BOUDRY, SWITZERLAND - (December 8, 2008) – Celgene International Sàrl (NASDAQ: CELG) announced updated clinical data from an ongoing REVLIMID (lenalidomide) study of patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) during the 50th Annual Meeting of the American Society of Hematology. This data comes from the NHL-003 study, a Phase II open label, multi center study of single agent REVLIMID in patients with relapsed or refractory aggressive non-Hodgkins lymphoma (NHL) who had received at least one prior therapy. The data from the subset of patients with DLBCL demonstrates the safety and efficacy of REVLIMID in patients with this aggressive sub-type of NHL.
DLBCL is an aggressive form of NHL. As the most common sub-type of NHL, DLBCL accounts for approximately one third of all newly diagnosed NHL cases.
"Relapsed or refractory patients with this form of NHL who are not cured by standard treatments usually have a dismal prognosis," said Myron Czuczman, M.D., Chief of Myeloma/Lymphoma Service, Roswell Park Cancer Institute. "They are usually left with limited therapeutic options which provide very short durations of remission. This makes the finding that REVLIMID monotherapy is a safe and active treatment for these patients particularly important."
This preliminary subset analysis focused on the 73 DLBCL patients who were enrolled in the NHL-003 trial and evaluable for response assessment at the time of data cut-off. The evaluable patients were heavily pretreated, with a median number of three prior therapies.
The overall response rate (ORR) to single agent REVLIMID was 29 percent, with a complete response (CR) rate of four percent. Median duration of response was 4.4 months at an early study follow-up and improved to 7.0 months in a more recent follow-up. Another 15 percent of patients treated with REVLIMID had stable disease. The results support the data previously reported from another phase II trial (NHL-002), in which the ORR for 26 evaluable patients with DLBCL was 19 percent, with a median duration of response of 7 months.
The most common Grade 3 or 4 adverse events observed in patients in the NHL-003 trial who received REVLIMID® were neutropenia (31%) and thrombocytopenia (15%).
Earlier today, the company also announced that the Groupe d'Etude des Lymphomes de l'Adulte (GELA) has selected REVLIMID for a Phase III study as a maintenance therapy for elderly, high-risk patients with diffuse large b-cell lymphoma (DLBCL) who have responded to standard first line R-CHOP chemotherapy. 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.
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 and Australia and Japan.
About REVLIMID
REVLIMID is an IMiDs® compound, a member of a proprietary group of novel immunomodulatory agents. REVLIMID and other IMiDs continue to be evaluated in over 100 clinical trials in a broad range of hematological and oncological conditions. The IMiDs pipeline is covered by a comprehensive intellectual property estate of issued and pending patent applications in the US, EU and other regions, including composition-of- matter and use patents.
About Non-Hodgkin 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 outside of lymph nodes within lymphatic tissues located in organs such as the stomach or intestines. They may involve the marrow and the blood in some cases as well. There are many different kinds of non-Hodgkin's lymphoma (NHL). There are an estimated 360,000 patients with NHL in the U.S. with more than 63,000 new patients diagnosed annually.
About Celgene International Sàrl
Celgene International Sàrl, located in Boudry, in the Canton of 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.
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.