Elotuzumab plus lenalidomide/dexamethasone for relapsed or refractory multiple myeloma: ELOQUENT-2 follow-up and post-hoc analyses on progression-free survival and tumour growth

• Type of Material: Article
• Authors: Meletios A. Dimopoulos, University of Athens; Sagar Lonial, Emory University; Darrell White, Dalhousie University; Philippe Moreau, University Hospital; Antonio Palumbo, University of Torino; Jesus San-Miguel, Clinica Universidad de Navarra; Ofer Shpilberg, Assuta Medical Centers; Kenneth Anderson, Dana‐Farber Cancer Institute; Sebastian Grosicki, Medical University of Silesia; Ivan Spicka, Charles University; Adam Walter-Croneck, Medical University of Lublin; Hila Magen, Rabin Medical Center; Maria‐Victoria Mateos, Instituto de Investigación Biomédica de Salamanca; Andrew Belch, University of Alberta; Donna Reece, Princess Margaret Cancer Centre; Meral Beksac, Ankara University; Eric Bleickardt, Bristol-Myers Squibb; Valerie Poulart, Bristol-Myers Squibb; Jennifer Sheng, Bristol-Myers Squibb; Oumar Sy, Bristol-Myers Squibb; Jessica Katz, Bristol-Myers Squibb; Anil Singhal, AbbVie Biotherapeut Inc; Paul Richardson, Dana‐Farber Cancer Institute
• Language: English
• Date: 2017-09-01
• Publisher: Wiley: 12 months
• Publication Version: Final Published Version
• Copyright Statement: © 2017 John Wiley & Sons Ltd
• License: Creative Commons Attribution-NonCommercial 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1111/bjh.14787
• Title of Journal or Parent Work: British Journal of Haematology
• ISSN: 0007-1048
• Volume: 178
• Issue: 6
• Start Page: 896
• End Page: 905
• Grant/Funding Information: This study was funded by Bristol-Myers Squibb in collaboration with AbbVie Biotherapeutics.
• Keywords: multiple myeloma; DEXAMETHASONE; Hematology; CS1; elotuzumab; monoclonal antibody; overall survival; LENALIDOMIDE; Science & Technology; Life Sciences & Biomedicine; THERAPY; RESPONSE CRITERIA; progression-free survival
• Research Categories: Health Sciences, Oncology; Health Sciences, Medicine and Surgery

Abstract

The randomized phase III ELOQUENT-2 study (NCT01239797) evaluated the efficacy and safety of elotuzumab + lenalidomide/dexamethasone (ELd) versus lenalidomide/dexamethasone (Ld) in relapsed/refractory multiple myeloma. ELd reduced the risk of disease progression/death by 30% versus Ld (hazard ratio [HR] 0·70). Median time from diagnosis was 3·5 years. We present extended 3-year follow-up data. Endpoints included progression-free survival (PFS), overall response rate (ORR) and interim overall survival (OS). Exploratory post-hoc analyses included impact of time from diagnosis and prior lines of therapy on PFS, and serum M-protein dynamic modelling. ORR was 79% (ELd) and 66% (Ld) (P = 0·0002). ELd reduced the risk of disease progression/death by 27% versus Ld (HR 0·73; P = 0·0014). Interim OS demonstrated a trend in favour of ELd (P = 0·0257); 1-, 2- and 3-year rates with ELd versus Ld were: 91% versus 83%, 73% versus 69% and 60% versus 53%. In patients with ≥ median time from diagnosis and one prior therapy, ELd resulted in a 53% reduction in the risk of progression/death versus Ld (HR 0·47). Serum M-protein dynamic modelling showed slower tumour regrowth with ELd. Adverse events were comparable between arms. ELd provided a durable and clinically relevant improvement in efficacy, with minimal incremental toxicity.