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Bristol-Myers Squibb Co and Abbott Laboratories Announce Elotuzumab Progression-Free Survival Data from Phase 2 Study of Patients with Previously-Treated Multiple Myeloma

Sunday, 9 Dec 2012 04:30pm EST 

Bristol-Myers Squibb Co and Abbott Laboratories 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 ≥1 treatment emergent grade ≥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.