BOUDRY, Switzerland - (December 7, 2008) - Celgene International Sàrl (NASDAQ: CELG) reported two REVLIMID (lenalidomide) Phase II studies, presented today at the 50th American Society of Hematology Meeting, both demonstrated high response rates and manageable side effects in patients previously untreated with symptomatic chronic lymphocytic leukemia (CLL). The studies demonstrated greater than 90 percent disease control across all evaluable patients.
The first CLL trial, presented by Alessandra Ferrajoli, M.D., Assistant Professor of Medicine at M.D. Anderson Cancer Center in Houston, Texas had 45 patients eligible for response (at least three cycles). These patients were previously untreated, symptomatic and ≥65 years of age (median age = 71). The preliminary results from this trial demonstrated that REVLIMID induced a rapid reduction in circulating lymphocytes with a 52 percent response rate including 29 percent blood complete responses (CR) and 6 percent nodular partial responses (after cycle nine). The study demonstrated that the REVLIMID response rates improve with continued treatment. Of 33 patients that completed nine cycles of therapy, four have progressed.
CLL is a disease of the elderly with a median age of 72 at the time of diagnosis according to the U.S. National Cancer Institute. Despite elderly patients representing the largest segment living with the disease, they are generally underrepresented in clinical trials and a satisfactory frontline treatment strategy for this group has not been defined. The population in this trial is representative of the broader population in CLL.
"Based on the clinical efficacy of REVLIMID demonstrated in patients with relapsed or refractory CLL, we wanted to evaluate its efficacy and tolerability as an initial treatment for older patients, for which the best treatment strategy is unknown," said Dr. Ferrajoli. "The early results indicate that REVLIMID given as continuous therapy at a starting dose of 5 mg per day followed by slow dose escalation is active, as well as safe and well-tolerated in this patient group."
In the study, patients were eligible if they were age 65 or older and met the criteria for treatment according to the 1996 NCI-WG guidelines. All patients received REVLIMID® orally at a dose of 5 mg daily for the first 56 days. After this time, the dose could be increased by 5 mg increments every 28 days to reach a maximum dose of 25 mg daily. Allopurinol at 300 mg daily was administered from day one to 14 as a tumor lysis prophylaxis.
Side effects were manageable and the most common hematological Grade 3/4 adverse event observed in this trial was neutropenia (27%). Growth factors were not routinely used. Additionally, tumor flare reactions were observed in 46 percent of patients and most were limited to Grade 1/2 and managed with oral steroids. Tumor lysis syndrome was not observed.
The results of a separate Phase II study were presented by Christine Chen, M.D., Assistant Professor at Princess Margaret Hospital in Toronto, Canada. In this 25-patient study of patients with previously untreated CLL, utilizing a 2.5 mg starting dose of REVLIMID on days 1-21 of a 28-day cycle, Dr. Chen reported 96 percent disease control. Based on her preliminary results, there was a 56 percent partial response rate and 20 percent blood CRs. Only one patient progressed to date.
"Preliminary results from this Phase II study suggest that REVLIMID is highly active in previously untreated CLL patients," said Dr. Chen.
No cases of tumor lysis syndrome were noted, and tumor flare and myelosuppression were manageable. The most common hematological Grade 3/4 adverse events observed in this trial were neutropenia (64%) and thrombocytopenia (12%). Seven patients required intermittent granulocyte colony-stimulating factor (GCSF) support (none received routine growth factor support). Based on the data presented today, Celgene plans to open a global Phase III Registration Trial in untreated symptomatic elderly CLL patients in 2009.
Celgene initiated the REVLIMID CLL registration program in 2008. The CONTINUUMTM trial initiated in September and was reviewed by the FDA SPA procedure. This trial is studying the use of REVLIMID as a maintenance therapy for those patients who received a response through their second-line treatment. The study will be a global trial.
CLL affects more people than any other type of leukemia. There are approximately 174,000 people living with CLL in the United States and Europe and over 35,000 new cases will be diagnosed this year.
REVLIMID is currently approved in the European Union, the 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 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 Chronic Lymphocytic Leukemia
CLL is one of the four main types of leukemia, and there are more people living with CLL than any other type of leukemia. CLL starts with a change to a single cell called a lymphocyte. Over time, the CLL cells multiply and replace normal lymphocytes in the marrow and lymph nodes, crowding out normal blood-forming cells and not allowing the body to fight infection.
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 biopharmaceutical 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 10K, 10Q and 8K reports.