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.”
About the Phase 2 StudyIn the phase 2 study, patients with relapsed/refractory multiple myeloma were randomized 1:1 to receive elotuzumab 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) in combination 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. Objective response rate was the study’s primary endpoint per response criteria established by the International Myeloma Working Group. Secondary endpoints in the trial include PFS and safety. About Elotuzumab Elotuzumab, an investigational compound in Phase 3 development, is a humanized monoclonal antibody that targets a cell-surface protein called CS1 that is highly expressed on multiple myeloma cells. Studies of elotuzumab in combination with lenalidomide and low-dose dexamethasone at a dose of 10 mg/kg are ongoing. ELOQUENT-1, a Phase 3 trial in first-line multiple myeloma trial is currently enrolling patients and a second Phase 3 trial of patients with relapsed/refractory multiple myeloma (ELOQUENT-2) is fully enrolled. Elotuzumab is also being investigated in a randomized Phase 2 study of bortezomib and dexamethasone with or without elotuzumab in relapsed or refractory multiple myeloma. About Multiple Myeloma 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 2013, it is estimated that approximately 22, 350 new cases will be diagnosed in the U.S. and that 10,710 people will die from the disease. About Bristol-Myers Squibb Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover,develop and deliver innovative medicines that help patients prevail over serious diseases. For moreinformation about Bristol-Myers Squibb, visit www.bms.com, or follow us on Twitter at http://twitter.com/bmsnews. About AbbVie AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. In 2013, AbbVie employs approximately 21,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page. Bristol-Myers Squibb Forward-Looking Statements This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee clinical trials of the compound described in this release will support a regulatory filing or that the compound will receive regulatory approval or become a commercially successful product. 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