BOUDRY, Switzerland, May 05, 2011 (BUSINESS WIRE) --
Celgene International Sàrl (NASDAQ: CELG) announced that updated data from a National Cancer Institute-sponsored clinical study were presented by representatives of a network of researchers led by the Cancer and Leukemia Group B (CALGB) at the 2011 International Myeloma Workshop in Paris, France.
As of April 2011, at a median follow-up of 28 months, patients receiving continuous REVLIMID (lenalidomide) following ASCT demonstrated a statistically significant improvement in overall survival (OS), with an OS rate of 90% (208/231) compared to 83% (190/229) for patients randomized to receive placebo (unadjusted p=0.018) HR 0.51 (95% CI = 0.26 to 1.014), despite nearly 80% (86/110) of patients crossing over to receive continuous lenalidomide at the time of study unblinding. Additional analyses presented by CALGB of the original OS data at time of study unblinding demonstrated an OS rate of 94% (218/231) in the continuous Revlimid arm compared to 89% (204/229) in the placebo arm (p=0.05).
At a median follow-up of 28 months, the median time to progression (TTP) was significantly higher for the lenalidomide arm at 48 months versus the median TTP of 30.9 months for the placebo arm (p<0.0001) HR 0.44 (95% CI = 0.32 to 0.60). This translated to a 56% reduction in the risk of disease progression in the lenalidomide arm. In prospectively defined subgroup analyses, TTP was significantly higher in all subgroups of patients that received continuous lenalidomide post ASCT. Within these subgroups TTP was longest in the group of patients that received lenalidomide both as induction therapy and continuous therapy following ASCT.
Also, at a median follow-up of 28 months, the median event-free survival for patients in the lenalidomide arm was 43.4 months, versus 30.9 months in the placebo arm (p<0.0001) with an estimated HR of 0.51 (95% CI = 0.38 to 0.68)
In this Phase III, controlled, double-blind, multi-center study, newly diagnosed multiple myeloma patients who achieved at least stable disease (SD) following autologous stem cell transplant (ASCT) were randomized to receive continuous daily treatment with lenalidomide 10 mg (n=231) or placebo (n=229) until relapse. The independent Data and Safety Monitoring Committee report of a planned interim analysis in November 2009 led to the announcement the study had met its primary endpoint and subsequently unblinded. The data are from a continuing analysis of the subjects post-unblinding through April 2011.
The most common grade 3-4 adverse events experienced by patients receiving lenalidomide or placebo in the study were neutropenia (43% 89/208 vs. 9% 17/197), thrombocytopenia (13% 26/208 vs. 4% 7/197) and infections (16% 33/208 vs. 5% 11/197). There were no grade 5 hematologic adverse events. The rate of grade 5 non-hematologic adverse events was similar between the two arms of the study (1% 3/208 vs. 2% 3/197).
An increase in second primary malignancies (SPMs), mainly hematological malignancies, was observed in patients receiving lenalidomide compared to patients receiving placebo. However, the event free survival analysis, where SPM was included as an event, in addition to death and progression, demonstrated that there was no significant impact of SPMs on the observed TTP or OS benefit.
The CALGB 100104 data are from an investigational study. REVLIMID® does not have marketing approval for the treatment of patients newly diagnosed 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 50 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 and several Latin American countries, as well as Malaysia and Israel, for transfusion-dependent anemia 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® (lenalidomide) is indicated for 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, 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.
Pregnancy Category X:
WARNINGS AND PRECAUTIONS:
Reproductive Risk and Special Prescribing Requirements (RevAssist Program):
Hematologic Toxicity--Multiple Myeloma:
Deep Vein Thrombosis:
Tumor Lysis Syndrome:
Tumor 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 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