June 14, 2008
New Analysis of Phase III Studies Shows That REVLIMID(R) Plus Dexamethasone Yielded an Estimated Mean Survival of 5.6 Life Years for Patients With Multiple Myeloma
Celgene International Sarl (Nasdaq:CELG) today announced that according to data from a pooled study presented at the 13th European Hematology Association (EHA) congress in Copenhagen, Denmark, multiple myeloma patients taking REVLIMID(R) (lenalidomide) plus dexamethasone significantly increased their survival rates. A lifetime simulation yielded an estimated mean survival of 5.6 life-years with REVLIMID in combination with dexamethasone (2.2 life-years with dexamethasone alone) for patients with one prior therapy, and 4.2 life-years (1.5 life-years for dexamethasone alone) for patients with multiple prior therapies.
"This analysis shows that REVLIMID has the potential to more than double the years of survival for patients," commented Professor, MD Gareth Morgan from the Royals Marsden Hospital and the Institute for Cancer Research (UK), and lead author of the trial. "REVLIMID can give patients the opportunity to live longer and have a better quality of life. This is a milestone in the treatment of multiple myeloma and is helping to turn this critical blood cancer into a chronic, manageable disease. This simulation reinforces previous study results on REVLIMID's efficacy and increased survival years."
This analysis stemmed from the phase III randomized, controlled studies, MM-009 and MM-010 studies, recently published in the New England Journal of Medicine that demonstrated high response rates and durable remissions resulting in the longest median survival in a phase III trial ever seen in relapsed/refractory multiple myeloma patients. The analysis demonstrated that patients in the two phase III trials showed the greatest improvement to date in TTP and deepest and greatest duration response rates if used earlier on in the treatment. This study was re-analyzed to validate the long-term survival benefit to patients when appropriate adjustments are made to account for patient's crossing over to the REVLIMID treatment arm of the trial.
Patients treated with lenalidomide 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 (DVT) and pulmonary embolism (PE) 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, and DVTs and PEs 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.
Additional Data Supports REVLIMID's Survival Advantage and Quality Of Life Benefits
Another trial presented at the British Society for Haematology (BSH) Annual Meeting (April 2008) also showed that multiple myeloma patients taking REVLIMID plus dexamethasone experienced a survival gain. On average, patients experienced nearly three extra years of life (4.7 life years) when treated with REVLIMID plus high-dose dexamethasone (1.9 life-years with dexamethasone alone).
Additional data from Scotland also presented at the BSH Annual Meeting demonstrated that REVLIMID is a cost-effective treatment. This cost is lower than the threshold of GBP 30,000 per QALY that is widely considered to be an acceptable value for an additional QALY.
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 quality-adjusted life years (QALYs)
Quality-adjusted life years, or QALYs, is a way of measuring disease burden, including both the quality and the quantity of life lived, as a means of quantifying in benefit of a medical intervention.
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.