June 14, 2008
Preliminary Results From International Study Report That REVLIMID(R) Provides Responses for Patients With Relapsed/Refractory Aggressive Non-Hodgkin’s Lymphoma
Celgene International Sarl (Nasdaq:CELG) today announced that preliminary data from an international study of single agent REVLIMID (lenalidomide) in relapsed/refractory aggressive non-Hodgkin's lymphoma (NHL) were presented at the 13th Congress of the European Hematology Association (EHA) in Copenhagen, Denmark.
In this study of heavily pretreated patients, 83 were eligible for response evaluation. An objective response was observed in 29 percent of patients, with six percent achieving a complete response (CR/CRu), 23 percent achieving a partial response and 19 percent showing stable disease.According to NHL histology, objective response was 36 percent in mantle cell lymphoma, 22 percent in diffuse large b-cell lymphoma, 33 percent in follicular lymphoma (grade three) and 50 percent in transformed lymphoma. These responses included several patients that had been refractory to their prior therapies, including rituxamab based regimens.
In the study, the most common grade 3 or higher adverse events were neutropenia (27%), thrombocytopenia (15%), leucopenia (5%), anemia (8%) and fatigue (5%).
"These data demonstrate that lenalidomide has activity in relapsed/refractory aggressive NHL with a favorable safety profile," said Myron Czuczman, MD, Head, Lymphoma/Myeloma Section, Department of Medicine at Roswell Park Cancer Institute and lead author of the study. "Early results from this large international study appear to confirm the results obtained from a previous, smaller, U.S.-based phase II study."
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 Non-Hodgkin's Lymphoma
Lymphoma is the name for the group of blood cancers that start in the lymphatic system, which is part of the body's immune system. Lymphomas generally start in the lymph nodes or lymphatic tissue in sites of the body such as the stomach or intestines. They may involve the marrow and the blood in some cases as well. Most people with lymphoma have one of the many different kinds of non-Hodgkin's lymphoma (NHL).
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.