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REVLIMID(R) (lenalidomide) Study in Low and Intermediate-1 Risk Myelodysplastic Syndromes Presented at the 10th Congress of the European Hematology Association

- 51% of Eligible Low and Intermediate-1 Risk Transfusion Dependent Myelodysplastic Syndromes (MDS) Patients Without Deletion 5q Chromosomal Abnormality Achieve Hematologic Improvement, with 33% Achieving Transfusion Independence
- Transfusion Independence Maintained for a Median of 41 Weeks in Responders
- Median Hemoglobin Increased 3.2 g/dl From a Baseline of 8.0 g/dl in Responders
- 45% of Evaluable Patients Experience Cytogenetic Response
- Myelosuppression is Common and Manageable with Treatment Interruption and Dose Adjustment

STOCKHOLM, Sweden, June 6 /PRNewswire-FirstCall/ -- Celgene Corporation (Nasdaq: CELG - News) announced that REVLIMID clinical data were presented at a Scientific Session during the 10th Congress of the European Hematology Association (EHA). Alan List, M.D., Professor of Medicine and Program Leader, Hematologic Malignancies at H. Lee Moffitt Cancer Center, Tampa, Florida, presented results, based on available data as of March 31, 2005, in a multi- center Phase II trial evaluating REVLIMID in patients with Low and Intermediate-1 risk myelodysplastic syndromes.

At the 10th Congress of the EHA, REVLIMID clinical findings were presented in previously treated multiple myeloma, relapsed or refractory chronic lymphocytic leukemia, as well as the MDS-003 clinical trial results, which were highlighted during a plenary session at ASCO 2005.

"This data is consistent with the results from our prior trial MDS-001, and combined with the findings of the MDS-003 trial, it demonstrates the potential of REVLIMID for treating a broad range of patients with MDS," said Dr. List, the study's lead investigator. "I am delighted that the primary endpoint of this trial was achieved. In many patients, the response was accompanied by an unprecedented normalization of the bone marrow both histologically and cytogenetically."

About the Phase II Trial (MDS-002)

The analysis was based on clinical data available as of March 31, 2005. This trial will continue and be updated on an ongoing basis. Dr. List reported that 215 patients entered the study, of whom, 166 were documented to have Low to Intermediate-1 risk MDS. Of the patients who entered the study the median age was 72 years (range, 27-94). Forty-six patients remain on study. On a per- protocol analysis (eligible basis), eighty-four patients (51%) responded to treatment. Fifty-four patients (33%) became transfusion independent as defined by a more stringent modification of the MDS International Working Group (IWG) Response Criteria, requiring eight consecutive weeks without a blood transfusion and a 1g/dl or greater rise in hemoglobin. Thirty patients (18%) achieved a minor response, defined as a 50% or greater decrease in blood transfusion requirement. The median duration of transfusion-independence was 41 weeks. In addition, the median baseline hemoglobin level was 8.0 grams per deciliter. With REVLIMID® treatment, the median increase in hemoglobin was 3.2 grams per deciliter. Twenty patients were evaluable for cytogenetic response. Of these nine patients (45%) experienced cytogenetic remission.

Based on an intent-to-treat analysis, which accounts for all patients registered in MDS-002 as opposed to only patients meeting the specific inclusion criteria on a per-protocol basis, ninety-four patients (44%) responded to treatment. Fifty-eight patients (27%) became transfusion independent, defined according to International Working Group (IWG) as eight weeks without blood transfusion. Thirty-six patients (17%) achieved a minor response, defined as a greater than 50% decrease in transfusion dependence according to IWG criteria. The median duration of transfusion-independence was 43 weeks. The median increase in hemoglobin (Hgb) was 3.3 grams per deciliter.

The most common Grade three or higher adverse events were neutropenia (24%) and thrombocytopenia (19%). The most common non-hematologic adverse events for all National Cancer Institute Common Toxicity Criteria grades included rash (22%), pruritus (21%), constipation (14%), diarrhea (13%), and fatigue (12%). In the MDS-002 trial, twenty (9.3%) patients died; two (0.9%) infectious patient deaths were suspected by the local investigator to be possibly drug related.

"We are pleased that the clinical data from this trial were selected to be presented at a EHA Scientific Session. The results from this trial complement the data from MDS-003 that were recently presented at the American Society of Clinical Oncology that showed REVLIMID's activity in treating anemia in MDS patients with a del 5 q chromosomal defect. The presentation today shows REVLIMID's activity in a larger group of Low and Intermediate-1 risk MDS patients, who lack a distinct cytogenetic abnormality" said Jerome B. Zeldis, M.D., Ph.D., Chief Medical Officer and VP, Medical Affairs of Celgene.

About REVLIMID

REVLIMID is a member of a new class of novel immunomodulatory drugs, or IMiDs®. Celgene is evaluating treatments with REVLIMID for a broad range of hematology and oncology conditions, including; multiple myeloma, the malignant blood cell disorders known as myelodysplastic syndromes (MDS), chronic lymphocytic leukemia and solid tumor cancers. REVLIMID affects multiple intracellular biological pathways. The IMiD pipeline, including REVLIMID, is covered by a comprehensive intellectual property estate of U.S. and foreign issued and patent-pending applications including composition-of-matter and use patents.

REVLIMID is not approved by the FDA or any other regulatory agencies as a treatment in any indication and is currently being evaluated in clinical trials for efficacy and safety for future regulatory applications.

About Myelodysplastic Syndromes

Myelodysplastic syndromes (MDS) are a group of hematologic malignancies that affect approximately 300,000 people worldwide. Myelodysplastic syndromes occur when blood cells remain in an immature or "blast" stage within the bone marrow and never develop into mature cells capable of performing their necessary functions. Eventually, the bone marrow may be filled with blast cells suppressing normal cell development. According to the American Cancer Society, 10,000 to 20,000 new cases of MDS are diagnosed each year in the United States, with mean survival rates ranging from approximately six months to six years for the different classifications of MDS. MDS patients must often rely on blood transfusions to manage symptoms of anemia and fatigue until they develop life-threatening iron overload and/or toxicity, thus underscoring the critical need for new therapies targeting the cause of the condition rather than simply managing its symptoms.

About Celgene

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 http://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.

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Source: Celgene Corporation

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