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Study Determined Best Dose and Showed 55 Percent Response Rate With Lilly Anti-BAFF Monoclonal Antibody in Previously-Treated Multiple Myeloma Patients
Date:5/19/2011

10 mg (n=4), 30 mg (n=5), 100 mg (n=3) and 300 mg (n=5), in combination with bortezomib at 1.3 mg/m2.  Bortezomib was administered intravenously on days one, four, eight and 11 in a 21-day treatment cycle while LY2127399 was administered intravenously on day one in cycles one through three and on day one of every other cycle thereafter.  The median number of prior therapies for the group was three, with 65 percent of the patients having previously received bortezomib and 80 percent received either thalidomide or lenalidomide.  

LY2127399 is also in Phase III evaluation as a potential treatment for rheumatoid arthritis and systemic lupus erythematosus.

"While this molecule began its developmental journey outside of oncology, researchers recognized its potential for multiple myeloma," said Richard Gaynor, M.D., vice president of product development and medical affairs at Lilly Oncology.  "It is this kind of bench-to-bedside research that enabled us to get one step closer to providing medicines to patients in need."

Patients enrolled in the trial had relapsed or refractory multiple myeloma and had been previously treated with at least one prior regimen.  No dose-limiting toxicities were observed on the trial.  Grade 3/4 adverse events observed during the study included thrombocytopenia (n=4), neutropenia (n=3), anemia (n=1), diarrhea (n=2), neuropathy (n=2), hypercalcemia (n=1), mucositis (n=1), gastrointestinal hemorrhage (n=1), renal failure (n=1), sepsis (n=1) and pain (n=1).  Two patients discontinued the study due to neuropathy and one discontinued because of thrombocytopenia.  One patient discontinued due to progressive disease at cycle five and died three months later.

About Multiple Myeloma

Multiple myeloma is a cancer of plasma cells, a type of white blood cell that creates antibodies.  Multiple myeloma causes excess production of an abnormal antibody known as a monoclonal
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SOURCE Eli Lilly and Company
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