Landmark Analysis Shows Continuous Treatment With REVLIMID(R) Plus Dexamethasone Significantly Increases Overall Survival In Multiple Myeloma Patients

Main Category: Lymphoma / Leukemia / Myeloma
Also Included In: Cancer / Oncology
Article Date: 10 Dec 2008 - 4:00 PDT

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Celgene International Sàrl (NASDAQ: CELG) announced that data from a landmark analysis of patients with relapsed/refractory multiple myeloma found that continuous treatment with REVLIMID (lenalidomide) in combination with dexamethasone after achieving best response resulted in significantly longer overall survival and increased time to disease progression compared to those who discontinued treatment after ten months or less. The results of this analysis were presented today at the 50th Annual Meeting of the American Society of Hematology (ASH).

"The findings show that, as long as patients are responsive to treatment and their side effects are manageable, they should be maintained on therapy, since continuing treatment can improve outcomes and overall survival significantly," said Jesus San Miguel, MD, Head of the Department of Hematology, University of Salamanca, and lead author on the study. "Patients and doctors should work together to manage side effects so that treatments can be continued."

Multiple myeloma is a cancer of the blood in which plasma cells, or white blood cells, are overproduced in the bone marrow. The disease accounts for one-fifth of all deaths from hematologic cancers.

This analysis of 321 patients found that, 24 months after achieving their best response, 93.8 percent of patients who continued therapy for more than 10 months were still alive, whereas only 48.4 percent of those who were treated for 10 months or less survived.

A second analysis completed as part of the same study showed that patients who discontinued therapy with REVLIMID® early due to adverse events or withdrawal of consent had significantly shorter median overall survival times (29.5 months) and times to disease progression (13.6 months) than did those who continued therapy. For those who continued therapy median overall survival and time to progression were not yet reached at time of analysis. Patients who stopped treatment due to disease progression were excluded from the study; therefore the results show that patients benefit from continuing treatment.

REVLIMID is currently approved in the European Union, the 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, Australia and Japan.

About REVLIMID

REVLIMID is an IMiDs® compound, a member of a proprietary group of novel immunomodulatory agents. REVLIMID and other IMiDs continue to be evaluated in over 100 clinical trials in a broad range of hematological and oncological conditions. The IMiDs pipeline is covered by a comprehensive intellectual property estate of issued and pending patent applications in the US, EU and other regions, 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 Sàrl

Celgene International Sàrl, located in Boudry, in the Canton of Neuchâtel, 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 http://www.celgene.com.

This release contains forward-looking statements which are subject to 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 expressed or 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 other factors described in the Company's filings with the Securities and Exchange Commission such as our 10K, 10Q and 8K reports.

Celgene International Sàrl

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