BOUDRY, Switzerland, Dec 04, 2010 (BUSINESS WIRE) --
Celgene International Sàrl (NASDAQ: CELG) announced that clinical data from two investigational studies evaluating the use of REVLIMID® (lenalidomide) either with rituximab or following a rituximab-containing regimen in patients with chronic lymphocytic leukaemia (CLL) were presented at the 52nd American Society of Hematology annual meeting.
In the first study, 38 of 44 patients with previously untreated CLL received six cycles of pentostatin (2 mg/m2), cyclophosphamide (600 mg/m2) and rituximab (375 mg/m2) (PCR) every 21 days. Following this treatment regimen, 34 patients continued to consolidation therapy with lenalidomide starting at 5 mg per day, escalating to 10 mg per day as tolerated for a median of seven cycles.
At a median follow-up of 21 months, 91% (40/44) of patients were still alive, and 21% (7/34) of patients who received at least one cycle of lenalidomide consolidation showed an improvement in the quality of their response, including three patients who converted from minimal residual disease (MRD)-positive to MRD-negative disease. The median duration of response has not been reached.
Additionally, a comparison of these data against historic PCR data showed the proportion of patients receiving consolidation who were free of retreatment at 12 months was 95% (42/44), compared to 86% (55/64) of patients without lenalidomide consolidation in the historic study.
For patients receiving lenalidomide consolidation treatment in the study, the most common grade 3 or higher adverse events were neutropenia (grade 3, 41% 14/38; grade 4, 21% 7/38), leukopenia (grade 3, 32% 11/38), platelet count decrease (grade 3, 9% 3/38) and rash (grade 3, 6%, 2/38).
In the second study, 59 patients with relapsed/refractory CLL received rituximab 375 mg/m2 intravenously weekly for four weeks in cycle one, then once every four weeks during cycles three through 12. Oral lenalidomide 10 mg/day was started on day nine of cycle one on a continuous dosing schedule. Cycles were 28 days, with intention to continue therapy for 12 cycles or longer if the patient achieved a clinical response. Dose reductions were made following grade 3 or 4 lenalidomide-related adverse events, and allopurinol 300 mg daily was prescribed during the first two weeks as tumour lysis syndrome prophylaxis.
All 59 patients were evaluable for response, with evaluations performed after cycles three, six, and every six cycles thereafter. In the study, the overall response rate was 63% (37/59), with 5% (3/59) achieving a complete response. Additionally, 2% of patients (1/59) achieved a complete response with incomplete haematological recovery. 14% of patients (8/59) achieved nodular partial responses and 42% (25/59) achieved partial responses. Most responses (59%, 35/59) occurred within the first six cycles of therapy.
During the study, the highest incidences of grade 3/4 adverse events were neutropenia (68%, 40/59), thrombocytopenia (22%, 13/59) and anaemia (10%, 6/59). Grade 3/4 infections occurred in 18 patients (31%), mostly in the upper respiratory tract. One patient experienced grade 3 tumour lysis syndrome. One treatment-related death occurred during the study due to ischemic stroke with infection.
These data are from an investigational study. Lenalidomide is not approved as a treatment for patients with chronic lymphocytic leukaemia.
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):
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, 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.
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