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

Clínica Universidad de Navarra Centro de Investigación Médica Aplicada IDISNA CIBERONC Pamplona Spain

Cross Cancer Institute and University of Alberta Edmonton AB Canada

Dana Farber Cancer Institute Boston MA USA

Department of Hematology Chaim Sheba Medical Center Ramat Gan Sackler Faculty of Medicine Tel Aviv University Tel Aviv Israel

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 Hospital of Salamanca Instituto de Investigación Biomédica de Salamanca Centro de Investigación del Cáncer IBMCC Salamanca Spain

University Medical Center of Hamburg Eppendorf Hamburg Germany

Winship Cancer Institute Emory University Atlanta GA USA

Ziekenhuis Netwerk Antwerpen Stuivenberg Antwerp Belgium

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