Overview of Venous Thromboembolism (VTE) in Nearly 100,000 Patients Treated with Revlimid® (lenalidomide).

Lenalidomide, an oral anti-proliferative and immunomodulatory drug, is indicated for the treatment of patients with multiple myeloma (MM) who have received at least one prior therapy and Myelodysplastic Syndrome (MDS) associated with deletion of 5q abnormalities and approved for use in over 40 countries. Venous thromboembolism (VTE) incidence in the general population is 100 per 100,000 person years in US, with 2/3 found as deep vein thrombosis (DVT) and 1/3 as pulmonary embolism (PE) [Heart Disease and Stroke Statistics 2007 update]. In all solid tumor patients incidence of VTE is 7% (Sallah S, Wan JY, Nguyen NP. Venous thrombosis in patients with solid tumors: determination of frequency and characteristics. Thromb Haemost 2002; 87: 575–579). The risk of VTE is increased by as much as 28-fold in patients with hematological cancer (Blom JW, et. al. Malignancy, prothrombotic mutations, and the risk of venous thrombosis. JAMA 2005; 293: 715–722).

This retrospective analysis evaluates the incidence of VTE in completed and ongoing clinical trials, company sponsored and investigator initiated as well as in the commercial use setting.

All patients enrolled in completed and ongoing company-sponsored trials, completed and ongoing investigator initiated trials (IIT), and patients who received lenalidomide (with or without dexamethasone) in the commercial use setting were included with a data cut-off date of June 30, 2009. VTE includes DVT and PE. However, only patients who received active drug (lenalidomide with or without dexamethasone) in ongoing and completed Celgene-sponsored trials were included in this analysis. This overview is based on treatment –emergent population which includes anyone receiving lenalidomide and reporting VTE irrespective of its causality assessment.

Overall, 99,769 patients were evaluated: 6,629 in company-sponsored trials, 7,497 in investigator initiated trials and 85,643 in the commercial use setting. The findings of these analyses will be presented and put into context of different disease states, differences between controlled clinical trials versus IIT and commercial setting use data on VTE with the use of lenalidomide.

Amongst evaluated subgroups, the incidence of VTE is comparable to that found within the cancer population as a whole. The incidence rate of VTE in those treated with lenalidomide monotherapy is lower compared to len/dex combination. High dose dexamethasone in combination with lenalidomide has a higher incidence of VTE than low dose dexamethasone with lenalidomide. Current VTE prophylaxis in patients receiving lenalidomide is based on common Oncology Medical Practices, which has not yet been studied in a prospective placebo controlled manner.

Weiss:Celgene Corporation: Employment, Equity Ownership. Off Label Use: Safety data analysis includes studies in indication that are not approved as well as safety data from commercial use label and off-label for Revlimid® (lenalidomide) is included. Shah:Celgene Corporation: Employment, Equity Ownership. Yiu:Celgene Corporation: Employment, Equity Ownership. Freeman:Celgene Corporation: Employment, Equity Ownership. Knight:Celgene Corporation: Employment, Equity Ownership. Zeldis:Celgene Corporation: Employment, Equity Ownership, Membership on an entity's Board of Directors or advisory committees.