BOUDRY, Switzerland, Dec 06, 2010 (BUSINESS WIRE) --
Celgene International Sàrl (NASDAQ: CELG) announced that data from the planned second interim analysis (median follow-up of 21 months) of a phase III, randomised, double-blind study of continuous REVLIMID® (lenalidomide) for the treatment of patients 65 years or older with newly diagnosed multiple myeloma show a clinically significant improvement in progression-free survival (PFS), the primary endpoint of the study. The data were presented at the annual meeting of the American Society of Hematology.
The study of 459 patients 65 years or older evaluated patients receiving lenalidomide in combination with melphalan and prednisone, followed by lenalidomide alone (MPR-R) (n=152); patients receiving lenalidomide in combination with melphalan and prednisone, followed by placebo (MPR) (n=153); and patients receiving placebo, melphalan and prednisone, followed by placebo (MP) (n=154).
Continuous lenalidomide therapy with MPR-R compared with fixed duration MP treatment resulted in a higher overall response rate (ORR; 77% vs. 50%, p < 0.001) as well as higher rates of complete response (14% vs. 4%, p < 0.001) and very good partial response (VGPR) or better (32% vs. 12%, p < 0.001). Median progression-free survival (PFS) of the MPR-R arm was 31 months, while the MP arm had a median PFS of 13 months (p < 0.0000001). Patients treated with MPR-R had a 60% reduction in the risk of disease progression compared to MP (hazard ratio [HR] = 0.398, p < 0.0000001), which is an improvement over the reduction in risk of disease progression reported at the first interim analysis in December 2009. In a separate analysis, patients treated with MPR-R had a 69% reduction in the risk of disease progression compared to those treated with MPR (hazard ratio [HR] = 0.314, p < 0.001).
PFS was also extended in patients receiving continuous lenalidomide therapy regardless of disease stage (stage I/II vs. III), kidney function (creatinine clearance greater-than or equal to 60 vs. < 60 mL/min), or baseline B2-microglobulin (less-than or equal to 5.5 vs. > 5.5 mg/L). In addition, regardless of induction response (greater-than or equal to VGPR or PR), patients who received continuous lenalidomide had longer PFS compared with placebo. Additionally, patients who relapsed in the MPR-R arm had similar second-line treatment duration (median 54 weeks) compared with those relapsing while on placebo following MP (median 54 weeks). Follow-up remains too short to identify significant overall survival differences between the three groups at time of reporting.
In the safety population (the patients who received at least one dose of therapy on study), the most common grade 4 haematological adverse events included neutropenia (36%, MPR-R vs. 8%, MP), thrombocytopenia (13%, MPR-R vs. 4%, MP) and anaemia (5%, vs. 1%, MP). Low rates of deep vein thrombosis (3% vs. <1%) and fatigue (6% vs. 3%) were observed. Grade 3 or 4 peripheral neuropathy was experienced by no patients in the MPR-R arm and 1% of patients in the MP arm.
These data are from an investigational study. REVLIMID is not approved as an initial treatment for patients with multiple myeloma.
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.
Pregnancy Category X:
WARNINGS AND PRECAUTIONS:
Reproductive Risk and Special Prescribing Requirements (RevAssist Program):
Hematologic 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, 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.
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