BOUDRY, Switzerland, Jun 05, 2010 (BUSINESS WIRE) --Celgene International Sàrl (NASDAQ: CELG) today announced results of a Phase II study of pomalidomide and dexamethasone in multiple myeloma patients who have failed both lenalidomide and bortezomib. Data were presented by Dr. Martha Lacy of the Mayo Clinic during the American Society of Clinical Oncology annual meeting.
Patients with multiple myeloma who have progressed after multiple therapies have limited treatment options. Pomalidomide, in an earlier report, demonstrated responses in relapsed multiple myeloma patients refractory to lenalidomide. Patients refractory to bortezomib were not evaluated in the earlier report (Lacy et al. ASH 2009. Abstract #429).
In this current analysis of the study, patients who were refractory to both lenalidomide and bortezomib were given 2mg daily of pomalidomide on days 1-28 of each 28-day cycle and 40mg daily of oral dexamethasone on days 1, 8, 15, 22.
The overall response rate (ORR) for these patients was 54% (19/35). Fourteen percent (5/35) of patients achieved a very good partial response (VGPR), 17% achieved a partial response (PR) (6/35) and 23% achieved a minor response (MR) (8/35). Additionally, at 6-month follow-up, the progression-free survival rate was 58% (95% CI: 42-80) and the overall survival rate was 86% (95% CI 73-100). The median progression-free survival was 8 months (95% CI: NA)
The most common grade 3 or 4 hematologic adverse events were neutropenia (34% 12/35), anemia (9% 3/35) and thrombocytopenia (9% 3/35).
These data are from an investigational study of pomalidomide, which is not approved for marketing.
Pomalidomide is an IMiDs® compound, a member of a proprietary group of novel immunomodulatory agents. These immunomodulatory agents, taken orally, have unique multiple mechanisms of action that involve the microenvironment of the cancer cell, not just the malignant cell itself. The IMiDs pipeline is covered by a comprehensive intellectual property estate of issued and pending patent applications in the US, EU and other regions.
About Multiple Myeloma
Multiple 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. Most patients with multiple myeloma, however, have cells that produce a form of immunoglobulin called paraprotein (or M protein), which 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.
This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company's control. The Company's actual results, performance, or achievements could be materially different from those projected by these forward-looking statements.The factors that could cause actual results, performance, or achievements to differ from the forward-looking statements are discussed in the Company's filings with the Securities and Exchange Commission, such as the Company's Form 10-K, 10-Q and 8-K reports.Given these risks and uncertainties, you are cautioned not to place undue reliance on the forward-looking statements.
SOURCE: Celgene International Sàrl
Celgene International Sàrl
Kevin Loth, +41 32 729 86 21
Director of External Relations