TORNA ALL’ELENCO

ELOQUENT-2: Extended safety and efficacy follow-up of the phase 3, randomized, openlabel study of elotuzumab in combination with lenalidomide/dexamethasone in patients with relapsed/refractory multiple myeloma in British Journal of Haematology

2016
AOU Città della Salute di Torino

Tipo pubblicazione

Conference Abstract

Autori/Collaboratori (20)Vedi tutti...

Dimopoulos M

Lonial S

White D


et alii...

Abstract

ELOQUENT-2 is a Phase 3 study (NCT01239797) of elotuzumab plus lenalidomide/dexamethasone (ELd) versus lenalidomide/dexamethasone (Ld) (Lonial et al [2015] N Engl J Med, 373,621). Patients with relapsed/refractory multiple myeloma were randomized 1 : 1 to ELd or Ld in 28-day cycles until disease progression/ unacceptable toxicity. Co-primary endpoints were progression-free survival (PFS) and overall response rate (ORR). Secondary and exploratory endpoints included overall survival (OS) and safety, respectively. Extended follow-up is reported. 646 patients were randomized (ELd 321, Ld 325); median age 66 years (20% ?75 years old); 32% had del(17p); 9% had t(4;14); 35% refractory to last therapy. At database lock (13 August 2015), 26% (ELd) versus 14% (Ld) of patients continued therapy. Discontinuation was mainly due to disease progression (ELd 48%, Ld 51%). ELd had a 27% reduction in the risk of progression/death versus Ld (hazard ratio [HR] 0.73; 95% CI 0.60-0.89; p = 0.0014). 3- year PFS rates were 26% (ELd) versus 18% (Ld). Median (95% CI) PFS was 19.4 (16.6-22.2) months (ELd) versus 14.9 (12.1-17.2) months (Ld). PFS benefit was consistent across key subgroups. ORR was 79% (ELd) versus 66% (Ld). Interim OS HR was 0.77 (95% CI 0.61-0.97; p = 0.0257); median (95% CI) OS was 43.7 (40.3-not estimable [NE]) months (ELd) versus 39.6 (33.3-NE) months (Ld). Median (95% CI) time to next treatment was 33.4 (26.2-40.2) months (ELd) versus 21.2 (18.1-23.2) months (Ld); HR 0.62 (95% CI 0.50-0.77). Grade 3/4 adverse events in ?15% of patients included anaemia (ELd 15%, Ld 16%), neutropaenia (ELd 26%, Ld 33%). Infusion reactions occurred in 10% of ELd-treated patients; most were Grade 1/2, none Grade 4/5. Elotuzumab, plus Ld, demonstrated durable and clinically meaningful improvements in PFS and ORR. Interim OS analysis indicated a trend in favour of ELd. Safety data showed minimal incremental toxicity with the addition of elotuzumab to Ld, consistent with previous re

DOI : 10.1111/bjh.14019

Keywords

prospective study; patient history of transplantation; overall survival; observational study; multiple myeloma; mortality rate; middle aged; medical practice; male; major clinical study; human; human tissue; follow up; gender; female; drug withdrawal; drug therapy; drug combination; controlled study; cohort analysis; short term survival; clinical trial; cardiovascular system; cancer epidemiology; adult; lenalidomide; endogenous compound; bortezomib; staging; tumor resistance;