Trials For Oral Therapy Revlimid (Lenalidomide) Show Unprecedented Overall Survival And Response Rates In Blood Cancer, Multiple Myeloma

Main Category: Lymphoma / Leukemia / Myeloma
Also Included In: Clinical Trials / Drug Trials
Article Date: 23 Nov 2007 - 2:00 PDT

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The results of two pivotal Phase III trials, published in this week's prestigious New England Journal of Medicine, showed that patients with the blood cancer multiple myeloma who were treated with REVLIMID® (lenalidomide) had among the longest median survival rates, the longest time until the disease progressed and the highest response (remission) rate ever reported in a Phase III trial in previously treated multiple myeloma patients.

The international and the US multi-centred, randomized, double-blind, placebo-controlled Phase III studies evaluated REVLIMID® plus dexamethasone and found that:

The median time until the disease progressed for the patients taking REVLIMID® plus dexamethasone was 11.3 months - more than double the time for patients taking dexamethasone plus placebo (4.7 months).

60.2% of the patients taking REVLIMID® plus dexamethasone had a complete or partial response (when signs and symptoms of the cancer disappear) compared with 24% for those on dexamethasone plus placebo NOTEREF Ref182994164 h * MERGEFORMAT 1. The REVLIMID® patients also had a longer lasting response at 16.5 months NOTEREF Ref182994164 h * MERGEFORMAT 1. There was an increase in overall survival rates. The data from the US study showed that patients taking REVLIMID® plus dexamethasone had an estimated median overall survival of 29.6 months versus 20.5 months in the dexamethasone/placebo arm. The median duration of overall survival in lenalidomide plus dexamethasone patients in the international trial has yet to be reached

Multiple myeloma is the second most commonly diagnosed blood cancer. According to the International Myeloma Foundation, there are an estimated 750,000 people with multiple myeloma worldwide. There are approximately 4,000 new cases annually in the UK, which represents about one percent of all newly diagnosed cancers NOTEREF Ref182994573 h * MERGEFORMAT 3 and at any one time there will be just fewer than 8,000 patients with the condition.

Multiple myeloma causes approximately 2,500 deaths each year in the UK NOTEREF Ref182994627 h * MERGEFORMAT 5 accounting for 1 in 70 deaths from cancer in the UK and Ireland. Mortality is high with 45% of patients dying in the first year and 80% within 5 years.

REVLIMID® is the first breakthrough oral cancer therapy for multiple myeloma patients in more than forty years and has been licensed for use in the UK since June 2007.

"The international study evaluating lenalidomide plus dexamethasone demonstrates the effectiveness of this treatment for patients with relapsed or refractory myeloma. Patients who received this treatment had higher response rates, longer remission periods and increased survival, compared with patients who received the control medication, dexamethasone and placebo," said Dr Kwee Yong, from University College London, one of the UK's leading multiple myeloma specialist and an investigator on the International Study.

"The data from the two published clinical trials show that REVLIMID® represents a major step forward in helping myeloma become a disease that some people can live with rather than die from. As with so many new cancer therapies, financial restrictions may deprive many patients the benefits offered by this new treatment," commented Eric Low, Chief Executive of Myeloma UK. "In fact a number of cases have already been brought to our attention by concerned patients. We will do everything we can to help these patients receive the treatments they need."

"Myeloma is a nasty disease and these impressive clinical data clearly show oral REVLIMID® is a breakthrough therapy offering multiple myeloma patients, who have failed previous therapy, renewed optimism. We will partner with the NHS to demonstrate the value of REVLIMID® to the healthcare system to ensure it is available for patients who need it," said David Allmond, General Manager of Celgene UK/Ireland.

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 which 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. The cause of the disease remains unknown and its treatment remains a true unmet medical need.

About REVLIMID®

REVLIMID® (lenalidomide) is a member of a proprietary group of novel immunomodulatory agents known as IMiDs®. In addition to multiple myeloma, REVLIMID® continues to be evaluated in a range of oncological conditions, both in blood cancers and solid tumours. Within the EU, Switzerland, Iceland and Norway,

REVLIMID® has been granted full marketing authorization by the European Commission for use in combination with dexamethasone as a treatment for patients with multiple myeloma who have received at least one prior therapy.

The U.S. Food and Drug Administration (FDA) granted approval of REVLIMID® in combination with dexamethasone as a treatment for patients with multiple myeloma, who have received at least one prior therapy.

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.

References:

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

- Weber D. et al. Lenalidomide plus dexamethasone for relapsed multiple myeloma in North America. N Engl J Med; 357: 21, 22 November 2007

- International Myeloma Foundation. http://www.Myeloma.org.uk org (accessed November 2007)

- Eric Low. Your essential Guide. http://www.Myeloma.org.uk September 2006

- Globocan 2002. International agency for research on cancer. WWW-dep.iarc.fr. Accessed on June 2007

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