- ELOQUENT-2 trial, the open-label phase III study randomised 646 patients with relapsed/refractory multiple myeloma to elotuzumab in combination with lenalidomide and dexamethasone (ERd) (n = 321) or to lenalidomide and dexamethasone alone (Rd) (n = 325)
- ELOQUENT-2 extended follow-up analysis of elotuzumab-based-combination demonstrated an overall 27% reduction in the risk of disease progression or death compared to Rd alone (HR 0.73; 95% CI: 0.60, 0.89; p=0.0014), therefore providing a 44% relative improvement in progression-free survival at three yearsi
- Elotuzumab combination had a median delay of one year to next treatment, compared to Rd alone (HR 0.62; 95% CI: 0.50, 0.77)i
- Pre-specified interim analysis for overall survival found a positive trend favouring the elotuzumab combination versus Rd alone (HR 0.77; 95% CI: 0.61, 0.97; 98.6% CI 0.58, 1.03; p=0.0257)i
Bristol-Myers Squibb Company and AbbVie have announced extended follow-up data and a pre-specified interim overall survival (OS) analysis of elotuzumab in combination with lenalidomide and dexamethasone (ERd) in adult patients with relapsed or refractory multiple myeloma from ELOQUENT-2.i The Phase III data presented at the 57th American Society of Hematology (ASH) Annual Meeting and Exposition in Orlando, demonstrated that elotuzumab in combination with Rd had an improvement in progression-free survival (PFS) with a hazard ratio (HR) of 0.73 (95% CI: 0.60, 0.89; p=0.0014), versus Rd alone.i Updated safety and tolerability data were consistent with previous findings.i Elotuzumab is an investigational treatment not yet licenced for use in Europe.ii
"These elotuzumab data are very encouraging and show an efficacy benefit lasting up to three years in some patients, enabling them to increase the time their disease can be under control." said Professor Graham Jackson, Professor of Clinical Haematology and Clinical Lead for Myeloma at Newcastle Hospitals Trust. "Despite previous advances in treatment, multiple myeloma remains an incurable cancer and it is essential that we benefit from more effective, novel, treatment combinations to delay the progression of this relentless disease. Elotuzumab uses a new approach in the treatment of multiple myeloma by directly activating the body's immune system. It is our hope that elotuzumab-based therapy could provide a new treatment option for UK multiple myeloma patients in the future."
Elotuzumab is a first-in-class monoclonal antibody which acts by reactivating the immune system to target myeloma cells.iii Elotuzumab, incombination with Rd, was shown to delay the need for subsequent myeloma therapy by a median of one year compared to Rd alone.i A pre-specified interim analysis of OS also found a positive trend favouring the elotuzumab combination versus Rd alone (HR 0.77; 95% CI: 0.61, 0.97; 98.6% CI: 0.58, 1.03}; p=0.0257]), though at the time of the interim analysis the OS endpoint had not reached the pre-determined threshold for statistical significance.i Patients will continue to be followed for survival. Common Grade 3 or 4 adverse events included neutropenia (26%), anaemia (15%), fatigue (9%), and diarrhoea (5%).i
Myeloma UK Chief Executive Eric Low said "This eagerly anticipated data for elotuzumab, provides a huge amount of hope for myeloma patients and their families. In the UK, nearly 5000 people each year are diagnosed with myeloma, a complex and debilitating cancer which becomes progressively more serious with each relapse. Myeloma is relapsing and remitting and has no cure, therefore patients need reassurance that there will be other, newer, treatment combinations available to them when their myeloma inevitably relapses."
In July 2015, the European Medicines Agency accepted the request for accelerated assessment of elotuzumab in combination with Rd for the treatment of multiple myeloma in patients who have received one or more prior therapies.iii In the European Union (EU), elotuzumab has also previously obtained orphan drug designation.iv Additionally, elotuzumab as combination therapy with Rd, was approved by the U.S. Food and Drug Administration on 30 November 2015, for the treatment of patients with multiple myeloma who have received one to three prior therapies.v
"The extended follow-up and overall survival data presented at ASH for our immunostimulatory antibody, elotuzumab, reinforce our commitment to helping improve outcomes for patients with multiple myeloma," said Michael Giordano, M.D., senior vice president, head of Development, Oncology, Bristol-Myers Squibb. "These data further demonstrate elotuzumab as combination therapy provides improved efficacy compared to lenalidomide and dexamethasone alone."