Celgene Corporation
Dec 13, 2011
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Phase III Study Evaluating REVLIMID® in Patients with High-Risk Smoldering Multiple Myeloma Presented at ASH

Three Year Overall Survival from Inclusion Was 93% for Patients Treated with REVLIMID® and Dexamethasone Compared to 76% for Patients under Observation Only

BOUDRY, Switzerland--(BUSINESS WIRE)--Dec. 13, 2011-- Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG), announced that updated data evaluating continuous treatment with REVLIMID® (lenalidomide) in patients with high-risk asymptomatic smoldering multiple myeloma were presented at the 53rd Annual Meeting of the American Society of Hematology. The study demonstrated that early treatment with lenalidomide and dexamethasone followed by continuous lenalidomide delayed time to symptomatic disease and demonstrated a projected survival advantage compared with observation.

The Phase III, randomized, multicenter, open-label study evaluated whether continuous treatment with lenalidomide in high-risk asymptomatic smoldering multiple myeloma patients prolonged time to progression to symptomatic disease compared with patients who did not receive treatment and were just observed, which is the current standard of care for smoldering multiple myeloma.

Of 119 evaluable patients, 57 were treated with lenalidomide (25 mg daily on days 1-21 of a 28-day cycle) and dexamethasone (20 mg on days 1-4 and 12-15 of a 28-day cycle) for nine four-week cycles and then continued treatment with a lower dose of lenalidomide (10 mg daily on days 1-21 of a 28-day cycle) until disease progression, while there were 62 patients in the therapeutic abstention arm.

After a median follow-up of 22 months, 9 of 57 (15%) patients progressed to symptomatic disease in the treatment arm. In addition, 14 patients developed biological progression during maintenance, and dexamethasone was added according to protocol, with 10 of these patients subsequently achieving disease control. In the no treatment arm, 37 of 61 patients (59%) progressed to active MM. The median time to progression (TTP) from inclusion was 23 months for the delayed treatment arm, while the median TTP has not been reached in the treatment arm (p<0.0001) (HR 6.0; 95% CI=2.9-12.6). Of note, 20 of the 37 patients in the no-treatment arm whose disease progressed developed bone lesions as a symptom of active MM. Three-year overall survival (OS) from inclusion was 93% for the treatment arm and 76% for the no-treatment arm (p=0.04). The difference in estimated OS from diagnosis was more pronounced (HR: 5.01; 95% IC [1-22]; p=0.03).

No Grade 4 adverse events were reported. Grade 3 adverse events during induction included asthenia (7%, 4/57), diarrhea (4%, 2/57), infection (2%, 1/57), anemia (2%, 1/57) and skin rash (2%, 1/57).

Three patients in the treatment arm developed second primary malignancies (SPM). One developed polycythemia vera JAK2+ during treatment, but an analysis of a frozen DNA sample obtained at the time of screening showed that the patient was already JAK2+ at enrollment. The second two SPMs were prostate cancer in patients with previous history of prostate enlargement plus elevated prostate specific antigen (PSA).

These data are from an investigational study. REVLIMID is not approved as a treatment for high-risk smoldering multiple myeloma.

About REVLIMID®

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 United States, Canada, Switzerland, Australia, New Zealand and several Latin American countries, as well as Malaysia and Israel, 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.

Since 1998, Celgene continues to be a pioneer in creating environments in which patients can benefit from our disease-altering therapies safely. As a result, hundreds of thousands of patients worldwide have accessed the clinical benefits of our therapies through our performance-based risk management programs including, S.T.E.P.S.®, RevAssist® and RevMate®, which form the foundation of our commitment to patient safety.

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 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 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.

Forward-Looking Statements

This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," “outlook” and similar expressions. Forward-looking statements are based on management’s current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in our Annual Report on Form 10-K and our other reports filed with the Securities and Exchange Commission.

Source: Celgene International Sàrl

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