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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

INDIANAPOLIS, May 19, 2011 /PRNewswire/ -- 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: 1 mg (n=3), 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 protein.  Multiple myeloma causes hypercalcemia, anemia, low platelet counts, increases the risk of infection and weakens the bones increasing the risk of fracture, pain, and disability.  Across the U.S. more than 20,000 new cases of multiple myeloma are reported each year, with approximately 10,500 deaths attributed to the disease annually.(1)

About Lilly Oncology

For more than four decades, Lilly Oncology, a division of Eli Lilly and Company, has been dedicated to delivering innovative solutions that improve the care of people living with cancer.  Because no two cancer patients are alike, Lilly Oncology is committed to developing novel treatment approaches.  To learn more about Lilly's commitment to cancer, please visit www.LillyOncology.com.  

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations.  Headquartered in Indianapolis, Ind., Lilly provides answers – through medicines and information – for some of the world's most urgent medical needs.

P-LLY

bortezomib, Velcade®, Millenium Pharmaceuticals

This press release contains forward-looking statements about the potential of LY2127399 and reflects Lilly's current beliefs. However, as with any pharmaceutical compound, there are substantial risks and uncertainties in the process of development and commercialization. There is no guarantee that this compound will be approved by the relevant regulatory authorities or prove to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's filings with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

(1)  U.S. National Library of Medicine. Multiple Myeloma. National Center for Biotechnology Information. http://www.cancer.gov/cancertopics/types/myeloma. (April 25, 2011).

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