Celgene Corporation
Dec 4, 2010
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Phase III Study Evaluating REVLIMID® in Patients with High-Risk Smoldering Multiple Myeloma Reported Statistically Significant Reduction in Risk of Disease Progression

Study Showed Overall Response Rate of 91% for Patients Who Completed Initial 9 Treatment Cycles

Phase III Study Evaluating REVLIMID(R) in Patients with High-Risk Smoldering Multiple Myeloma Reported Statistically Significant Reduction in Risk of Disease Progression

BOUDRY, Switzerland, Dec 04, 2010 (BUSINESS WIRE) --

Celgene International Sàrl (NASDAQ: CELG) announced that data evaluating combination therapy REVLIMID® (lenalidomide) and dexamethasone in patients with high-risk asymptomatic smoldering multiple myeloma were presented during the American Society of Hematology's annual meeting. The study reported REVLIMID and dexamethasone prolonged time to progression.

The Phase III, randomised, multicenter, open-label study evaluated whether early treatment with REVLIMID and dexamethasone in high-risk asymptomatic smoldering multiple myeloma patients prolonged time to progression to symptomatic disease compared to patients that did not receive treatment and were just observed.

Patients were treated with REVLIMID (25mg daily on days 1-21 of 28-day cycle) and dexamethasone (20mg on days 1-4, 12-15 of 28-day cycle) for nine four-week cycles and then continued treatment with a lower dose of REVLIMID (10mg daily on days 1-21 of 28-day cycle) until progression. The results showed an overall response rate of 75% (43/57), including 51% (29/57) PR, 12% (7/57) VGPR, 5% (3/57) CR and 7% (4/57) stringent CR (sCR). For the patients who completed the initial nine treatment cycles, the overall response rate was 91% (30/33), including 15% (5/33) VGPR, 9% (3/33) CR and 9% (3/33) sCR. For patients who then went on to receive continuous lenalidomide treatment, the sCR rate increased to 16% (5/32).

After a median follow-up of 16 months, disease progression was observed in 3% (4/118) of patients treated with REVLIMID and dexamethasone, while 18% (21/118) of patients progressed to active myeloma in the observation arm. Eleven out of these 21 patients also developed bone lesions due to active myeloma.

The median time to symptomatic myeloma was 25 months in patients in the observation arm and has not yet been reached for patients who received REVLIMID and dexamethasone (P<0.0001).

No Grade 4 adverse events were reported. Grade 3 adverse events included asthenia (7% 4/57), diarrhea (4% 2/57), infection (4% 2/57), anaemia (2% 1/57) and skin rash (2% 1/57). One patient discontinued treatment because of adverse events. Dose adjustments were made as necessary to manage toxicity.

REVLIMID is not approved as a treatment for high-risk smoldering multiple myeloma.

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 tumours. The cause of the disease remains unknown. Smoldering myeloma patients have elevated levels of malignant plasma cells in the bone marrow that produce M protein, however they do not have the clinical manifestations or symptoms of multiple myeloma.

About REVLIMID®

REVLIMID is an IMiDs® compound. REVLIMID and other IMiDs continue to be evaluated in over 100 clinical trials. The IMiDs pipeline is covered by a comprehensive intellectual property estate of issued and pending patent applications in the US, EU and other regions, including composition-of- matter and use patents.

REVLIMID is approved in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy in nearly 70 countries, encompassing Europe, the Americas, the Middle-East and Asia, and in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy in Australia and New Zealand.

REVLIMID is also approved in the Americas, the Middle-East and Asia for transfusion-dependent anaemia due to low- or intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Marketing Authorization Applications are currently being evaluated in a number of other countries.

REVLIMID® (lenalidomide) in combination with dexamethasone is indicated for the treatment of multiple myeloma (MM) patients who have received at least one prior therapy.

REVLIMID is indicated for patients with transfusion-dependent anaemia due to Low- or Intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

Important Safety Information

WARNING: FETAL RISK, HEMATOLOGIC TOXICITY, and DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM

Do not use REVLIMID during pregnancy. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study. Thalidomide is a known human teratogen that causes severe life-threatening human birth defects. If lenalidomide is used during pregnancy, it may cause birth defects or death to a developing baby. In women of childbearing potential, obtain 2 negative pregnancy tests before starting REVLIMID treatment. Women of childbearing potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after REVLIMID treatment. To avoid fetal exposure to lenalidomide, REVLIMID is only available under a restricted distribution program called "RevAssist®."

Information about the RevAssist program is available at www.REVLIMID.com or by calling the manufacturer's toll-free number 1-888-423-5436.

HEMATOLOGIC TOXICITY (NEUTROPENIA AND THROMBOCYTOPENIA)

REVLIMID can cause significant neutropenia and thrombocytopenia. Eighty percent of patients with del 5q MDS had to have a dose delay/reduction during the major study. Thirty-four percent of patients had to have a second dose delay/reduction. Grade 3 or 4 hematologic toxicity was seen in 80% of patients enrolled in the study. Patients on therapy for del 5q MDS should have their complete blood counts monitored weekly for the first 8 weeks of therapy and at least monthly thereafter. Patients may require dose interruption and/or reduction. Patients may require use of blood product support and/or growth factors. (see DOSAGE and ADMINISTRATION)

DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM

REVLIMID has demonstrated a significantly increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients with MM who were treated with REVLIMID and dexamethasone therapy. Patients and physicians are advised to be observant for the signs and symptoms of thromboembolism. Patients should be instructed to seek medical care if they develop symptoms such as shortness of breath, chest pain, or arm or leg swelling. It is not known whether prophylactic anticoagulation or antiplatelet therapy prescribed in conjunction with REVLIMID may lessen the potential for venous thromboembolic events. The decision to take prophylactic measures should be done carefully after an assessment of an individual patient's underlying risk factors.

CONTRAINDICATIONS:

Pregnancy Category X:

Allergic Reactions:

WARNINGS AND PRECAUTIONS:

Fetal Risk:

Reproductive Risk and Special Prescribing Requirements (RevAssist Program):

Hematologic Toxicity--Multiple Myeloma:

Deep Vein Thrombosis:

Allergic Reactions:

Tumour Lysis Syndrome:

Tumour Flare Reaction:

DRUG INTERACTIONS:

USE IN SPECIAL POPULATIONS:

Nursing Mothers:

Geriatric Use:

Renal Impairment:

ADVERSE REACTIONS:

Multiple Myeloma

Myelodysplastic Syndromes

DOSAGE AND ADMINISTRATION:

Please see full Prescribing Information, including Boxed WARNINGS, CONTRAINDICATIONS, PRECAUTIONS, and ADVERSE REACTIONS.

About Celgene International Sàrl

Celgene International Sàrl, located in Boudry, in the Canton of Neuchâtel, 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. The company's actual results, performance, or achievements could be materially different from those projected by these forward-looking statements. The factors that could cause actual results, performance, or achievements to differ from the forward-looking statements are discussed in the company's filings with the Securities and Exchange Commission, such as the company's Form 10-K, 10-Q and 8-K reports. Given these risks and uncertainties, you are cautioned not to place undue reliance on the forward-looking statements.

SOURCE: Celgene International Sàrl

Celgene International Sàrl
Kevin Loth, +41 32 729 86 21
Director of External Relations