Interim results from the Phase 2 portion of a Phase 1b/2 open-label study have shown a high objective response rate ( ORR ) among patients with relapsed multiple myeloma who received Elotuzumab plus Lenalidomide and low-dose Dexamethasone.

Objective response rate, 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.

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% ).

Patients were randomized 1:1 to receive Elotuzumab either 10 or 20 mg/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 ), along with Lenalidomide 25 mg PO daily on days 1 to 21 and Dexamethasone 40 mg PO weekly.
Patients were treated until disease progression or unacceptable toxicity, if earlier.
To control potential infusion reactions, patients received Methylprednisolone ( 50 mg IV ), Diphenhydramine ( 25–50 mg PO or IV ) or equivalent, Ranitidine ( 50 mg IV ) or equivalent, and Acetaminophen ( 650–1000 mg PO ) 30 to 60 minutes prior to each Elotuzumab infusion.

Multiple myeloma is the second most common blood cancer in the United States, with a 5-year survival rate of approximately 35%. In 2010, it is estimated that 20,180 new cases will be diagnosed in the U.S. and that 10,650 people will die from the disease.
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.

Source: 52nd Annual Meeting of the American Society of Hematology, 2010

XagenaMedicine2010


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