REVLIMID® (Lenalidomide) Plus Low-Dose Dexamethasone Achieves Unprecedented Survival Rate in ECOG Phase III Trial in Newly Diagnosed Multiple Myeloma



    Best Overall Response Achieved in Both Low-Dose and High-Dose Arms of the Study Were 71% and 82% Respectively


    CR/VGPR Rates Achieved in Both Low-Dose and High-Dose Arms of the Study Were 42% and 52% Respectively

    Median Duration of Response Not Yet Reached after 21 Months Follow-up

    Patients Who Continued on Treatment past 6 Months from Both the Low-Dose and High-Dose Arms of the Trial Achieved 99% and 97% One-Year Survival Rates Respectively

    REVLIMID Plus Low-Dose Dexamethasone Improves One-Year (96% and 88% Respectively) and Two-Year (87% and 75% Respectively) Survival Over REVLIMID Plus High-Dose Dexamethasone

    Of Patients Who Went to Stem Cell Harvest, 97% Achieved Successful Stem Cell Collection

    Favorable Safety Profile Including Very Low Incidence of Peripheral Neuropathy

    Preferred Oral Regimen Offers New Treatment Option for Patients

    Celgene International Sarl (NASDAQ: CELG) announced that updated clinical data from the Eastern Cooperative Oncology Group´s (ECOG) large, randomized Phase III trial evaluating oral REVLIMID
    (lenalidomide) with low-dose dexamethasone continued to demonstrate superior overall survival rates for newly diagnosed multiple myeloma patients compared to REVLIMID with the standard high-dose
    dexamethasone. Overall survival, the most important outcome for patients and physicians, is 96% at one year and 87% at two years. The efficacy data (Abstract #74), presented today at the 49th annual
    meeting of the American Society of Hematology (ASH), for the first time expand on initial safety analysis presented in June.

    "This is a landmark trial that supports the continuing paradigm
    shift in the treatment of myeloma and other blood cancers," said
    Jean-Luc Harousseau, M.D., founding member of the Intergroupe
    Francophone du Myelome. "We are seeing long-term results with fewer
    side effects in patients of all ages. These are the best survival data
    we have seen in newly diagnosed multiple myeloma."

    REVLIMID(R) was active with both dose levels of dexamethasone. The
    best overall response for high-dose dexamethasone (CR/VGPR/PR) was 82%
    compared to 71% in the low-dose dexamethasone arm, including 52% and
    42% CR/VGPR. After a median 21 months follow-up, the median duration
    of response has not been met in either arm. While the low dose arm had
    lower response rates, it was associated with superior overall
    survival. Additionally, time to disease progression and
    progression-free survival were similar in both arms of the study.

    The 87% survival rate in the arm with REVLIMID and low-dose
    dexametheason at two years showed an advantage compared to the two
    year survival rate of 75% for patients who received REVLIMID and
    high-dose dexamethasone. Increased overall survival was seen in
    patients receiving REVLIMID and low-dose dexamethasone regardless of
    age, however patients under the age of 65 showed a two year survival
    probability of 91% compared to 85% using high-dose dexamethasone at
    two years. In patients who continued on treatment past 6 months, the
    99% survival rate showed an advantage compared to a survival rate of
    97% for patients who received REVLIMID and high-dose dexamethasone at
    one year.

    97% of patients in both arms of the study who decided to undergo
    stem cell harvest were successfully harvested.

    Lowering the dose of dexamethasone in combination with REVLIMID
    reduced major grade 3 or higher non-hematologic toxicities, including
    deep vein thrombosis (DVT)/pulmonary embolism (PE) (9% vs. 25%).
    Neutropenia in the REVLIMID/low-dose dexamethasone arm (19%) was
    slightly increased compared to REVLIMID/high-dose dexamethasone,
    although infections were lower in the low-dose dexamethasone arm (7%
    vs. 14%). Grade 4 toxicities were also significantly lower in the
    low-dose arm (8%), compared to 19% in the high-dose arm.

    "The lower survival rates with the high dose dexamethasone can be
    attributed to disease progression as well as treatment-related
    toxicities," said S. Vincent Rajkumar, M.D., Mayo Clinic Cancer Center
    hematologist and lead investigator of the study. "This is a major
    advance in the treatment of this cancer, and also gives researchers a
    new direction to explore -- that more is not necessarily better."

    Last April, the ECOG Data Monitoring Committee reviewed the
    preliminary results from the trial and recommended that the survival
    results be made public because of the early differences seen in the
    overall survival rates. All patients in the high-dose dexamethasone
    arm of the clinical trial were moved to the lose-dose arm based upon
    these interim findings at that time as well. As a result of these
    findings, REVLIMID is the foundation for several upcoming newly
    diagnosed multiple myeloma trials: ECOG E4A03, SWOG S0232, INTERGROUP,
    S0777, IFM 07-01, ECOG E1A06, and Celgene-sponsored trial MM-020.

    About REVLIMID(R)

    REVLIMID is currently approved in the United States, the EU, and
    Switzerland for treatment of patients with multiple myeloma in
    combination with dexamethasone who have received at least one prior
    therapy. REVLIMID is also approved in the United States for
    transfusion-dependent anemia due to low- or intermediate-1-risk MDS
    associated with a deletion 5q cytogenetic abnormality with or without
    additional cytogenetic abnormalities. REVLIMID has obtained Orphan
    Drug designation in the EU, U.S., Switzerland and Australia.

    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 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.