Abstract Details
Activity Number:
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282
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Type:
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Topic Contributed
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Date/Time:
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Tuesday, August 5, 2014 : 8:30 AM to 10:20 AM
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Sponsor:
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Biometrics Section
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Abstract #311798
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View Presentation
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Title:
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Case Study on Interpretation of Progression-Free Survival and Overall Survival in a Trial with Treatment Crossover: Tivozanib in Renal Cancer
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Author(s):
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Andrew Strahs*+
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Companies:
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Alnylam Pharmaceuticals
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Keywords:
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progression-free survival ;
overall survival ;
cancer ;
RPSFT ;
IPCW ;
survival analysis
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Abstract:
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We discuss the experience of tivozanib in renal cancer as a case study on the interpretation of progression free survival and overall survival. Tivozanib is a tyrosine kinase inhibitor of VEGF. The TIVO-1 trial compared tivozanib against an active control, sorafenib. TIVO-1 enrolled the majority of its 517 patients in Eastern Europe. The primary endpoint was progression-free survival (PFS); overall survival (OS) was a secondary endpoint. Patients whose cancer progressed on sorafenib were offered the opportunity to cross over to receive tivozanib; this option was widely utilized. Ultimately, PFS favored tivozanib (HR=0.80, p=0.042) but OS trended longer in the control arm (HR=1.25, p=0.10). These results were discussed at the US FDA's Oncology Drugs Advisory Committee on May 2, 2013.
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Authors who are presenting talks have a * after their name.
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