Revlimid Data for Newly Diagnosed Multiple Myeloma Reported at a Satellite Symposium During the 13th European Hematology Association Congress
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 less than 0.002). Additionally, patients in the RD arm of the study had a progression-free survival rate of 77 percent after one year compared to 55 percent for dexamethasone (p=0.002). Overall survival for patients in the RD arm at one year was 93 percent compared to 91 percent for dexamethasone. These data were confounded by the fact that patients in the D arm were given the option to cross over into the RD arm after the study was halted early.
Grade 3/4 adverse events were more frequent in multiple myeloma patients who received the combination of lenalidomide/dexamethasone compared to dexamethasone alone. Neutropenia (13.8% vs. 2.4%) and infections (18.9% vs. 9.8%) were the most frequently reported adverse events. DVT occurred in 27% of patients receiving REVLIMID and dexamethasone compared to 14.6% with dexamethasone alone.
REVLIMID is an IMiDs(R) compound, a member of a proprietary group of novel immunomodulatory agents. REVLIMID and other IMiDs compounds continue to be evaluated in over 100 clinical trials in a broad range of oncological conditions, both in blood cancers and solid tumors. The IMiDs pipeline is covered by a comprehensive intellectual property estate of U.S. and foreign issued and pending patent applications including composition-of- matter and use patents.
About Multiple Myeloma
Multiple myeloma (also known as myeloma or plasma cell myeloma) is a cancer of the blood in which malignant plasma cells are overproduced in the bone marrow. Plasma cells are white blood cells that help produce antibodies called immunoglobulins that fight infection and disease. However, most patients with multiple myeloma have cells that produce a form of immunoglobulin called paraprotein (or M protein) that does not benefit the body. In addition, the malignant plasma cells replace normal plasma cells and other white blood cells important to the immune system. Multiple myeloma cells can also attach to other tissues of the body, such as bone, and produce tumors. The cause of the disease remains unknown.
About Celgene International Sarl
Celgene International Sarl, located in Boudry, Switzerland, is a wholly owned subsidiary and international headquarters of Celgene Corporation. Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company's website at www.celgene.com.
This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company's control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company's filings with the Securities and Exchange Commission such as Form 10-K, 10-Q and 8-K reports.
David Gryska, 908-673-9059
Sr. Vice President and Chief Financial Officer
Brian P. Gill, 908-673-9530
Vice President, Corporate Communications
Posted: June 2008