Elotuzumab, lenalidomide, and dexamethasone in RRMM: final overall survival results from the phase 3 randomized ELOQUENT-2 study
Language English Country United States Media electronic
Document type Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
PubMed
32887873
PubMed Central
PMC7474076
DOI
10.1038/s41408-020-00357-4
PII: 10.1038/s41408-020-00357-4
Knihovny.cz E-resources
- MeSH
- Dexamethasone administration & dosage adverse effects MeSH
- Adult MeSH
- Antibodies, Monoclonal, Humanized administration & dosage adverse effects MeSH
- Lenalidomide administration & dosage adverse effects MeSH
- Middle Aged MeSH
- Humans MeSH
- Survival Rate MeSH
- Multiple Myeloma drug therapy mortality MeSH
- Disease-Free Survival MeSH
- Antineoplastic Combined Chemotherapy Protocols administration & dosage adverse effects MeSH
- Recurrence MeSH
- Aged, 80 and over MeSH
- Aged 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
- elotuzumab MeSH Browser
- Antibodies, Monoclonal, Humanized MeSH
- Lenalidomide MeSH
Prolonging overall survival (OS) remains an unmet need in relapsed or refractory multiple myeloma (RRMM). In ELOQUENT-2 (NCT01239797), elotuzumab plus lenalidomide/dexamethasone (ERd) significantly improved progression-free survival (PFS) versus lenalidomide/dexamethasone (Rd) in patients with RRMM and 1-3 prior lines of therapy (LoTs). We report results from the pre-planned final OS analysis after a minimum follow-up of 70.6 months, the longest reported for an antibody-based triplet in RRMM. Overall, 646 patients with RRMM and 1-3 prior LoTs were randomized 1:1 to ERd or Rd. PFS and overall response rate were co-primary endpoints. OS was a key secondary endpoint, with the final analysis planned after 427 deaths. ERd demonstrated a statistically significant 8.7-month improvement in OS versus Rd (median, 48.3 vs 39.6 months; hazard ratio, 0.82 [95.4% Cl, 0.68-1.00]; P = 0.0408 [less than allotted α of 0.046]), which was consistently observed across key predefined subgroups. No additional safety signals with ERd at extended follow-up were reported. ERd is the first antibody-based triplet regimen shown to significantly prolong OS in patients with RRMM and 1-3 prior LoTs. The magnitude of OS benefit was greatest among patients with adverse prognostic factors, including older age, ISS stage III, IMWG high-risk disease, and 2-3 prior LoTs.
AbbVie Biotherapeutics Redwood City CA USA
Alfred Health Monash University Melbourne VIC Australia
Ankara University Ankara Turkey
Barts Health NHS Trust London UK
Bristol Myers Squibb Company Princeton NJ USA
Charles University Prague and General Teaching Hospital Prague Czech Republic
Cross Cancer Institute and University of Alberta Edmonton AB Canada
Dana Farber Cancer Institute Boston MA USA
Institute of Haematology Assuta Medical Centers Tel Aviv Israel
Kyoto Prefectural University of Medicine Kyoto Japan
Medical University of Lublin Lublin Poland
Medical University of Silesia Katowice Poland
National and Kapodistrian University of Athens School of Medicine Athens Greece
National Hospital Organization Shibukawa Medical Center Shibukawa Japan
Princess Margaret Hospital Toronto ON Canada
Queen Elizabeth 2 Health Sciences Centre and Dalhousie University Halifax NS Canada
The University of Texas MD Anderson Cancer Center Houston TX USA
Universitätsklinikum der Technischen Universität Dresden Germany
Universitätsklinikum Würzburg Würzburg Germany
University Hospital Nantes France
University Medical Center of Hamburg Eppendorf Hamburg Germany
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Monoclonal Antibodies and Antibody Drug Conjugates in Multiple Myeloma
