Isatuximab-pomalidomide-dexamethasone versus pomalidomide-dexamethasone in patients with relapsed and refractory multiple myeloma: final overall survival analysis
Language English Country Italy Media electronic
Document type Journal Article, Randomized Controlled Trial, Multicenter Study, Clinical Trial, Phase III, Research Support, Non-U.S. Gov't
PubMed
38299578
PubMed Central
PMC11215383
DOI
10.3324/haematol.2023.284325
Knihovny.cz E-resources
- MeSH
- Survival Analysis MeSH
- Drug Resistance, Neoplasm MeSH
- Dexamethasone * administration & dosage MeSH
- Adult MeSH
- Antibodies, Monoclonal, Humanized * administration & dosage therapeutic use MeSH
- Middle Aged MeSH
- Humans MeSH
- Multiple Myeloma * drug therapy mortality pathology MeSH
- Antineoplastic Combined Chemotherapy Protocols * therapeutic use adverse effects MeSH
- Recurrence MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Thalidomide * analogs & derivatives administration & dosage MeSH
- Treatment Outcome MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
- Names of Substances
- Dexamethasone * MeSH
- Antibodies, Monoclonal, Humanized * MeSH
- isatuximab MeSH Browser
- pomalidomide MeSH Browser
- Thalidomide * MeSH
The primary and prespecified updated analyses of ICARIA-MM (clinicaltrial gov. Identifier: NCT02990338) demonstrated improved progression-free survival (PFS) and a benefit in overall survival (OS) was reported with the addition of isatuximab, an anti-CD38 monoclonal antibody, to pomalidomide-dexamethasone (Pd) in patients with relapsed/refractory multiple myeloma. Here, we report the final OS analysis. This multicenter, randomized, open-label, phase III study included patients who had received and failed ≥2 previous therapies, including lenalidomide and a proteasome inhibitor. Between January 10, 2017, and February 2, 2018, 307 patients were randomized (1:1) to isatuximab-pomalidomide-dexamethasone (Isa-Pd; N=154) or Pd (N=153), stratified based on age (<75 vs. ≥75 years) and number of previous lines of therapy (2-3 vs. >3). At data cutoff for the final OS analysis after 220 OS events (January 27, 2022), median follow-up duration was 52.4 months. Median OS was 24.6 months (95% confidence interval [CI]: 20.3-31.3) with Isa-Pd and 17.7 months (95% CI: 14.4- 26.2) with Pd (hazard ratio=0.78; 95% CI: 0.59-1.02; 1-sided P=0.0319). Despite subsequent daratumumab use in the Pd group and its potential benefit on PFS in the first subsequent therapy line, median PFS2 was significantly longer with Isa-Pd versus Pd (17.5 vs. 12.9 months; log-rank 1-sided P=0.0091). In this analysis, Isa-Pd continued to be efficacious and well tolerated after follow-up of approximately 52 months, contributing to a clinically meaningful, 6.9-month improvement in median OS in patients with relapsed/refractory multiple myeloma.
CHU de Toulouse IUCT O Université de Toulouse UPS Service d'Hématologie Toulouse
Clínica Universidad de Navarra Navarra CCUN CIMA IDISNA CIBER ONC Pamplona
Department of Hematology Ankara University Ankara Turkey
Department of Hematology National Taiwan University Hospital Taipei Taiwan
Hematology Department CHU Nantes Nantes
Immunology and Molecular Oncology Epworth Healthcare University of Melbourne Melbourne VIC Australia
Service d'Hématologie et Thérapie Cellulaire CHU and CIC Inserm 1402 Poitiers Cedex
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ClinicalTrials.gov
NCT02990338
