Updated REVLIMID® Data Presented in Newly Diagnosed Multiple Myeloma Presented at the 2008 American Society of Clinical Oncology (ASCO) Meeting

Celgene International Sàrl (Nasdaq:CELG) today announced physicians from leading cancer research centers presented data at the American Society of Clinical Oncology from several clinical studies of REVLIMID (lenalidomide) in multiple myeloma. Among these were updated results from two large cooperative group trials of REVLIMID in combination with dexamethasone in newly diagnosed patients. Both studies reported a survival advantage and improved complete response rates for REVLIMID when combined with dexamethasone.

In a study conducted by the Eastern Cooperative Oncology Group (E4A03) of REVLIMID plus low–dose dexamethasone (Rd) versus REVLIMID plus a standard dose of dexamethasone (RD) in newly diagnosed multiple myeloma patients, clinicians reported complete response rates that had not been tabulated at previous presentations. Patients in the Rd arm of the study demonstrated a combined near complete response/very good partial response (nCR/VGPR) rate of 52 percent in the Rd arm compared to 42 percent in the RD arm (P=0.06). Also reported was a two–year overall survival of 88 percent for the Rd arm compared to 78 percent in the RD arm (p=0.007).

Grade 3 or higher non–hematologic toxicities in the RD vs. Rd arms of the study included deep vein thrombosis (DVT)/pulmonary embolism (PE) (25% vs. 11%) infection/pneumonia (16% vs. 8%) cardiac ischemia (3% vs. 0.5%) and neuropathy (2% in both arms).

Importantly, in a four–month landmark analysis of 255 patients who continued therapy after four cycles of treatment in the study, patients receiving Rd had a two–year overall survival rate of 93 percent compared to 82 percent for patients receiving RD (p=0.073). Patients receiving either RD or Rd in the analysis who moved on to autologous stem cell transplant also achieved a two–year overall survival of 93 percent. Patients receiving Rd in the landmark analysis also had an overall response (OR) rate of 89 percent, complete response (CR) rate of 22 percent and a CR/VGPR rate of 56 percent. The duration of response for these patients was 25 months.

The Southwest Oncology Group also presented updated results of a study (SWOG 0232) evaluating REVLIMID plus dexamethasone (RD) versus dexamethasone (D) alone in newly diagnosed multiple myeloma patients. Highlighted in the presentation was a combined complete response rate (CR) plus very good partial response rate (VGPR) of 62 percent for RD compared to 19 percent for dexamethasone (p