Two major Phase III studies report oral Revlimid(R) (lenalidomide) plus dexamethasone shows increased overall survival advantage to dexamethasone plus placebo in previously treated multiple myeloma patients



    Published today in the New England Journal of Medicine

    OAKVILLE, ON, Nov. 21 /CNW/ - The New England Journal of Medicine today
published updated data from two Phase III studies that showed a combination
treatment of oral lenalidomide plus dexamethasone increased overall survival
and slowed disease progression in previously treated patients with multiple
myeloma compared to dexamethasone plus placebo. Revlimid is currently under
review by Health Canada for the treatment of multiple myeloma and MDS with
deletion 5q.
    "The experience at our centre with lenalidomide has been extremely
positive," says Dr. Christine Chen, co-author of the NEJM paper and
hematologist within the Myeloma Clinical Research Group at Princess Margaret
Hospital and the largest recruiting hospital across North America for this
trial. "The trial demonstrates that patients treated with lenalidomide and
dexamethasone respond better and for greater periods of time, experience
slower progression of disease, and survive longer than those treated with
dexamethasone plus placebo. Also, lenalidomide is an oral drug thus it allows
patients to take the medication at home and remain as independent as
possible."
    Multiple myeloma is a cancer of the blood in which malignant plasma cells
are overproduced in the bone marrow. It is the second most prevalent blood
cancer after non-Hodgkin's lymphoma and represents approximately 1% of all
cancers and 2% of all cancer deaths.(1) There are currently about 6,000
Canadians living with multiple myeloma, and approximately 1,840 people are
diagnosed with the disease every year in Canada.(2)

    New England Journal of Medicine Data

    The North American Phase III pivotal study (MM-009) evaluated
lenalidomide plus dexamethasone in 353 multiple myeloma patients. Those
included in the trial had been heavily treated prior to enrollment, many
having failed three or more rounds of therapy with other agents. The key
findings from the North American Phase III trial included:

    
    -   Median time-to-disease progression with lenalidomide plus
        dexamethasone was 11.1 months, compared with 4.7 months for
        dexamethasone plus placebo (p less than 0.0001)
    -   Median overall survival with lenalidomide plus dexamethasone was
        29.6 months, compared with 20.2 months for dexamethasone plus placebo
        (p less than 0.0001)
    -   Overall response rate with lenalidomide plus dexamethasone was 61
        percent, compared with 19.9 percent for dexamethasone plus placebo
        (p less than 0.001)
    -   Complete and near complete response rate with lenalidomide plus
        dexamethasone was 24.3 percent, compared with 1.7 percent for
        dexamethasone plus placebo (p less than 0.001)
    -   The most common side effects managed for in this trial with the
        combination of lenalidomide and dexamethasone were constipation,
        diarrhea, muscle cramps, fever, rash, fatigue and neutropenia
    

    Similar results were also shown in a separate New England Journal of
Medicine article based on data from the International Phase III study, MM-010.
    In the MM-010 trial, the median overall survival with lenalidomide plus
dexamethasone has not yet been reached. In an updated presentation at the
International Myeloma Foundation workshop in June 2007, pooled overall
survival for patients in the North American trial MM-009 and International
trial MM-010 with lenalidomide plus dexamethasone was 35 months - the longest
median survival reported in phase III trials in previously treated multiple
myeloma patients.
    "These results are welcome news for Canadians who have multiple myeloma,"
says John Lemieux, President of Myeloma Canada, the only national patient
organization uniquely devoted to the myeloma community. "Scientific research
into new treatments brings renewed hope to people living with this incurable
disease, especially patients for whom there were no other medical options. We
are hopeful that new advances for these patients, like this combination
therapy, will lead to a better quality of life and more precious days with
family and friends."

    About the North American and International Phase III SPA Trials

    Clinical data from the Phase III trials will continue to be accumulated
and updated, through patient follow-up, on an ongoing basis. These trials were
designed to investigate the effectiveness and safety of cyclic dosing of
lenalidomide at 25mg combined with high-dose dexamethasone (HDD) compared with
placebo and HDD in previously treated patients with multiple myeloma. These
trials enrolled 705 patients and are being conducted in 97 sites
internationally. Lenalidomide and HDD are given in 28-day cycles: lenalidomide
25 mg once daily on days 1-21 every 28 days, and HDD 40 mg on days 1-4, 9-12
and 17-20 every 28 days. After four cycles the HDD schedule is reduced to 40
mg on days 1-4 every 28 days. The primary endpoint of the study is time-to-
disease progression calculated as the time from randomization to the first
documentation of progressive disease based on EBMT myeloma response criteria.

    About Revlimid (lenalidomide)

    Revlimid is a medicine containing the active substance lenalidomide. It
is the first of Celgene's group of proprietary compounds of immunomodulatory
agents called IMiDs(R). 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.
    In Canada, Revlimid is only available through participation in a clinical
study.

    About Celgene

    Celgene Corporation is an integrated global biopharmaceutical company
engaged primarily in the discovery, development and commercialization of novel
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.

    
    References
    -------------------

    1. Myeloma Canada
       http://www.myelomacanada.ca/en/cause_and_incidence.asp

    2. Myeloma Canada
       http://www.myelomacanada.ca/en/introduction_to_myeloma.asp
    




For further information:

For further information: FOR MEDIA INTERVIEWS: Fiona Robinson, Celeste
Brown, Hill and Knowlton Canada, (416) 413-4737, (416) 413-4651,
fiona.robinson@hillandknowlton.ca, celeste.brown@hillandknowlton.ca

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