Lilly Phase I multiple myeloma study affirms potential of LY2127399-bortezomib combination

Eli Lilly and Company (NYSE: LLY) announced Phase I data on LY2127399, a human monoclonal antibody that neutralizes B-cell activating factor (BAFF), for use in combination with bortezomib in patients with previously-treated multiple myeloma.  Results from the Phase I study will be presented on Sunday, June 5 at 11:30 a.m. CDT during the Lymphoma and Plasma Cell Disorders Oral Abstract Session (Abstract #8012) at the 47th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Ill.  

BAFF is a soluble protein found on the surface of immune cells. In some cases, BAFF levels are increased in the serum of patients with multiple myeloma.  Researchers believe that BAFF stimulates myeloma cells to grow and resist the effects of chemotherapy.

Twenty patients were enrolled in the first-stage of the trial in order to determine the primary endpoint -- the dose of LY2127399 that can be safely used in combination with bortezomib, an approved therapy for patients with previously-treated multiple myeloma.  The analysis suggested doses of at least 100 mg of LY2127399 would be most appropriate for further study.  Researchers also assessed response rate, a secondary endpoint in this trial, and found that 11 of 20 patients achieved a partial response or better.

"This study identified the appropriate dose range and affirmed the potential of this anti-BAFF monoclonal antibody in combination with bortezomib," said Noopur Raje, M.D., the study's principal investigator and director of the Multiple Myeloma Program at the Massachusetts General Hospital and an associate professor at Harvard Medical School.  "These findings are the first step for a potential new treatment in fighting multiple myeloma."  

Patients were evaluated at five different dose levels of LY2127399.

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.