Positive interim results from elotuzumab Phase 1b/2 study in relapsed multiple myeloma

Abbott (NYSE: ABT) and Bristol-Myers Squibb Company (NYSE: BMY) today announced interim results from the Phase 2 portion of a Phase 1b/2 open-label study which showed a high objective response rate (ORR) among patients with relapsed multiple myeloma who received elotuzumab plus lenalidomide and low-dose dexamethasone. ORR, the primary endpoint of the Phase 2 portion of the study, was defined as partial response or better and assessed using International Myeloma Working Group (IMWG) criteria. These results were presented today during an oral session at the 52^nd Annual Meeting of the American Society of Hematology in Orlando.

“There remains a need for more effective and tolerable treatment options for patients with relapsed multiple myeloma, as almost all patients eventually relapse and require further therapy”

Of 31 previously-treated patients who received elotuzumab 10 mg/kg plus lenalidomide and low-dose dexamethasone, 28 (90%) achieved an objective response. Of 32 previously-treated patients who received elotuzumab 20 mg/kg plus lenalidomide and low-dose dexamethasone, 23 (72%) achieved an objective response. The median time to progression-free survival was not reached after 4.9 months of follow-up.

In the study, grade 3 and 4 adverse events included neutropenia (14%), lymphopenia (14%) and thrombocytopenia (13%). The overall rate of treatment-emergent grade 3/4 adverse events was 56%. The overall rate of grade 3/4 elotuzumab-related adverse events was 24%. Of patients with infusion-related reactions, one patient (1.6%) experienced grade 3 rash within 24 hours of treatment with elotuzumab. There were no grade 4 infusion-related adverse events. The most common elotuzumab-related adverse events were fatigue (21%), pyrexia (14%), lymphopenia (11%), nausea (11%) diarrhea (11%), constipation (10%) and neutropenia (10%).

Multiple myeloma is the second most common blood cancer in the United States, with a 5-year survival rate of approximately 35%. Elotuzumab is an investigational humanized monoclonal antibody specifically directed against CS1, a cell-surface glycoprotein that is highly and uniformly present on multiple myeloma cells.

"There remains a need for more effective and tolerable treatment options for patients with relapsed multiple myeloma, as almost all patients eventually relapse and require further therapy," said Paul G. Richardson, M.D. Clinical Director, Jerome Lipper Center for Multiple Myeloma, Dana-Farber Cancer Institute, lead author and investigator on the study. "The preliminary Phase 2 data presented today support further investigation of the potential role of elotuzumab in combination with lenalidomide and low-dose dexamethasone as a treatment option for patients with relapsed multiple myeloma."

A Phase 3 clinical development program for elotuzumab in relapsed multiple myeloma is expected to be initiated in early 2011.