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Abstract Details
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Activity Number:
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473
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Type:
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Contributed
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Date/Time:
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Wednesday, August 1, 2012 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #303985 |
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Title:
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Semi-Mechanistic Modeling of the Dependence Structure Between Progression-Free Survival and Overall Survival
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Author(s):
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Dominik Heinzmann*+
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Companies:
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Roche
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Address:
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Malzgasse 30, Basel 4070, , Switzerland
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Keywords:
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Probability of technical success ;
Melanoma ;
PFS ;
OS
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Abstract:
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For pharmaceutical companies, it is essential to estimate probability of technical success (PTS) conditional on the different clinical phases to decide about further development strategies. In this talk, the focus is on PTS of a Phase III trial with overall survival (OS) as endpoint conditional on a Phase II trial with progression-free survival (PFS) as endpoint. A statistical model is discussed for describing the dependence structure between PFS and OS. This functional relationship allows deviation of a correlation factor and hence assessing PFS as a predictive marker for OS. A simulation study is presented to illustrate operational characteristics of the approach. The utility of the model is shown based on a case study with the molecule ZelborafT (vemurafenib), a drug to treat patients with late-stage (metastatic) or unresectable (cannot be removed by surgery) melanoma, the most dangerous type of skin cancer.
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The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.
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