REVLIMID® Data for Newly Diagnosed Multiple Myeloma Reported at a Satellite Symposium During the 13th European Hematology Association Congress

Data from the ECOG E4A03 and SWOG 0232 studies were reported at a Satellite Symposium and showed that newly diagnosed multiple myeloma patients who are eligible for a transplant, obtain better outcomes when treated with REVLIMID (lenalidomide) plus dexamethasone. The data were presented by Dr A. Stewart, from the Mayo Clinic at the 13th European Hematology Association (EHA) congress in Copenhagen, Denmark.

These data from the ECOG E4A03 and SWOG 0232 studies, which were recently presented at the American Society of Clinical Oncology (ASCO) Annual Meeting. More specifically, updated results from these two large cooperative group trials of REVLIMID in combination with dexamethasone in newly diagnosed patients reported a survival advantage and improved complete response rates for REVLIMID when combined with dexamethasone.

In a four–month landmark analysis of ECOG Phase III study E4A03, patients who continued on treatment of REVLIMID plus low–dose dexamethasone (Rd) achieved a two–year overall survival rate of 93 percent. In the same landmark analysis, patients who went on to autologous stem cell transplant achieved the same two–year survival rate of 93 percent.

Patients in the landmark analysis who received Rd achieved an overall response rate of 89 percent and CR + VGPR of 56 percent. Patients in the SWOG 0232 Phase III study receiving REVLIMID plus dexamethasone (RD) achieved a progression–free survival rate of 77 percent at one year and CR + VGPR of 62 percent.

Results from these studies demonstrate that REVLIMID in combination with dexamethasone is highly active in newly diagnosed multiple myeloma regardless of age or transplant eligibility. Moreover, results from the trials provide the rationale for conducting future prospective trials comparing novel agents to stem cell transplant.

"REVLIMID is turning multiple myeloma into a chronic disease through durable disease control, manageable side effects, and the freedom of oral dosing" commented Dr Brian Durie, Chairman of the Board and Co–Founder, International Myeloma Foundation (IMF).

Additional Data Support REVLIMID´s Efficacy in Newly Diagnosed Patients

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).

The Southwest Oncology Group also presented at ASCO 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