Celgene International Sarl (Nasdaq:CELG) announced that data presented today at the 13th Congress of the European Hematology Association (EHA) in Copenhagen, Denmark found that patients previously treated for multiple myeloma receiving REVLIMID (lenalidomide) in combination with dexamethasone experienced a significant survival gain regardless of the number of prior therapies they had received.
The results showed that not only was the use of REVLIMID and dexamethasone associated with a substantial improvement in survival, but also was cost-effective with the incremental cost-effectiveness threshold range from GBP 20,000 to GBP 30,000 per quality adjusted life year (QALY). This is widely considered to be an acceptable value for an additional QALY, compared to patients receiving dexamethasone alone.
The results from the analysis presented at EHA were obtained from the assessment of pooled data from several clinical trials, including two large, multi-center, international phase III randomized clinical trials (MM-009/010) evaluating REVLIMID in patients who had previously been treated for multiple myeloma and were applied to the management costs reflective of NHS Wales.
Patients treated with REVLIMID and dexamethasone had an increase in side effects as compared to patients treated with dexamethasone plus placebo. Grade 3/4 toxicities included neutropenia, thrombocytopenia and anemia. Deep vein thrombosis and pulmonary embolism occurred in 9.0 percent of patients treated with lenalidomide plus dexamethasone, compared to 6.0 percent of patients treated with dexamethasone plus placebo in MM-010, and deep vein thrombosis and pulmonary embolism occurred in 14.1 percent of patients treated with lenalidomide plus dexamethasone, compared to 3.4 percent of patients treated with dexamethasone plus placebo in MM-009.
Multiple myeloma is the second most commonly diagnosed blood cancer. There are approximately 80,000 people with the disease in Europe at any given time and according to the International Myeloma Foundation, there are an estimated 750,000 people with multiple myeloma worldwide.
About REVLIMID(R)
REVLIMID is an IMiDs(R) 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, Switzerland, is a wholly owned subsidiary and international headquarters of Celgene Corporation. Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical 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.
Abstract # 0804
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