Vidaza fails Phase 3 leukemia trial


Switzerland-based Celgene (CELG) subsidiary Celgene Interantional Sarl announces the results from a Phase 3 clinical trial evaluating the safety and efficacy of Vidaza (azacitidine for injection) compared to conventional care regimens (CCR) in elderly patients with newly-diagnosed acute myeloid leukemia (AML).

The primary endpoint was median overall survival (OS). The OS for the azacitidine group (n=241) was 10.4 months (8.0 - 12.7 months; 95% CI) compared to 6.5 months (5.0 - 8.6 months; 95% CI) in the CCR group (n=247). The results failed to achieve statistical significance.

One-year survival was 47% in the azacitidine cohort compared to 34% of patients receiving CCR.

The clinical trial was conducted to support a possible label expansion for Vidaza. It is currently indicated for treatment of patients with certain types of refractory anemia.

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Comments (12)
  • Patent News
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    not all can be winners
    14 Jun 2014, 01:28 PM Reply Like
  • Rich in NJ
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    It could present a buying opportunity.
    14 Jun 2014, 01:46 PM Reply Like
  • tarheelboy
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    Comments (348) | Send Message
     
    Not a real setback.
    14 Jun 2014, 01:55 PM Reply Like
  • Rick Skolrood
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    Vidaza has a small effect to the company's overall revenues
    14 Jun 2014, 03:00 PM Reply Like
  • blablah
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    Vidaza may still get used off label, esp if the AML is evolving from untreated MDS.
    14 Jun 2014, 05:15 PM Reply Like
  • Stanford Chemist
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    "The OS for the azacitidine group (n=241) was 10.4 months (8.0 - 12.7 months; 95% CI) compared to 6.5 months (5.0 - 8.6 months; 95% CI) in the CCR group (n=247). The results failed to achieve statistical significance."

     

    Dang, how is this not significant? Would seem that the majority of patients benefited...
    14 Jun 2014, 10:08 PM Reply Like
  • blablah
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    Probably low sample no. or would not have met pre-specified criterion.
    15 Jun 2014, 12:00 AM Reply Like
  • King Rat
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    That itself looked pretty good but perhaps the (high?) levels of side effects decreased the quality of life enough that it wasn't worth it. It seemed unclear to me. The drug still has other uses so it is not the end of the world. They just cannot patent it for this new purpose which would have given them a couple more decades of exclusive use.
    15 Jun 2014, 12:41 AM Reply Like
  • heavydutytruck1
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    Comments (20) | Send Message
     
    this negitive could drop the share price and be a buying opportunity
    14 Jun 2014, 11:11 PM Reply Like
  • drmike1000
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    Stanford Chemist...
    The results are not significant by log rank analysis of the kaplan meyer. Without seeing the kaplan meyer, one can appreciate this by noting that the confidence interval of the azacytidine group's OS overlaps with the confidence interval with the CCR group's OS--Close but no cigar. Unfortunate for Celgene and unfortunate for AML patients, because Azactidine is easier on patients than is conventional " 7 and 3", No one to blame except for Celgene's clinical team in not choosing better clinicians to run their trial, given the knowledge we have on how important OS is in being the final arbiter of efficacy when comparing drugs in similar classes which apriori would be expected to show only marginal differences in efficacy. Shame on you Celgene for not doing a better job.
    15 Jun 2014, 12:15 AM Reply Like
  • Stanford Chemist
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    Thank you for your expert opinion
    15 Jun 2014, 02:51 AM Reply Like
  • Patent News
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    Comments (1474) | Send Message
     
    kaplan meyer indeed!
    15 Jun 2014, 02:12 AM Reply Like
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