Patients Receiving Continuous Treatment with Lenalidomide (Revlimid? ) Experienced a 56% Reduction in the Risk of Disease Progression or Death Compared to Placebo (p<0.0001). This was reported earlier today by Swiss pharmaceutical company Celgene International S?rl. The company 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)

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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.

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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. Lenalidomide does not have marketing approval for the treatment of patients newly diagnosed with multiple myeloma.

Lenalidomide is an IMiDs? compound. The drug 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.

Lenalidomide 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.

Lenalidomide 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.

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