Results from a Randomized Study of REVLIMID® (Lenalidomide) and Rituximab (R2) in Patients with Recurrent Follicular Lymphoma Presented at ASCO
Previously-treated lymphoma patients receiving R2 regimen demonstrated 73% objective response rate
Combination therapy resulted in a median event-free survival of 2 years with a median follow-up of 1.7 years
Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG), today announced results from a randomized study comparing REVLIMID® (lenalidomide) plus rituximab to lenalidomide monotherapy in previously treated patients with recurrent follicular lymphoma. These data were presented at the 48th American Society of Clinical Oncology Annual Meeting in Chicago, Ill.
Follicular lymphoma is the most common indolent non-Hodgkin’s lymphoma and the second most common form of non-Hodgkin’s lymphomas.
In the study, patients received either single-agent lenalidomide (15 mg in cycle 1 and 20 mg in cycles 2-12 administered on days 1-21 of each 28-day cycle) (n=45) or lenalidomide (15 mg in cycle 1 and 20 mg in cycles 2-12 administered on days 1-21 of each 28-day cycle) plus rituximab (375 mg/m2 weekly for four weeks in cycle 1) (n=44). A third arm consisting of rituximab as a single-agent was discontinued from the study as a result of low patient accrual.
Of the 89 evaluable patients, the objective response rates were 73% for patients receiving combination therapy, with 36% achieving a complete response, compared to 51% for patients receiving the lenalidomide monotherapy, with 13% achieving a complete response. With a median follow-up of 1.7 years (range 0.1 – 4.1 years), the median event-free survival (EFS) for patients in the combination arm was 2 years (p=0.0063), while patients in the lenalidomide monotherapy arm achieved a median EFS of 1.2 years.
The most common grade 3-4 adverse events for patients receiving lenalidomide plus rituximab and lenalidomide monotherapy, respectively, were neutropenia (19% vs. 16%), fatigue (14% vs. 9%) and thrombosis (4% vs. 16%). The full treatment regimen was completed in 61% of combination and 36% of lenalidomide monotherapy patients, with the difference due to more progressions or non-responders in the lenalidomide monotherapy group. In the combination arm 18% of subjects discontinued therapy early due to AEs compared to 22% in the lenalidomide monotherapy arm.
These results are from an investigational study, REVLIMID is not approved for the treatment of follicular lymphoma.
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 patients with multiple myeloma (MM) who have received at least one prior therapy.
REVLIMID® (lenalidomide) is indicated for the 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.
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.
Pregnancy Category X:
WARNINGS AND PRECAUTIONS:
Reproductive Risk and Special Prescribing Requirements (RevAssist Program):
Hematologic Toxicity—Multiple Myeloma:
Deep Vein Thrombosis and Pulmonary Embolism:
Tumor Lysis Syndrome:
Tumor Flare Reaction:
Second Primary Malignancies
USE IN SPECIFIC POPULATIONS:
DOSAGE AND ADMINISTRATION:
Please see full Prescribing Information, including Boxed WARNINGS, CONTRAINDICATIONS, WARNINGS AND 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.
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