New Analysis Shows That REVLIMID® Plus Dexamethasone Yielded A Mean Survival Of 5.6 Years For Patients With Multiple Myeloma

Main Category: Lymphoma / Leukemia / Myeloma
Also Included In: Blood / Hematology;  Clinical Trials / Drug Trials
Article Date: 17 Jun 2008 - 1:00 PDT


Celgene Corporation (NASDAQ: CELG) has 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® (lenalidomide) plus dexamethasone significantly increased their survival rates.[1] 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.[1]

"This analysis shows that REVLIMID has the potential to more than double the years of survival for patients," commented Professor Gareth Morgan from the Royal 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 type of blood cancer into a chronic, manageable disease. This simulation reinforces previous study results on REVLIMID's efficacy and increased survival years."

This analysis follows on from the phase III randomized, controlled studies, MM-009 and MM-010 studies recently published in the New England Journal of Medicine.[2] 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.

Myeloma is the second most common form of bone marrow cancer[3]. There are nearly 3,800 new cases of multiple myeloma in the UK each year[4] and more than 2,400 people die from multiple myeloma in the UK each year[5].

About REVLIMID®

REVLIMID was licensed for use in the UK in June 2007 for the treatment of multiple myeloma in combination with dexamethasone in patients who have had received at least one prior treatment for their cancer.

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 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 UK

Celgene UK 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 http://www.celgene.com.

REVLIMID® is a registered trademark of Celgene Corporation.

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.

References

1 Morgan,G. Overall Survival with Dexamethasone in Phase II Multiple Myeloma Trials after Adjustment for Cross-Over to Lenalidomide. Abstract 0441. EHA 14 June 2008

2 Dimopoulos M, et al. Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma. N Engl Med; 357: 21, 22 November 2007

3 Myeloma UK. About myeloma, facts and figures. http://www.myelomaonline.org.uk/NetCommunity/Page.aspx?&pid=476&srcid=755 Accessed February 2008

4 Cancer Research UK. UK Multiple myeloma incidence statistics. http://info.cancerresearchuk.org/cancerstats/types/multiplemyeloma/incidence/ Accessed February 2008.

5 Cancer Research UK. Myeloma statistics. http://info.cancerresearchuk.org/cancerstats/types/multiplemyeloma/ Accessed February 2008.

Source:
Andrew Robertson
http://www.celgene.com

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