Navigation Links
Study Determined Best Dose and Showed 55 Percent Response Rate With Lilly Anti-BAFF Monoclonal Antibody in Previously-Treated Multiple Myeloma Patients

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  

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.


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. (April 25, 2011).


SOURCE Eli Lilly and Company
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Nexavar in Combination with Chemotherapy Improves Progression-Free Survival in Patients with Advanced Breast Cancer in Phase 2 Study
2. New Study Finds That 10% of Cancer Patients Abandoned Oral Anti-Cancer Drugs
3. Study Shows Improved Patient Management and Outcome Using Abbotts Sensitive Troponin Assay
4. Positive Results from Long-Term Phase 3 Study of Avanafil Featured at American Urological Association Annual Meeting
5. Food Allergies Common among Children and Linked to Environmental Allergies and Asthma Later in Life, Suggests Largest-Ever National Allergy Study
6. Exploratory Efficacy Analysis Conducted for Long-Term Extension Study in Patients With Prostate Cancer Treated With FIRMAGON® or Crossed Over to FIRMAGON From Leuprolide
7. Caldolor® Clinical Study in Hospitalized Burn Patients Published in Journal of Burn Care & Research
8. Initiation of Antiretroviral Treatment Protects Uninfected Sexual Partners from HIV Infection (HPTN Study 052)
9. CrystalGenomics Completes Phase I MAD Study of its Novel Antibiotic Candidate CG400549, and Prepares for Phase II Clinical Study
10. Kaiser Permanente Study Challenges Concerns on Effectiveness of Administering Pneumococcal & Shingles Vaccines Together
11. Star Scientific Files First Quarter Report, Updates Details of Flint Study Using RCP-006
Post Your Comments:
(Date:12/1/2015)... , Dec. 1, 2015 ... today announced that its Chief Executive Officer, ... the Oppenheimer Annual Healthcare Conference in New ... in the conference through a webcast on ... , --> ...
(Date:12/1/2015)... India and PITTSBURGH , ... today announced that it expects to be the first ... markets funded by international donors, TLE400 (Tenofovir Disoproxyl Fumarate ... mg) for $99 per patient, per year. Mylan partnered ... TLE400. The significantly reduced price could generate savings of ...
(Date:12/1/2015)... Breg, Inc ., a premier provider ... it has been awarded three contracts by Novation, a ... will have access to improved pricing for Breg,s portfolio ... goods dedicated to advancing orthopedic care.  ... population, rising prevalence of chronic conditions and the health ...
Breaking Medicine Technology:
(Date:12/1/2015)... York, NY (PRWEB) , ... December 01, 2015 ... ... epidemic in the 1980s we have seen vast improvements in scientific research and ... made significant strides, providing increased hope and relief to those affected by HIV/AIDS. ...
(Date:12/1/2015)... ... December 01, 2015 , ... The workstation boundaries for imaging ... Information Systems launches MED-TAB™ -- the world’s first portable DICOM-calibrated medical image display, ... to December 4, 2015. , MED-TAB is expected to change teleradiology because ...
(Date:12/1/2015)... ... December 01, 2015 , ... For many X-rays taken at ... accurate interpretation by the radiologist. The marking utensils are so small, however, they ... found a way to alleviate this problem. , He developed the patent-pending MARK ...
(Date:12/1/2015)... , ... December 01, 2015 , ... ... of Excellence (BHCOE) today announced that the organization has awarded Education and Developmental ... with a Distinguished Award. The award celebrates exceptional special needs providers that excel ...
(Date:12/1/2015)... ... 2015 , ... Lutronic, a leading innovator of aesthetic and medical laser and ... for sale in the United States. Clarity is a Superior Dual Wavelength Platform ... into a single platform that is easy to own and operate. , For ...
Breaking Medicine News(10 mins):