Data from Phase 2 Study of Elotuzumab in Multiple Myeloma Study Announced
Bristol-Myers Squibb and Abbott announced results from a Phase 2 study of elotuzumab in patients with previously-treated multiple myeloma. Elotuzumab is a humanized monoclonal antibody that enhances immune cell mediated killing of multiple myeloma cells that have the CS1 surface protein.
The primary endpoint of this Phase 2, randomized, multicenter, open-label study was objective response rate (ORR) according to the International Myeloma Working Group (IMWG) response criteria. Patients were randomized 1:1 to receive elotuzumab either 10mg/kg or 20mg/kg (IV infusion on Days 1, 8, 15, and 22 of a 28-day cycle in the first 2 cycles and then Days 1 and 15 of subsequent cycles), with lenalidomide (Revlimid; Celgene) 25mg orally daily on Days 1–21 and dexamethasone 40 mg orally weekly. Patients were treated until disease progression or unacceptable toxicity, if earlier.
In the 10mg/kg arm, median progression-free survival (PFS), or the time without disease progression or death, was not reached after 20.8 months of follow up (N=36) and the ORR was 92%. Of patients who received elotuzumab at a dose of 20mg/kg, median PFS was 18.6 months (N=37) and ORR was 76%.