Bristol-Myers Squibb Company (NYSE: BMY) and AbbVie (NYSE: ABBV) today announced updated efficacy and safety data from a small, randomized Phase 2, open-label study in patients with previously-treated multiple myeloma that evaluated two doses of the investigational monoclonal antibody elotuzumab (10 mg/kg and 20 mg/kg) in combination with lenalidomide and low-dose dexamethasone. In the 10 mg/kg arm (N=36), which is the dose used in the ongoing Phase 3 trials, median progression-free survival (PFS), or the time without disease progression, was 33 months after a median follow-up of 20.8 months (95% CI: 14.9-NA) and the objective response rate (ORR) was 92%. As previously reported, median PFS was 18 months in the 20 mg/kg arm (N=37) after a median follow-up of 17.1 months (95% CI: 12.912-32.361) and ORR was 76%.
The safety data were consistent with previously-reported results for elotuzumab from this trial. In patients receiving elotuzumab 10 mg/kg or 20 mg/kg, most treatment-emergent adverse events occurred within 18 months of initiating therapy. The most common Grade 3/4 adverse events (seen in > 5% of patients) for the 10 mg/kg and 20 mg/kg arms respectively were lymphopenia (26% and 9%), neutropenia (21% and 22%), thrombocytopenia (21% and 17%), anemia (13% and 12%), leukopenia (8% and 7%), hyperglycemia (5% and 12%), pneumonia (8% and 5%), diarrhea (10% and 5 %), fatigue (8% and 9%), and hypokalemia (8% and 5%). As previously reported at the 2012 American Society of Hematology annual meeting, two deaths occurred on study (multiple adverse events [n=1; pneumonia, multiple organ failure and sepsis]).
These data were presented today at the 18 th Annual Congress of the European Hematology Association (EHA) in Stockholm, Sweden. (Abstract #14)
“There remains a high unmet medical need for patients with multiple myeloma, the second most common blood cancer, as many may relapse and stop responding to currently available treatments,” said Thierry Facon, MD, Hospital Claude Huriez, Service des Maladies du Sang, Lille, France. “The Phase 2 data on elotuzumab are encouraging and support further evaluation in Phase 3 trials.”