BOUDRY, Switzerland--(December 10, 2008)--Celgene International Sarl (Nasdaq:CELG) today announced more mature data from clinical studies of REVLIMID (lenalidomide) in newly-diagnosed multiple myeloma were presented at a joint symposium of the American Society of Clinical Oncology (ASCO) and the American Society of Hematology (ASH) on Sunday, Dec. 7. The results from the ECOG E4A03 study of REVLIMID plus low-dose dexamethasone (Rd) versus REVLIMID plus a standard dose of dexamethasone (RD) in newly diagnosed multiple myeloma patients detailed some of the highest three-year overall survival rates ever reported in the intent to treat population. These results showed a three-year survival rate of 75 percent in the RD arm of the study and 74 percent in the Rd arm.
Additionally, in a Landmark Analysis where patients were treated continuously with Rd therapy as opposed to stem cell transplant, patients achieved an overall response rate of 91 percent with a 57 percent complete response plus very good partial response rate (CR + VGPR).
Grade 3 or higher non-hematologic toxicities in the RD vs. Rd arms of the study included deep vein thrombosis (DVT)/pulmonary embolism (PE) (26% vs. 12%) infection/pneumonia (16% vs. 9%) cardiac ischemia (3% vs. 0.5%) and neuropathy (2% in both arms).
"These further data from the E4A03 study reinforce our view that REVLIMID plus low-dose dexamethasone has high activity and is well-tolerated long-term therapy in newly diagnosed multiple myeloma," said Mohamad Hussein, M.D., Vice President, Medical Affairs, Hematology for Celgene. "Additionally, the impressive data from the Landmark Analysis underscores the need to treat continually to control residual disease and improve outcomes."
REVLIMID is currently approved in the European Union, United States, Canada, Argentina and Switzerland in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy and in Australia in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy. REVLIMID is also approved in Canada, the United States and Argentina 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. REVLIMID has obtained Orphan Drug designation in the EU, U.S., Switzerland and Australia and Japan.
Source: Celgene International Sàrl