BOUDRY, Switzerland & PARIS (December 10, 2008) -- Celgene International Sarl (Nasdaq: CELG) and the Groupe d'Etude des Lymphomes de l'Adulte (GELA) today announced the initiation of an international randomized, double-blind, controlled Phase III study to evaluate the therapeutic potential of REVLIMID (lenalidomide) as a maintenance therapy for elderly, high-risk patients with diffuse large B-cell lymphoma (DLBCL) who have responded to standard first line Rituximab, Cyclophosphamide, Doxorubicin, Oncovin and Prednisolone (R-CHOP). Currently, there is no approved therapy proven to maintain remission after induction with R-CHOP therapy in patients with DLBCL. GELA is the leading Cooperative Group in the world for studying the treatment of adult lymphoma patients, and its work has helped establish the standard of care in the treatment of DLBCL, as well as other lymphoma histologies.
"Response rates seen to date are quite encouraging with REVLIMID monotherapy in heavily pretreated patients across a variety of lymphoma subtypes," said lead study investigator Professor Bertrand Coiffier, Head of the Department of Hematology, Hospices Civils de Lyon, France. "The response rates observed with REVLIMID combined with its unique profile as an oral, immunotherapeutic cancer agent provide the potential to significantly prolong the survival of these patients through a maintenance regimen."
This study, in which REVLIMID will be tested as an agent to prevent relapse after initial therapy, aims to advance the treatment of patients diagnosed with DLBCL, an aggressive form of non-Hodgkin's lymphoma (NHL). DLBCL is the most commonly diagnosed subtype of NHL with approximately 35,000 new cases diagnosed per year in the US and Europe. Most patients who relapse after initial treatment with standard chemotherapy tend to have a poor prognosis for long-term survival. The clinical benefits of REVLIMID, as a single agent in heavily pretreated patients across various histological subtypes of NHL, including DLBCL, continue to be reported in peer-reviewed publications and at major international medical meetings.
"We are excited that a premier research cooperative group, such as GELA, that has the resources and experience to choose any drug for its study, selected REVLIMID as the innovative therapy to advance treatment options for patients in need with aggressive lymphomas." said Jean Pierre Bizarri, M.D., Head of Global Clinical Oncology/Hematology for Celgene Corporation.
In this trial designed to enroll 621 patients, REVLIMID® will be administered daily three out of four weeks for 24 months (26 cycles) in patients responding to R-CHOP. Patients are expected to have received at least six cycles of R-CHOP regimens and up to eight cycles of R-CHOP repeated every two or three weeks according to local protocol. The primary objective of the study is to determine progression-free survival associated with REVLIMID maintenance compared to placebo in responding elderly patients with DLBCL treated in the first line with R-CHOP. The secondary objectives are to assess the percentage of patients who convert from partial response to complete response; the efficacy according to the response to R-CHOP; and the overall survival in both groups of patients, as well as safety.
REVLIMID is currently approved in the European Union, United States, Canada, Argentina and Switzerland in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy and in Australia in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy. REVLIMID is also approved in Canada, the United States and Argentina for transfusion-dependent anemia due to low- or intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. REVLIMID has obtained Orphan Drug designation in the EU, U.S., Switzerland, Australia and Japan.
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 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
Approximately 1.5 million people worldwide are living with various forms of lymphoma, and it is estimated that 300,000 people die each year. In terms of incidence and death, NHL is the second fastest growing cancer in the United States and the third fastest growing in the rest of the world.
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 NHL. Lymphomas generally are classified into two equal groups: half are indolent (low-grade) lymphomas while the remaining are aggressive (intermediate/high-grade). Intermediate/high-grade lymphomas spread rapidly, and left untreated, can be fatal within six months to two years.
Diffuse large B-cell lymphoma is the most common of the non-Hodgkin lymphomas, accounting for up to 30 percent of newly diagnosed cases. Diffuse large B-cell lymphoma is an aggressive, or fast-growing lymphoma. It can arise in lymph nodes or outside of the lymphatic system, in the gastrointestinal tract, testes, thyroid, skin, breast, bone or brain. Often, the first sign of diffuse large B-cell lymphoma is a painless or even painful rapid swelling in the neck, armpit or groin caused by enlarged lymph nodes. Other symptoms include night sweats, unexplained fevers and weight loss.
About GELA
The Groupe d'Etude des Lymphomes de l'Adulte (GELA), created in 1984 and headquartered in Lyon, France, is the largest cancer Cooperative Group devoted to adult lymphomas, with a fully integrated clinical research sister organisation (GELARC), around 500 members and more than 100 institutions throughout France, Belgium, Luxemburg, Switzerland and Portugal contributing to its studies. So far, these centers have included more than 25,000 patients in GELA's trials, which have been instrumental in improving adult lymphomas diagnostic and therapeutic approaches. For more information, please visit the group's website at www.gelarc.org.
About Celgene International Sarl
Celgene International Sarl, located in Boudry, in the Canton of Neuchatel, 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® and IMiDs® are registered trademarks of Celgene Corporation.
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 10K, 10Q and 8K reports.