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- Title
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.
- Authors
Dimopoulos, Meletios A.; Lonial, Sagar; White, Darrell; Moreau, Philippe; Palumbo, Antonio; San‐Miguel, Jesus; Shpilberg, Ofer; Anderson, Kenneth; Grosicki, Sebastian; Spicka, Ivan; Walter‐Croneck, Adam; Magen, Hila; Mateos, Maria‐Victoria; Belch, Andrew; Reece, Donna; Beksac, Meral; Bleickardt, Eric; Poulart, Valerie; Sheng, Jennifer; Sy, Oumar
- 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.
- Subjects
MULTIPLE myeloma treatment; MULTIPLE myeloma; DEXAMETHASONE; TREATMENT effectiveness; DISEASE progression; SERUM; PATIENTS
- Publication
British Journal of Haematology, 2017, Vol 178, Issue 6, p896
- ISSN
0007-1048
- Publication type
Article
- DOI
10.1111/bjh.14787