New Data Show Revlimid(R) (lenalidomide) Offers Significant Survival Gainsfor People With Life-limiting Blood Cancer

Main Category: Blood / Hematology
Article Date: 09 Apr 2008 - 9:00 PDT

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According to data presented today at the 48th Annual Scientific Meeting of the British Society for Haematology (BSH), patients taking Revlimid® (lenalidomide) plus high dose dexamethasone for treatment of multiple myeloma experience a significant survival gain. On average, patients experienced nearly three extra years of life when treated with lenalidomide plus high dose dexamethasone (4.7 life years) compared with dexamethasone alone (1.9 life-years).1

Myeloma is a type of blood cancer that develops in the bone marrow's plasma cells. There are nearly 3,800 cases of myeloma in the UK per year with more than 2,400 people dying from the disease annually. 2

"The data presented today further substantiates previous outstanding trial results," stated Dr Steve Schey, Clinical Lead for Myeloma, King's College Hospital, London and Chair of the UK Myeloma Forum. "Lenalidomide will give patients the opportunity to live with their cancer for years rather than months. It represents a major step forward towards turning myeloma into a chronic disease rather than the death sentence it has been until now."

In trials evaluating lenalidomide plus high dose dexamethasone versus dexamethasone alone, many patients receiving dexamethasone alone were switched to lenalidomide combination at disease progression given the significantly better efficacy of the lenalidomide combination. As a result, the true survival gain for the dexamethasone alone group was previously overestimated. Today's data revealed a more accurate lifetime simulated survival rate for patients taking dexamethasone alone to account for the cross over of treatment in trials, based on pooled data from the UK Medical Research Council (MRC).1

Dr Schey continued, "These projected figures give us a more realistic picture of the real benefits we can hope to see in patients with lenalidomide, versus the older standard of treatment."

Additional data also presented at the BSH demonstrated that lenalidomide is a costeffective treatment. The results show that the incremental cost-effectiveness ratio is £28,980 per quality adjusted life year (QALY) for patients taking lenalidomide when compared with the older standard treatment. This cost is lower than the threshold of £30,000 per QALY that is widely considered to be an acceptable value for an additional QALY.3

"The licensing of lenalidomide in the UK represented a major advance for patients with myeloma," stated Eric Low Chief Executive of Myeloma UK. "We are currently working with HTA authorities to ensure that patients have wider access to new treatment options such as this."

Lenalidomide is currently undergoing a review by the Scottish Medical Consortium (SMC), with a decision anticipated in May 2008.

About myeloma

Myeloma is a type of blood cancer that develops in the bone marrow's plasma cells. Since myeloma can develop wherever there are plasma cells, it can arise in several places in the body and so is often called multiple myeloma. In myeloma, too many plasma cells are made and the body is unable to make normal white blood cells, red blood cells and platelets. The lack of white and red blood cells and platelets means that people with myeloma are more prone to infections, feel tired and breathless, and prone to bleeding problems.4

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 Revlimid®

Revlimid® (lenalidomide) (which is the active substance in the treatment) is the first of the IMiDs®, to be licensed, a proprietary group of novel immunomodulatory agents developed by the biopharmaceutical company Celgene. Immunomodulatory agents enhance or suppress the immune system. It is an oral treatment, which means that patients no longer need to go to hospital for all their treatment courses.

The results of trials using Revlimid® (lenalidomide) have shown better results in patients with multiple myeloma than ever seen before.5

- In nearly two thirds (60.2%) of patients taking lenalidomide plus dexamethasone the signs and symptoms of their myeloma either disappeared or were substantially reduced compared with a quarter (24%) for those on dexamethasone plus a dummy drug called a placebo. (Dexamethasone is a corticosteroid used to treat inflammatory and autoimmune conditions as well as some cancers.)

- Overall survival was significantly improved in the lenalidomide group.

- In this same trial, the patients taking lenalidomide were free of the signs and symptoms of cancer for longer than those who had received dexamethasone and placebo, at 16.5 months.

- Patients in the trial treated with lenalidomide also experienced the longest disease-free stretch of time ever reported in clinical trials. In the trial the median time until the disease came back for the patients taking lenalidomide plus dexamethasone, was 11.3 months - more than double the time for patients taking dexamethasone and placebo, 4.7 months.

The most common side effects associated with lenalidomide are low platelets (small cell fragments in the blood essential for clotting), low white blood cells, and diarrhoea. Other reported adverse events include constipation, rash, itchiness, weakness, dizziness and fatigue. Lenalidomide has also demonstrated a risk of deep vein thrombosis in some patients with certain medical conditions. Many of these serious adverse events are consistent with the patients' disease state, age, and other health problems.5

About Celgene UK

Celgene UK is a wholly-owned subsidiary of Celgene Corporation. Celgene Corporation, with its worldwide headquarters 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.

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.

References

1. J. Ishak, et al., "Modeling overall survival in the event of patient cross-over from dexamethasome to lenalidomide in phase III multiple myeloma trials" presented at the British Society for Haematology (BSH) meeting in April 2007 in Glasgow.

2. Cancer Research UK. UK Multiple myeloma incidence statistics. Accessed February 2008.

3. B. Deniz, et al., "Economic evaluation of lenalidomide for the treatment of multiple myeloma in Scotland in patients who have received one prior therapy" presented at the British Society for Haematology (BSH) meeting in April 2007 in Glasgow.

4. Cancer Research UK. What is myeloma? accessed February 2008

5. Dimopoulos M, Spencer A, Attal M, et al. Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma. N Engl J Med 2007; 357: 2123-32

Celgene UK