Study Presented at the American Society of Hematology Reports Revlimid Activity in Patients with Relapsed/Refractory Mantle-Cell Lymphoma

Encouraging Response to REVLIMID Reported in International Phase II Study of Heavily Pretreated Patients with Specific Type of Non-Hodgkins Lypmhoma

BOUDRY, Switzerland--(BUSINESS WIRE)--Dec. 8, 2008--Celgene International Sarl (NASDAQ: CELG) announced updated clinical data from the NHL-003 study, a 200 patient open label, multi-center study of patients with relapsed/refractory mantle cell lymphoma (MCL) who had received at least one prior therapy. The subset analysis of patients with MCL was presented during the 50th Annual Meeting of the American Society of Hematology. These data demonstrated that REVLIMID (lenalidomide) is active and well tolerated in patients with this very aggressive sub-type of non-Hodgkins lymphoma (NHL).

MCL is an aggressive form of blood cancer that makes up approximately six percent of all NHL cases; accounting for around 4,500 cases per year in the United States. This preliminary analysis of the NHL-003 data focuses on the 39 MCL patients that were enrolled in the trial and evaluable for response assessment at the time of data cut-off. These evaluable patients were heavily pretreated with a median number of three prior therapies.

"This study is encouraging because it demonstrates that REVLIMID is a safe and effective option for treating patients with MCL who have failed multiple prior therapies," said Pier Luigi Zinzani, M.D., Institute of Hematology and Medical Oncology, Bologna, Italy. "New treatment options are critical for this disease since most MCL patients are not cured by current therapies, and conventional chemotherapy typically results in short response durations and limited progression-free survival."

The study reported that the overall response rate (ORR) to single agent REVLIMID was 41 percent including 13 percent complete response or unconfirmed complete response (CR/CRu) and 28 percent partial response (PR). Another 26 percent of patients treated with REVLIMID had stable disease. The median progression free survival (PFS) was 7.1 months, and the median duration of response has not yet been reached. These results support the data previously reported from another phase II trial (NHL-002), in which the ORR and CR/CRu for 15 evaluable patients with MCL was 53 percent and 20 percent, respectively. The median duration of response seen in those patients was 13.7 months. The most common Grade 3 or 4 adverse events observed in MCL patients in the NHL-003 trial who received REVLIMID(R) were neutropenia (52%), thrombocytopenia (26%), anemia (13%), fatigue (10%) and febrile neutropenia (10%).

The company also reported pooled data on 14 MCL patients treated with REVLIMID from NHL-002 and NHL-003 who were previously treated with bortezomib, with seven of those patients being refractory to bortezomib. The data from this analysis demonstrated an ORR and CR of 57 percent and 21 percent, respectively, and a median PFS of 7.7 months. Bortezomib is the only drug approved in the US for patients with relapsed or refractory MCL and demonstrated an ORR and CR of 33 percent and 8 percent, respectively, in a pivotal study of patients with a median of one prior therapy.

"Patients with MCL are a particularly underserved population in need of new, effective treatment options," said Jean Pierre Bizarri, MD, Head of Global Clinical Oncology/Hematology for Celgene. "Based on these exciting Phase II results with REVLIMID in heavily pretreated MCL patients, Celgene has initiated a study which has undergone special protocol assessment - the EMERGE trial - in patients with relapsed/refractory MCL who have relapsed or progressed after treatment with bortezomib or are refractory to bortezomib and looks forward to presenting the results of this study at future meetings."

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(R) 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 Mantle-Cell Lymphoma

MCL is one of several subtypes of NHL and results from a malignant transformation of a B lymphocyte in the mantle zone - the outer edge of the lymph node follicles. The uncontrolled growth of the transformed lymphocytes, or lymphoma cells, cause tumors to form in the lymph nodes, which then become enlarged. Lymphoma cells can also spread to other tissues, such as the marrow, liver and gastrointestinal tract.

MCL is distinguished from other subtypes of B-cell lymphoma by abnormal expression of cyclin D1, a protein that stimulates cell growth. Approximately 85 percent of MCL cases are caused by genetic changes involving the cyclin D1 gene on chromosome 11 and chromosome 14.

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.

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.

 

 

CONTACT: Celgene International Sarl
Kevin Loth
Director of External Relations
+41 32 729 86 21

Source: Celgene International Sarl

Posted: December 2008

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