Phase II Study Evaluates Clinical Benefit of Pomalidomide in Heavily Pre-Treated Patients with Multiple Myeloma

Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG), announced that its oral therapy pomalidomide was evaluated as a potential treatment for patients with relapsed and refractory multiple myeloma who have received prior therapy that includes REVLIMID (lenalidomide) and bortezomib. The clinical data were presented at the 53rd Annual Meeting of the American Society of Hematology in San Diego, CA.

The trial, MM-002, was a randomized open-label Phase II study evaluating pomalidomide plus low-dose dexamethasone versus pomalidomide alone in relapsed and refractory multiple myeloma patients. Pomalidomide, with or without low-dose dexamethasone, was given in 28-day cycles: pomalidomide 4 mg once daily on days 1-21 every 28 days, and low-dose dexamethasone (40 mg) weekly.

Results presented were based on investigator-assessed responses for the intent-to-treat population. A total of 221 patients were enrolled in the study, and 191 patients were available for response. The study showed that out of 191 evaluable patients, partial response (PR) or better was seen in 34% of patients treated with pomalidomide plus low-dose dexamethasone compared with 13% of patients treated with pomalidomide alone.

Objective responses (minor response or better) were observed in 45% of patients treated with pomalidomide plus low-dose dexamethasone compared with 29% in the pomalidomide-only arm. Median progression-free survival, the primary end point of the study, was 4.7 months in the pomalidomide plus low-dose dexamethasone arm compared with 2.7 months in the pomalidomide-alone arm. Median duration of response (DOR) was 7.9 months in the pomalidomide plus low-dose dexamethasone arm compared with 8.5 months with pomalidomide alone, and median overall survival was 16.9 months compared with 14 months, respectively. Similar results were observed in all subsets of patients, including patients refractory to lenalidomide and patients refractory to both lenalidomide and bortezomib. Results from the independent adjudication were similar.

Patients in both arms of the study had been heavily treated prior to enrollment, with a median of 5 (range, 2 to 13) prior therapies. More than 74% and 76% of patients in the pomalidomide plus low-dose dexamethasone arm and pomalidomide alone arm, respectively, had undergone autologous stem cell transplantation.

Discontinuation rate due to adverse events was 6% in the pomalidomide plus low-dose dexamethasone arm, compared with 12% in the pomalidomide alone arm. The most common grade 3 or 4 adverse events in the pomalidomide plus low-dose dexamethasone arm versus pomalidomide alone were neutropenia (38% and 45%, respectively), anemia (21%, 17%), pneumonia (19%, 8%), thrombocytopenia (19%, 21%), and fatigue (10%, 8%).

These data are from an investigational study. Pomalidomide is not an approved product for any indication.

About Multiple Myeloma

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 remains unknown.

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.

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