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News Breaks
December 10, 2013
08:36 EDTCELGCelgene reports on retrospective analyses of Phase III study of pomalidomide
Celgene announced that updated analyses from MM-003, the company’s phase III study of pomalidomide plus low-dose dexamethasone compared with high-dose dexamethasone in patients with refractory multiple myeloma who have failed therapy with both bortezomib and lenalidomide, administered either alone or in combination were presented at the American Society of Hematology Annual Meeting in New Orleans, La. It was previously reported that with a median follow-up of 10 months, pomalidomide plus low-dose dexamethasone significantly extended progression-free survival and overall survival compared with high-dose dexamethasone. The OS benefit was observed despite 50% of the patients in the high-dose dexamethasone arm receiving subsequent pomalidomide. The overall response rate for the pomalidomide plus low-dose dexamethasone arm and high-dose dexamethasone arm was 31% vs. 10%, respectively. The results were published in The Lancet Oncology in September. In a retrospective analysis, the increases in ORR and median PFS were maintained for pomalidomide plus low-dose dexamethasone compared with high-dose dexamethasone regardless of modified high-risk cytogenetics or standard-risk cytogenetics. Numerical increases in median OS were observed regardless of cytogenetics. Of note, 46% of patients receiving high-dose dexamethasone with high-risk and 64% of patients receiving high-dose dexamethasone with standard-risk cytogenetics received subsequent pomalidomide. In another retrospective analysis of MM-003 the effect of prior therapies on study outcomes was evaluated. The median number of prior therapies was 5. Most patients were refractory to both bortezomib and lenalidomide. In patients who received pomalidomide plus low-dose dexamethasone, the overall response rate for patients who had at least three prior therapies was 26% with 4% of those patients achieving at least a very good partial response. For patients who received pomalidomide plus low-dose dexamethasone and had less than three prior therapies, the overall response rate was 34% with 8% of patients achieving at least a very good partial response. The hazard ratio for risk of disease progression for pomalidomide plus low-dose dexamethasone compared with high-dose dexamethasone was HR=0.63 for patients with up to three prior therapies and HR=0.45 for patients with more than three prior therapies. The hazard ratio for risk of death for pomalidomide plus low-dose dexamethasone compared with high-dose dexamethasone was HR=0.56 for patients with at least three prior therapies and HR=0.76 for patients with up to three prior therapies.
News For CELG From The Last 14 Days
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April 22, 2014
07:40 EDTCELGCelgene weakness has created attractive entry point, says Stifel
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April 16, 2014
08:34 EDTCELGPiper Jaffray tech and biopharma analysts hold analyst/industry conference call
Technical Analyst Johnson, along with BioPharma Analysts, discuss the recent downturn in the biotech and specialty pharmaceuticals industries on an Analyst/Industry conference call to be held on April 17 at 10 am.
April 11, 2014
09:03 EDTCELGCelgene shares can unlock big value, says RBC Capital
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April 10, 2014
10:05 EDTCELGCelgene CEO Hugin says 'excited' about guidance for the year
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08:10 EDTCELGCelgene likely to prevail in patent case, says Stifel
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07:33 EDTCELGCelgene antibody could open door for new area of focus, says Wells Fargo
Wells Fargo believes that Celgene is developing an anti-CD47 antibody that could enable the company to enter the immune-oncology space and pivot into biologics. The firm views the stock as undervalued, and believes that Celgene has many viable opportunities that could enable the stock to rise over the long-term. The firm keeps an Outperform rating on the shares and identifies it as a top pick.
April 9, 2014
12:12 EDTCELGMarkman documents appear to favor Celgene, The Street says
Public documents for the pre-trial Markman hearing appear to favor Celgene over Natco, the generic drugmaker challenging some of Celgene's Revlimid patents, The Street's Adam Feuerstein reports. Shares of Celgene are up 5% to $145.33 in mid-day trading. Reference Link

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