New drug: Pomalidomide Phase II results
From the Celgene web site:
Press Releases
Data from Pomalidomide Study in Refractory Multiple Myeloma Patients Presented at ASCO
Jun 05, 2010 -- 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.
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.
About Pomalidomide
Pomalidomide is an IMiDs(R) 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 Celgene
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.
Press Releases
Data from Pomalidomide Study in Refractory Multiple Myeloma Patients Presented at ASCO
Jun 05, 2010 -- 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.
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.
About Pomalidomide
Pomalidomide is an IMiDs(R) 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 Celgene
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.
posted by gwg at 5:38 PM
2 Comments:
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