PA.

Fevzi Yalniz (F)

Legend Biotech USA, Inc, Piscataway, NJ.

Tonia Nesheiwat (T)

Legend Biotech USA, Inc, Piscataway, NJ.

Suzy Van Sanden (S)

Janssen Pharmaceutica NV, Beerse, Belgium.

Joris Diels (J)

Janssen Pharmaceutica NV, Beerse, Belgium.

Satish Valluri (S)

Janssen Global Services, LLC, Raritan, NJ.

Saad Z Usmani (SZ)

Levine Cancer Institute-Atrium Health, Charlotte, NC.

Jesus G Berdeja (JG)

Sarah Cannon Research Institute, Nashville, TN.

Sundar Jagannath (S)

Mount Sinai Medical Center, New York, NY.

Tom Martin (T)

UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA.

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Classifications MeSH