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.
Source: Celgene International Sàrl