Revlimid clinical data in newly diagnosed multiple myeloma presented

Celgene Corporation announced today that data evaluating clinical results on Revlimid (lenalidomide) as a new therapeutic approach for patients with newly diagnosed multiple myeloma (MM) was presented at the American Society of Hematology 46th Annual Meeting in San Diego.

Multiple myeloma is the second most common blood cancer in the United States affecting approximately 50,000 people. About 14,600 new cases of multiple myeloma are diagnosed each year and about 10,800 Americans (5,500 men and 5,300 women) are expected to die of multiple myeloma in 2004.

This Phase II trial was led by Vincent Rajkumar, M.D., a Mayo Clinic hematologist and oncologist. Dr. Rajkumar presented the initial results of this first Phase II trial using the combination of Revlimid plus dexamethasone with low dose (81 mg) aspirin as initial therapy for newly diagnosed MM. The median age was 64 years (range, 32-78). Twenty five of 30 patients achieved an objective response yielding a response rate of 83%. Ten patients (33%) have experienced grade 3 non-hematologic adverse events. These include one episode each of CD4-count < 200/mm3, anemia, neutropenia, increased liver enzymes, muscle weakness, agitation, hyperglycemia, cardiac arrhythmia, pneumonitis, erlichiosis, and colonic perforation. Notably, no deep vein thrombosis and no grade 4 or higher adverse events have been observed so far.

"These Phase II results suggest that oral combination therapy lenalidomide and dexamethasone (Rev/Dex) offer clinical benefit and is well tolerated in the treatment of newly diagnosed MM," explained Dr. Rajkumar. "A large randomized trial using Revlimid/Dexamethasone has recently started and is being conducted by the Eastern Cooperative Oncology Group."

The trial was designed to accrue 34 eligible patients; the first 30 consecutive patients (19 male and 11 female) were analyzed in this interim report. Patients were enrolled between February 2004 and July 2004. Revlimid was given orally at a dose of 25 mg daily on days 1-21 of a 28-day cycle. Dexamethasone was given orally at a dose of 40 mg daily on days 1-4, 9-12, 17-20 of each cycle. Patients also received an aspirin once daily as thrombosis prophylaxis. Response was defined as a decrease in serum monoclonal (M) protein by 50% or higher and a decrease in urine M protein by at least 90% or to a level less than 200 mg/24 hours, and needed to be confirmed by two readings at least 4 weeks apart. Responses were assessed on an intent-to-treat basis.

Revlimid is a member of a new class of novel immunomodulatory drugs, or IMiDs(R) which may demonstrate, in clinical studies, anticancer response. Nearly 30 clinical trials are evaluating Revlimid in the treatment of a broad range of conditions, including; multiple myeloma, the malignant blood cell disorders known as myelodysplastic syndromes (MDS) as well as solid tumor cancers. Revlimid is believed to affect multiple biological pathways within the cell, which ultimately may be responsible for the clinical response observed in multiple cancer studies. The IMiD pipeline, including Revlimid, is covered by a comprehensive intellectual property estate of U.S. and foreign issued patents and pending patent applications including composition-of-matter and use patents.

Revlimid (lenalidomide) 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.

Multiple myeloma (also known as myeloma or plasma cell myeloma) is a cancer of the blood in which malignant plasma cells are overproduced in the bone marrow. Plasma cells are white blood cells that help produce antibodies called immunoglobulins that fight infection and disease. However, most patients with multiple myeloma have cells that produce a form of immunoglobulin called paraprotein (or M protein) that does not benefit the body. In addition, the malignant plasma cells replace normal plasma cells and other white blood cells important to the immune system. Multiple myeloma cells can also attach to other tissues of the body, such as bone, and produce tumors. The cause of the disease is unknown. Multiple myeloma is the second most common cancer of the blood, representing approximately one percent of all cancers and two percent of all cancer deaths with a worldwide prevalence of approximately 200,000 cases. In the year 2002, there were an estimated 74,000 new cases of multiple myeloma worldwide. The estimated number of deaths from multiple myeloma in 2002 was 57,370 worldwide.

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