REVLIMID(R) (Lenalidomide) in Combination with Rituximab Demonstrates 70% Overall Response Rate in Hard to Treat Relapsed/Refractory Mantle Cell Lymphoma



    Celgene International Sarl (NASDAQ: CELG) reported that
    researchers from the M.D. Anderson Cancer Center in Houston, TX,
    presented early evidence of efficacy from a Phase I/II study
    evaluating lenalidomide with rituximab for the treatment of
    relapsed/refractory mantle cell lymphoma (MCL). The study indicated
    that 70% of patients achieved responses with 30% of patients achieving
    complete responses when given the combination therapy. The data were
    presented at the 49th annual American Society of Hematology (ASH)
    Meeting and the combination therapy is further being evaluated by the
    center as part of the ongoing Phase II trial.

    Study investigators believe that lenalidomide may target the
    microenviroment of the MCL cells and enhance the antibody dependent
    cell-mediated cytoxicity (ADCC) activity of rituximab. Therefore,
    patients in whom rituximab had previously stopped working were able to
    achieve responses on the combination therapy. Revlimid´s impact on
    ADCC is a newly described mechanism of action growing out of these
    studies.

    The data presented showed that seven out of ten patients achieved
    responses including three complete remissions (30%), four partial
    remissions (40%), one patient with stable disease, and two patients
    with progressive disease. The most common Grade 3/4 adverse events
    observed were neutropenia, febrile neutropenia, thrombocytopenia and
    myalgia.

    "With rituximab cancer patients can develop resistance over time.
    Revlimid may enhance the activity against the cancer cells to restore
    rituximab´s efficacy," said Dr. Wang, M.D. Anderson Cancer Center.
    "These promising efficacy and tolerability results warrant additional
    studies to further evaluate the benefits."

    18 patients were involved in the trial, all of whom had previously
    been treated with rituximab, and were given lenalidomide daily for the
    first 21 days of a 28 day cycle and rituximab (375 mg/m2) by IV
    infusion weekly for four weeks only during the first cycle with the
    first dose on Day 1 in Cycle 1. A standard dose escalation was used to
    determine that the maximum tolerated dose (MTD) of lenalidomide was 20
    mg.

    Mantle cell lymphoma (MCL) is a subtype of non-Hodgkin´s lymphoma
    (NHL). There are approximately 59,000 new cases of NHL diagnosed each
    year in the U.S. with MCL cases accounting for approximately 6% of
    these diagnoses. MCL is most frequently found in older adults and the
    average age of diagnosis is the mid-60s.

    About REVLIMID(R)

    REVLIMID has obtained Orphan Drug designation in the EU, U.S., and
    Australia. REVLIMID is approved for use as an oral treatment in
    multiple myeloma in combination with dexamethasone by the European
    Medicines Agency (EMEA). REVLIMID is currently approved in the US by
    the U.S. Food and Drug Administration (FDA) for multiple myeloma in
    combination with dexamethasone for patients who have received at least
    one prior therapy. REVLIMID is also approved for treatment of patients
    with transfusion-dependent anemia due to low- or intermediate-1-risk
    myelodysplastic syndromes (MDS) associated with a deletion 5q
    cytogenetic abnormality with or without additional cytogenetic
    abnormalities by the FDA.

    About Mantle Cell Lymphoma

    Mantle cell lymphoma (MCL) is one of several subtypes of
    non-Hodgkin´s lymphoma (NHL) and results from a malignant
    transformation of a B lymphocyte in the outer edge of the lymph node
    follicles called the mantle zone. The transformed lymphocytes, or
    lymphoma cells, grow in an uncontrolled way causing tumors to form in
    the lymph nodes leading them to enlarge and the cells can also spread
    to other tissues such as the marrow, liver and gastrointestinal tract.
    MCL is distinguished from other subtypes of B-cell lymphoma by the
    overexpression of cyclin D1, a protein that stimulates cell growth,
    which in approximately 85% of cases is caused by a genetic change
    involving chromosomes 11 and 14 and may be a result of constant
    mutations occurring in many cells, possibly independent of the effects
    of an outside, environmental factor.

    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.