Celgene Corporation
Dec 13, 2011
PDF
Add to Briefcase

REVLIMID® Evaluated in Combination with Rituximab as a Potential Treatment for Patients with Treatment-Naive Chronic Lymphocytic Leukemia

Study Demonstrated Overall Response Rate of 95% for Patients under 65 Years of Age

BOUDRY, Switzerland--(BUSINESS WIRE)--Dec. 13, 2011-- Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG), announced results from an investigational study evaluating REVLIMID (lenalidomide) in combination with rituximab in patients with treatment-naive chronic lymphocytic leukemia (CLL). These data were presented at the 53rd Annual Meeting of the American Society of Hematology in San Diego, CA.

The multicenter phase II study enrolled 69 patients and evaluated the efficacy and safety of combination therapy with lenalidomide and rituximab in untreated patients with chronic lymphocytic leukemia. Forty patients less than 65 years of age were evaluated in arm A, and 29 patients 65 years of age and older were evaluated in arm B. Patients received lenalidomide at 2.5 mg per day and could escalate to 5 mg per day on day eight of cycle 1 and again on day one of cycle 3 to a maximum of 10 mg per day if tolerated. Patients received lenalidomide for 21 of 35 days for cycle 1, then for 21 days of a 28-day cycle for cycles 2-7 for a total of seven cycles. Rituximab was started at the end of cycle 1 at 50 mg/m2 on day 29, 325 mg/m2 on day 31, 375 mg/m2 on day 33 of cycle 1, and then 375 mg/m2 weekly x 4 weeks for cycle 2 and on day 1 for cycles 3-7. In addition, patients received allopurinol 300 mg daily as prophylaxis for tumor lysis syndrome and, following a protocol amendment, aspirin at 81 mg daily.

Results of the study included an overall response rate (ORR) of 95% for patients less than 65 years of age (arm A), with 20% of patients achieving a complete response (CR). For patients 65 years of age and older (arm B), the ORR was 78%, with 7% of patients achieving a CR. With a median follow-up of 18 months, patients in arm A achieved a median progression-free survival of 19 months. Patients in arm B achieved a median progression-free survival of 20 months with a median follow-up of 17 months.

The most common grade 3 or 4 non-hematological adverse events were reported for 37% of patients in arm A and 52% of patients in arm B. The most common grade 3 or 4 hematological adverse events in arm A and arm B, respectively, were neutropenia (53% vs. 62%), anemia (10% vs. 7%) and thrombocytopenia (3% vs. 3%). Infusion and tumor flare reactions were observed more frequently during cycle 1 than in subsequent cycles.

These data are from an investigational study. REVLIMID does not have marketing approval for the treatment of patients with CLL.

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.

U.S. Regulatory Information for Revlimid®

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 (lenalidomide) 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 in the United States 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, WARNINGS AND PRECAUTIONS, and ADVERSE REACTIONS.

About Chronic Lymphocytic Leukaemia

CLL is the most common type of leukaemia in adults, accounting for approximately 30-40% of all forms of leukaemia in Western countries. Overall incidence of CLL is around four per 100,000 and is 50% more common in men than in women. CLL is currently considered incurable; therefore the aim of treatment is to control the disease by managing symptoms and extending the time patients live without their disease worsening.

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

Celgene International Sàrl
Investors:
+41 32 729 8303
ir@celgene.com
or
Media:
+41 32 729 8304
media@celgene.com