Elotuzumab plus Lenalidomide/Dexamethasone in Patients with Relapsed/Refractory MM: ELOQUENT-2 Trial Update

Conference Correspondent  - Conference Correspondent, ASH

Interim analysis of the ELOQUENT-2 trial, a randomized, open-label phase 3 study that evaluated the safety and efficacy of combination therapy with the anti–Signaling Lymphocytic Activation Molecule F7 (SLAMF7) monoclonal antibody elotuzumab plus lenalidomide/dexamethasone (ELd) versus lenalidomide/dexamethasone (Ld) in patients with relapsed/refractory multiple myeloma (MM), had previously demonstrated significant improvements in progression-free survival (PFS) and overall response rate1; the extended 3-year follow-up results of this trial were reported by Dimopoulos and colleagues.2 A total of 646 patients with relapsed/refractory MM were randomized to receive ELd (n = 321) or Ld (n = 325). Del(17p) was observed in 32% of patients in each arm, and refractoriness to the most recent line of therapy was observed in 35% of patients in each arm. This 3-year follow-up analysis showed that ELd therapy was associated with a significant prolongation of PFS compared with Ld therapy (26% vs 18%; hazard ratio, 0.70; P = .0004). Consistently, ELd therapy resulted in a significantly higher overall response rate (79% vs 66%; P = .0002) compared with Ld therapy. Consistent improvement in PFS and overall survival was observed with ELd versus Ld across all predefined subgroups, including those with unfavorable cytogenetics. Grade 3/4 adverse events in the ELd-treated and Ld-treated cohorts included lymphopenia (78% vs 49%), neutropenia (26% vs 33%), anemia (15% vs 16%), and thrombocytopenia (21% vs 20%). High rates of infections (any grade) were reported in both arms (83% vs 75%); exposure-adjusted infection rates were found to be comparable (196 vs 193). Post hoc analyses assessing patient-reported worst pain found that responding patients achieved sustained worst pain improvements and that a higher proportion of patients in the ELd cohort achieved pain improvement compared with control (74 vs 56 patients). Based on these updated 3-year efficacy and safety results of the ELOQUENT-2 study, the authors concluded that incorporation of elotuzumab into the Ld backbone yields sustained improvements in efficacy outcomes without aggravating toxicities. Based largely on the strength of these data, elotuzumab in combination with lenalidomide and dexamethasone was approved on November 30, 2015, by the US Food and Drug Administration for patients with MM who have received 1 to 3 prior therapies.

  1. Lonial S, et al. N Engl J Med. 2015;373:621-631.
  2. Dimopoulos M, et al. ASH 2015. Abstract 28.
Related Items
No Link between Long-Term Eltrombopag Treatment and Incidence of Cataracts in Adult Patients with Chronic ITP During EXTEND
Conference Correspondent  published on December 27, 2017 in ASH
Eltrombopag Treatment Improved Platelet Counts in Patients with Persistent or Chronic ITP
Conference Correspondent  published on December 27, 2017 in ASH
Fostamatinib-Treated Patients with Persistent/Chronic ITP Maintained Long-Term Responses
Conference Correspondent  published on December 27, 2017 in ASH
Avatrombopag Superior to Placebo for the Treatment of Chronic ITP
Conference Correspondent  published on December 27, 2017 in ASH
Subcutaneous Romiplostim Increased Platelet Response in Children with ITP
Conference Correspondent  published on December 27, 2017 in ASH
Centers for Disease Control and Prevention Guidelines on Opioid Use for Cancer Pain
Chase Doyle
TOP - August 2017, Vol 10, No 3 published on August 1, 2017 in Conference Correspondent, HOPA
Maintenance Chemotherapy After Hematopoietic Stem-Cell Transplantation
Chase Doyle
TOP - August 2017, Vol 10, No 3 published on August 1, 2017 in Conference Correspondent, HOPA
Graft-versus-Host Disease: Breakthroughs on the Horizon
Chase Doyle
TOP - August 2017, Vol 10, No 3 published on August 1, 2017 in Conference Correspondent, HOPA
Basket Clinical Trials: A New Era in Cancer Treatment
Chase Doyle
TOP - August 2017, Vol 10, No 3 published on August 1, 2017 in Conference Correspondent, HOPA
Burnout Rates High for Pharmacists in Hematopoietic Stem-Cell Transplantation
Chase Doyle
TOP - August 2017, Vol 10, No 3 published on August 1, 2017 in Conference Correspondent, HOPA
Last modified: December 5, 2017