BOUDRY, Switzerland, Jun 17, 2011 (BUSINESS WIRE) --
Celgene International Sàrl (NASDAQ: CELG) announced that clinical data from a Phase II study, conducted by investigators from the MD Anderson Cancer Center in Houston, TX, evaluating the combination regimen of REVLIMID (lenalidomide) plus rituximab (R2) in untreated, advanced stage, indolent B-cell non-Hodgkin's lymphomas, were presented at the 11th International Conference on Malignant Lymphoma in Lugano, Switzerland.
Patients entering the study included 45 with follicular lymphoma (FL), 24 with marginal zone lymphoma and 24 with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The age range was 35 to 84. Patients in the study received 20 mg/day of REVLIMID on days one to 21, and 375mg/m2 of rituximab on day one of each 28 day cycle for six cycles. The study has been amended to allow patients deriving clinical benefit to remain on study for up to 12 cycles. Of the 93 patients who could be evaluated for a response, the overall response rate (ORR) was 91% and the complete response rate (CR) was 65%. Additionally, the 24-month progression-free survival rate was 86%.
Looking specifically at the follicular lymphoma patients, 85% (38/44) evaluable FL patients achieved a complete response. When categorized by the Groupe d'Etudes des Lymphomes Folliculaires (GELF) criteria, CR and unconfirmed CR rates (Cru) were 95% in patients who met the GELF criteria for treatment, and 78% in patients who did not. After six cycles nearly all FL patients demonstrated a molecular response (BCL-2 proto-oncogene translocation not detectable by PCR).
Four patients experienced disease progression at a median follow-up of 14.4 months. For the total study population, the most common grade 3 non-hematological toxicities included eight cases with rash (9%), seven cases of muscle pain (8%), and three cases each of thrombosis and infection (3% each). Grade 3 neutropenia occurred in 25 patients (27%) and there were four cases of grade 3 thrombocytopenia (4%). Five patients (5%) stopped treatment due to adverse events, all within the first two cycles of treatment.
The results of this study have encouraged plans for a multi-national, phase III trial investigating the R2 combination compared to standard chemoimmunotherapy regimens in newly diagnosed FL (the RELEVANCE trial). This trial is designed to validate the concept of using REVLIMID to enhance ADCC (antibody-dependent cell-mediated cytotoxicity) in patients being treated with rituximab.
These data are from investigational studies. REVLIMID does not have marketing approval for the treatment of non-Hodgkin's lymphoma.
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 United States, Canada, Japan 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.
Important Safety Information
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.
Pregnancy Category X:
WARNINGS AND PRECAUTIONS:
Reproductive Risk and Special Prescribing Requirements (RevAssist Program):
Haematologic Toxicity--Multiple Myeloma:
Deep Vein Thrombosis:
Tumour Lysis Syndrome:
Tumour Flare Reaction:
USE IN SPECIAL POPULATIONS:
DOSAGE AND ADMINISTRATION:
Please see full Prescribing Information, including Boxed WARNINGS, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, and ADVERSE REACTIONS.
About Follicular Lymphoma
Follicular lymphoma is a common type of non-Hodgkin's lymphoma (NHL), accounting for about one in four of all cases. It can occur at any time during adulthood, though people are typically diagnosed during their sixties, and affects as many men as it does women. It is a low-grade lymphoma, which means that while it usually develops slowly, the disease is considered incurable, as nearly all patients who respond to initial treatment will ultimately relapse.
About ADCC (antibody-dependent cell-mediated cytotoxicity)
ADCC is an immune defense mechanism that directs natural killer cells, T cells, macrophages and other immune cells to cause cancer cell death. Antibodies such as rituximab target receptors on lymphoma cells to induce ADCC. In addition to being an immunomodulatory agent with direct and indirect cancer activity, Revlimid may also enhance the ADCC process against cancer cells.
About Celgene Risk-Management
Celgene continues to be a pioneer in creating environments in which patients who can benefit from our disease-altering therapies are able to do so, and do so safely. We are fully committed to drug lifecycle safety, from clinical development to post-marketing surveillance. As a result, patients worldwide continue to benefit from our risk-management programs such as, S.T.E.P.S.®, RevAssist®, RevMate® and PRMP, which form the global foundation of our commitment to patient safety.
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