Subgroup analysis of ICARIA-MM study in relapsed/refractory multiple myeloma patients with high-risk cytogenetics.
Abnormal Karyotype
Adult
Aged
Aged, 80 and over
Antibodies, Monoclonal, Humanized
/ administration & dosage
Antineoplastic Agents, Immunological
/ administration & dosage
Chromosomes, Human, Pair 1
/ genetics
Clinical Trials, Phase III as Topic
/ statistics & numerical data
Dexamethasone
/ administration & dosage
Febrile Neutropenia
/ chemically induced
Female
Humans
Immunologic Factors
/ administration & dosage
Kaplan-Meier Estimate
Male
Middle Aged
Multiple Myeloma
/ drug therapy
Myeloma Proteins
/ analysis
Pneumonia
/ chemically induced
Randomized Controlled Trials as Topic
/ statistics & numerical data
Recurrence
Risk
Salvage Therapy
Thalidomide
/ administration & dosage
Trisomy
cytogenetics
gain (1q21)
high-risk
isatuximab
relapsed/refractory multiple myeloma
Journal
British journal of haematology
ISSN: 1365-2141
Titre abrégé: Br J Haematol
Pays: England
ID NLM: 0372544
Informations de publication
Date de publication:
07 2021
07 2021
Historique:
revised:
22
03
2021
received:
15
01
2021
accepted:
30
03
2021
pubmed:
27
5
2021
medline:
17
12
2021
entrez:
26
5
2021
Statut:
ppublish
Résumé
Treatment benefit in multiple myeloma (MM) patients with high-risk cytogenetics remains suboptimal. The phase 3 ICARIA-MM trial (NCT02990338) showed that isatuximab plus pomalidomide-dexamethasone prolongs median progression-free survival (mPFS) in patients with relapsed/refractory MM (RRMM). This subgroup analysis of ICARIA-MM compared the benefit of isatuximab in high-risk [defined by the presence of del(17p), t(4;14) or t(14;16)] versus standard-risk patients. The efficacy of isatuximab in patients with gain(1q21) abnormality was also assessed in a retrospective subgroup analysis. In ICARIA-MM, 307 patients received isatuximab-pomalidomide-dexamethasone (n = 154) or pomalidomide-dexamethasone (n = 153). Isatuximab (10 mg/kg intravenously) was given weekly in the first 28-day cycle, and every other week thereafter. Standard pomalidomide-dexamethasone doses were given. Isatuximab-pomalidomide-dexamethasone improved mPFS (7·5 vs 3·7 months; HR, 0·66; 95% CI, 0·33-1·28) and overall response rate (ORR, 50·0% vs 16·7%) in high-risk patients. In patients with isolated gain(1q21), isatuximab addition improved mPFS (11·2 vs 4·6 months; HR, 0·50; 95% CI, 0·28-0·88) and ORR (53·6% vs 27·6%). More grade ≥3 adverse events occurred in high-risk patients receiving isatuximab (95·7%) versus the control group (67·6%); however, isatuximab did not increase events leading to discontinuation or treatment-related mortality. Isatuximab-pomalidomide-dexamethasone provides a consistent benefit over pomalidomide-dexamethasone treatment in RRMM patients regardless of cytogenetic risk.
Identifiants
pubmed: 34036560
doi: 10.1111/bjh.17499
pmc: PMC8361732
doi:
Substances chimiques
Antibodies, Monoclonal, Humanized
0
Antineoplastic Agents, Immunological
0
Immunologic Factors
0
Myeloma Proteins
0
Thalidomide
4Z8R6ORS6L
Dexamethasone
7S5I7G3JQL
pomalidomide
D2UX06XLB5
isatuximab
R30772KCU0
Types de publication
Comparative Study
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
120-131Informations de copyright
© 2021 The Authors. British Journal of Haematology published by British Society for Haematology and John Wiley & Sons Ltd.
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