11-06-07
REVLIMID® DATA EVALUATING COMBINATION ORAL TREATMENT REGIMEN IN ELDERLY NEWLY DIAGNOSED MULTIPLE MYELOMA PATIENTS PRESENTED AT EUROPEAN HEMATOLOGY MEETING
New Clinical Data Reports 100% Response Rate for Elderly
Patients, After Two-Years of Follow-up
VIENNA, AUSTRIA - (June 11, 2007) – Celgene International Sárl (NASDAQ: CELG) announced that clinical data from a Phase I/II study evaluating combination therapy REVLIMID (lenalidomide), melphalan and prednisone (R-MP) in elderly newly diagnosed multiple myeloma patients were reported at an oral presentation during the 12th Congress of the European Hematology Association (EHA) in Vienna, Austria. The updated data reported that after two years, the overall survival rate was 91% with a 75% rate of event-free survival (EFS). Additionally, 100% of patients continued to respond with approximately 24% achieving a complete response (CR) and about 24% achieving at least a very good partial remission (VGPR) with the oral combination therapy R-PM.
"These results compare to autologous stem cell transplantation outcomes and could result in a change in the treatment strategy for elderly patients if confirmed by a phase III study evaluating the REVLIMID treatment combination versus transplantation", said Mario Boccadoro, M.D., Professor of Medicine, Director, Section of Hematology, University of Torino, Italy.
Multiple myeloma is the second most commonly diagnosed blood cancer. According to the International Myeloma Foundation, there are an estimated 750,000 people with multiple myeloma worldwide. There are more than 85,000 patients in Europe currently undergoing treatment for multiple myeloma, and 25,000 patients are expected to die from this blood cancer in 2007.
"This phase II study is very promising and we already have a phase III trial that is ongoing to confirm these results. If this is the case, the RMP combination will become the standard of care in newly diagnosed elderly patients" said Antonio Palumbo, M.D., Professor of Medicine, University of Torino, Italy.
REVLIMID has obtained Orphan Drug designation in the EU, US and Australia for treatment of Multiple Myeloma and is already approved by the U.S. Food and Drug Administration (FDA) for use as a treatment in combination with dexamethasone for previously treated multiple myeloma patients. REVLIMID is also approved in the US for treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities by the FDA.
About the Trial
This Phase I/II multi-center, dose-escalating, open-label trial was designed to evaluate the dosing, safety and efficacy of RMP in newly diagnosed symptomatic multiple myeloma patients aged 65 and older. Patients were treated with nine courses of lenalidomide (5-10 mg/day for 21 days every 4-6 weeks) plus MP (melphalan 0.18-0.25 mg/kg and prednisone 2 mg/kg for 4 days every 4-6 weeks). Four different dose levels were tested and all patients received aspiring as antithrombotic prophylaxis.
Fifty-three patients (median age 71, range 57-77) received at least one R-MP course. No DLTs were observed in the first 2 dose levels. In level 3 one patient experienced DLT (grade 4 neutropenia lasting> 7 days). In level 4 three patients showed DLTs (1 pt experienced neutropenic fever and grade 3 cutaneous toxicity, 1 pt had a pulmonary embolism and delayed cycle 2 due to neutropenia, 1 pt delayed cycle 2 due to hematological toxicity). After nine cycles of R-MP, CR was observed in 24% of patients, and VGPR was observed in 24% of patients, PR was observed in 33% of patients.
Grade 3/4 hematological toxicities included neutropenia (52.4%), thrombocytopenia (23.8%) and anemia (4.8%). Grade 3/4 non-hematological toxicities included cutaneous (9.5%) and infections (9.5 %).and thromboembolism (5.7%); however, two of the three thromboembolic events occurred after aspiring discontinuation.
About REVLIMID®
REVLIMID is an IMiDs® compound, a member of a proprietary group of novel immunomodulatory agents. REVLIMID and other IMiDs compounds continue to be evaluated in over 75 clinical trials in a broad range of hematological and oncological conditions. The IMiDs pipeline is covered by a comprehensive intellectual property estateof issued and pending patent applications in the US, EU and other regions, 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 Sárl
Celgene International Sárl, located in Neuchâtel, 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.
REVLIMID® is a registered trademark of Celgene Corporation.