BOUDRY, Switzerland--(December 10, 2008)--Celgene International Sarl (Nasdaq:CELG) today announced more mature data from clinical studies of REVLIMID (lenalidomide) in newly-diagnosed multiple myeloma were presented at a joint symposium of the American Society of Clinical Oncology (ASCO) and the American Society of Hematology (ASH) on Sunday, Dec. 7. The results from the ECOG E4A03 study of REVLIMID plus low-dose dexamethasone (Rd) versus REVLIMID plus a standard dose of dexamethasone (RD) in newly diagnosed multiple myeloma patients detailed some of the highest three-year overall survival rates ever reported in the intent to treat population. These results showed a three-year survival rate of 75 percent in the RD arm of the study and 74 percent in the Rd arm.
Additionally, in a Landmark Analysis where patients were treated continuously with Rd therapy as opposed to stem cell transplant, patients achieved an overall response rate of 91 percent with a 57 percent complete response plus very good partial response rate (CR + VGPR).
Grade 3 or higher non-hematologic toxicities in the RD vs. Rd arms of the study included deep vein thrombosis (DVT)/pulmonary embolism (PE) (26% vs. 12%) infection/pneumonia (16% vs. 9%) cardiac ischemia (3% vs. 0.5%) and neuropathy (2% in both arms).
"These further data from the E4A03 study reinforce our view that REVLIMID plus low-dose dexamethasone has high activity and is well-tolerated long-term therapy in newly diagnosed multiple myeloma," said Mohamad Hussein, M.D., Vice President, Medical Affairs, Hematology for Celgene. "Additionally, the impressive data from the Landmark Analysis underscores the need to treat continually to control residual disease and improve outcomes."
REVLIMID is currently approved in the European Union, United States, Canada, Argentina and Switzerland in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy and in Australia in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy. REVLIMID is also approved in Canada, the United States and Argentina for transfusion-dependent anemia due to low- or intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. REVLIMID has obtained Orphan Drug designation in the EU, U.S., Switzerland and Australia and Japan.
About REVLIMID®
REVLIMID is an IMiDs® compound, a member of a proprietary group of novel immunomodulatory agents. REVLIMID and other IMiDs compounds continue to be evaluated in over 100 clinical trials in a broad range of oncological conditions, both in blood cancers and solid tumors. The IMiDs pipeline is covered by a comprehensive intellectual property estate of U.S. and foreign issued and pending patent applications including composition-of- matter and use patents.
About Multiple Myeloma
Multiple myeloma (also known as myeloma or plasma cell myeloma) is a cancer of the blood in which malignant plasma cells are overproduced in the bone marrow. Plasma cells are white blood cells that help produce antibodies called immunoglobulins that fight infection and disease. However, most patients with multiple myeloma have cells that produce a form of immunoglobulin called paraprotein (or M protein) that does not benefit the body. In addition, the malignant plasma cells replace normal plasma cells and other white blood cells important to the immune system. Multiple myeloma cells can also attach to other tissues of the body, such as bone, and produce tumors. The cause of the disease remains unknown.
About Celgene International Sarl
Celgene International Sarl, located in Boudry, in the Canton of Neuchatel, Switzerland, is a wholly owned subsidiary and international headquarters of Celgene Corporation. Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company's website at www.celgene.com.
This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company's control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company's filings with the Securities and Exchange Commission such as Form 10-K, 10-Q and 8-K reports.