Bristol-Myers Squibb Company (BMY) and AbbVie Inc. (ABBV) detailed an updated efficacy and safety data of the investigational monoclonal antibody elotuzumab in combination with lenalidomide and low-dose dexamethasone in patients with previously-treated multiple myeloma.
The small, randomized Phase 2, open-label study in patients with previously-treated multiple myeloma evaluated two doses of the combination. The 10 mg/kg arm showed median progression-free survival (PFS), or the time without disease progression, of 33 months after a median follow-up of 20.8 months with an objective response rate of 92 percent. The study had previously reported, median PFS of 18 months in the 20 mg/kg arm after a median follow-up of 17.1 months with an objective response rate of 76 percent.
Thierry Facon, MD, Hospital Claude Huriez, Service des Maladies du Sang, Lille, France, observed, "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."
Dr. Facon added, "The Phase 2 data on elotuzumab are encouraging and support further evaluation in Phase 3 trials."
The safety data was consistent with previously-reported results for elotuzumab from this trial. Patients receiving elotuzumab 10 mg/kg or 20 mg/kg, most treatment-emergent adverse events occurred within 18 months of beginning therapy. The most common Grade 3/4 adverse events seen in less than 5 percent of patients for both doses were lymphopenia, neutropenia, thrombocytopenia, anemia, leukopenia, hyperglycemia, pneumonia, diarrhea, fatigue, and hypokalemia.
As previously reported, two deaths occurred on study with multiple adverse events - pneumonia, multiple organ failure and sepsis.
BMY closed Friday at $46.97, up $0.17 or 0.37%, on a volume of 7.54 million shares on the NYSE. AbbVie last traded at $43.21, up $0.06 or 0.14%, on a volume of 4.07 million shares, also on the NYSE.
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