Multiple myeloma is the second most common blood cancer and remains incurable despite advances in treatment options over the last decade. In fact, there remains a high unmet medical need for patients, as almost all will eventually relapse and become refractory to currently available therapies.

Bristol-Myers Squibb and Abbott have announced results from a small, randomized phase 2, open-label study in patients with previously-treated multiple myeloma that evaluated two doses of Elotuzumab ( 10 mg/kg and 20 mg/kg ) in combination with Lenalidomide and low-dose Dexamethasone. In the 10 mg/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 objective response rate ( ORR ) was 92%. Of patients who received Elotuzumab at a dose of 20 mg/kg, median PFS was 18.6 months ( n=37 ) and ORR was 76%.

The safety data are consistent with previously-reported results for Elotuzumab. Overall, 78% of patients experienced greater than or equal to 1 treatment emergent grade greater than or equal to 3 events.
The most common were lymphopenia ( 19% ), neutropenia ( 18% ), thrombocytopenia ( 16% ), anemia ( 12% ), leukopenia ( 10% ), hyperglycemia ( 10% ), pneumonia ( 7% ), diarrhea ( 7% ), fatigue ( 7% ), and hypokalemia ( 6% ).
Two deaths occurred on study ( multiple adverse events [ n=1; pneumonia, multiple organ failure and sepsis ]; disease progression [ n=1 ] ).
Infusion reactions ( any grade ) were reported in 14% of patients.
Second primary malignancies were reported in four patients and were deemed as unrelated to Elotuzumab.

These results were presented at the 54th Annual Meeting of the American Society of Hematology ( ASH ) in Atlanta.
Elotuzumab, an investigational immunotherapy, is a humanized monoclonal antibody that enhances immune cell mediated killing of multiple myeloma cells that have a surface protein called CS1.

Multiple myeloma is a type of cancer that originates in the white blood cells. It is the second most common blood cancer with an annual incidence of more than 100,000 worldwide and a 5-year survival rate of 41% in newly-diagnosed patients. In 2012, it is estimated that more than 21,700 new cases will be diagnosed in the U.S. and that 10,710 people will die from the disease.

Source: BMS and Abbott, 2012

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