Bristol-Myers Squibb Company and AbbVie have announced results from an interim analysis of the Phase III ELOQUENT-2 trial.
The trial evaluated elotuzumab in combination with lenalidomide and dexamethasone (ELd) versus lenalidomide and dexamethasone alone (Ld) for the treatment of relapsed or refractory multiple myeloma. The study met its co-primary endpoints demonstrating superior progression-free survival (PFS) and overall response rate (ORR).
The ELd arm demonstrated a 30% reduction in the risk of disease progression or death compared to the Ld arm. The PFS rates in the ELd arm versus the Ld arm were 68% versus 57% at 1 year and 41% versus 27% at 2 years, respectively. A significant ORR also was observed with 79% in the ELd arm compared to 66% in the Ld arm. The safety profile was consistent with previously-reported studies and there were minimal incremental adverse events (AEs) with the addition of elotuzumab to lenalidomide and dexamethasone.
Adding elotuzumab to the standard treatment yielded an impressive reduction in the risk of disease progression
“Despite advances in treatment, multiple myeloma remains a largely incurable disease,” said lead author Sagar Lonial, M.D., chief medical officer of the Winship Cancer Institute of Emory University School of Medicine. “These ELOQUENT-2 data are significant because they show that adding elotuzumab to the standard treatment yielded an impressive reduction in the risk of disease progression, which was maintained over time, demonstrating the benefit of an immune-based approach in multiple myeloma.”
Results from the ELOQUENT-2 trial were presented at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.
Also presented in a poster session at ASCO were results from the Phase II study that evaluated elotuzumab in combination with bortezomib and dexamethasone (EBd) versus bortezomib and dexamethasone (Bd) alone in patients with relapsed or refractory multiple myeloma. Consistent with data from ELOQUENT-2, results from the Phase II study demonstrated a 28% reduction in the risk for disease progression or death in the EBd arm compared to Bd alone. One-year PFS rates were 39% for EBd versus 33% for Bd. One-year survival rates were 85% in the EBd arm versus 74% in the Bd arm.
“These trials, which evaluated elotuzumab in combination with either an IMiD or a proteasome inhibitor, demonstrated that elotuzumab, an immunostimulatory antibody, has the potential to be a new modality for the treatment of multiple myeloma,” said Michael Giordano, senior vice president, Head of Development, Oncology, Bristol-Myers Squibb. “Bristol-Myers Squibb continues to make great progress toward delivering on our commitment to expand the role of immunotherapy into hematologic malignancies, such as multiple myeloma. We look forward to continued follow-up of the ELOQUENT-2 trial as we know improvement in long-term outcomes, including survival, is critical for patients.”
Multiple myeloma is a blood cancer that develops in the bone marrow. It occurs when a plasma cell, a type of cell in the soft centre of bone marrow, becomes cancerous and multiplies uncontrollably. Despite advances in multiple myeloma treatment over the last decade, only 45% of patients have a 5-year survival rate. It is estimated that annually, more than 114,200 new cases of multiple myeloma are diagnosed and more than 79,000 people die from the disease globally.
