Cited by 1,322Multiple Myeloma Research and TreatmentsMonoclonal and Polyclonal Antibodies ResearchChronic Lymphocytic Leukemia Research

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Elotuzumab Therapy for Relapsed or Refractory Multiple Myeloma

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Lonial, Sagar, Dimopoulos, Meletios, Palumbo, Antonio, White, Darrell, Grosicki, Sebastian, Spicka, Ivan, Walter-Croneck, Adam, Moreau, Philippe, Mateos, Maria-Victoria, Magen, Hila, Belch, Andrew, Reece, Donna, Beksac, Meral, Spencer, Andrew, Oakervee, Heather, Orlowski, Robert Z., Taniwaki, Masafumi, Röllig, Christoph, Einsele, Hermann, Wu, Ka Lung, Singhal, Anil, San-Miguel, Jesus, Matsumoto, Morio, Katz, Jessica, Bleickardt, Eric, Poulart, Valerie, Anderson, Kenneth C., Richardson, Paul·2015·New England Journal of Medicine

DOI 10.1056/nejmoa1505654

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Abstract

BACKGROUND: Elotuzumab, an immunostimulatory monoclonal antibody targeting signaling lymphocytic activation molecule F7 (SLAMF7), showed activity in combination with lenalidomide and dexamethasone in a phase 1b-2 study in patients with relapsed or refractory multiple myeloma. METHODS: In this phase 3 study, we randomly assigned patients to receive either elotuzumab plus lenalidomide and dexamethasone (elotuzumab group) or lenalidomide and dexamethasone alone (control group). Coprimary end points were progression-free survival and the overall response rate. Final results for the coprimary end points are reported on the basis of a planned interim analysis of progression-free survival. RESULTS: Overall, 321 patients were assigned to the elotuzumab group and 325 to the control group. After a median follow-up of 24.5 months, the rate of progression-free survival at 1 year in the elotuzumab group was 68%, as compared with 57% in the control group; at 2 years, the rates were 41% and 27%, respectively. Median progression-free survival in the elotuzumab group was 19.4 months, versus 14.9 months in the control group (hazard ratio for progression or death in the elotuzumab group, 0.70; 95% confidence interval, 0.57 to 0.85; P<0.001). The overall response rate in the elotuzumab group was 79%, versus 66% in the control group (P<0.001). Common grade 3 or 4 adverse events in the two groups were lymphocytopenia, neutropenia, fatigue, and pneumonia. Infusion reactions occurred in 33 patients (10%) in the elotuzumab group and were grade 1 or 2 in 29 patients. CONCLUSIONS: Patients with relapsed or refractory multiple myeloma who received a combination of elotuzumab, lenalidomide, and dexamethasone had a significant relative reduction of 30% in the risk of disease progression or death. (Funded by Bristol-Myers Squibb and AbbVie Biotherapeutics; ELOQUENT-2 ClinicalTrials.gov number, NCT01239797.).

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Authors: Lonial, S., Dimopoulos, M., Palumbo, A., White, D., Grosicki, S., Spicka, I., Walter-Croneck, A., Moreau, P., Mateos, M.-V., Magen, H., Belch, A., Reece, D., Beksac, M., Spencer, A., Oakervee, H., Orlowski, R. Z., Taniwaki, M., Röllig, C., Einsele, H., Wu, K. L., Singhal, A., San-Miguel, J., Matsumoto, M., Katz, J., Bleickardt, E., Poulart, V., Anderson, K. C., & Richardson, P.
Affiliations: Dalhousie University (CA)
National and Kapodistrian University of Athens (GR)
Azienda Ospedaliero Universitaria San Giovanni Battista (IT)
Medical University of Silesia (PL)
Centre Hospitalier Universitaire de Nantes (FR)
Tel Aviv University (IL)
University of Alberta (CA)
Princess Margaret Cancer Centre (CA)
Alfred Health (AU)
Barts Health NHS Trust (GB)
The University of Texas MD Anderson Cancer Center (US)
Kyoto Prefectural University of Medicine (JP)
Technische Universität Dresden (DE)
Universitätsklinikum Würzburg (DE)
Ziekenhuisnetwerk Antwerpen Stuivenberg (BE)
AbbVie Biotherapeutics (United States) (US)
National Hospital Organization (JP)
Bristol-Myers Squibb (United States) (US)
Dana-Farber Cancer Institute (US)
ORCID: Lonial, Sagar
Dimopoulos, Meletios
Palumbo, Antonio
White, Darrell
Grosicki, Sebastian
Moreau, Philippe
Magen, Hila
Belch, Andrew
Reece, Donna
Spencer, Andrew
Orlowski, Robert Z.
Röllig, Christoph
Einsele, Hermann
Wu, Ka Lung
Bleickardt, Eric
Anderson, Kenneth C.
Richardson, Paul
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2015-08-13
Volume: 373
Issue: 7
Pages: 621-631
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa1505654
OpenAlex: W2201190784
Semantic Scholar: fb9d8d9019089b66fbe8ecd85963014c537e649e
Cited by: 1,322
References: 15
Citations by year: 2026: 29 · 2025: 60 · 2024: 63 · 2023: 87 · 2022: 95 · 2021: 147 · 2020: 174 · 2019: 132 · 2018: 154 · 2017: 187 · 2016: 160 · 2015: 33
FWCI: 139.84
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
Institutional Research Information System University of Turin (University of Turin) (submittedVersion, other-oa)
Funders: Bristol-Myers Squibb
AbbVie Biotherapeutics
Topics: Health Sciences › Medicine › Hematology › Multiple Myeloma Research and Treatments
Life Sciences › Immunology and Microbiology › Immunology › Monoclonal and Polyclonal Antibodies Research
Health Sciences › Medicine › Hematology › Chronic Lymphocytic Leukemia Research
Keywords: elotuzumab, relapsed/refractory multiple myeloma, SLAMF7, lenalidomide, dexamethasone, progression-free survival, overall response rate, monoclonal antibodies, combination therapy, adverse events, lymphopenia, neutropenia, infusion reactions, interim analysis, overall survival
MeSH terms: Signaling Lymphocytic Activation Molecule Family, Lenalidomide, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Dexamethasone, Humans, Middle Aged, Multiple Myeloma, Receptors, Immunologic, Recurrence, Thalidomide, Disease-Free Survival, Antibodies, Monoclonal, Humanized

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