Article ; Online: 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.
Clinical lymphoma, myeloma & leukemia
2022 Volume 22, Issue 9, Page(s) 690–701
Abstract: Introduction: 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 ... ...
Abstract | Introduction: 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. Patients and methods: 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. Results: 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. Conclusion: 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. |
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MeSH term(s) | Antibodies, Monoclonal, Humanized ; Antineoplastic Combined Chemotherapy Protocols/pharmacology ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Dexamethasone/pharmacology ; Dexamethasone/therapeutic use ; Humans ; Hydrazines ; Melphalan/pharmacology ; Melphalan/therapeutic use ; Multiple Myeloma/drug therapy ; Multiple Myeloma/etiology ; Triazoles |
Chemical Substances | Antibodies, Monoclonal, Humanized ; Hydrazines ; Triazoles ; selinexor (31TZ62FO8F) ; Dexamethasone (7S5I7G3JQL) ; belantamab mafodotin (DB1041CXDG) ; Melphalan (Q41OR9510P) |
Language | English |
Publishing date | 2022-05-23 |
Publishing country | United States |
Document type | Clinical Trial ; Journal Article ; Research Support, Non-U.S. Gov't |
ZDB-ID | 2540992-X |
ISSN | 2152-2669 ; 2152-2650 |
ISSN (online) | 2152-2669 |
ISSN | 2152-2650 |
DOI | 10.1016/j.clml.2022.04.025 |
Database | MEDical Literature Analysis and Retrieval System OnLINE |
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