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Puma Biotechnology Inc announces positive top line results from Phase III PB272 trial in Adjuvant Breast Cancer (ExteNET Trial)


Tuesday, 22 Jul 2014 04:20pm EDT 

Puma Biotechnology Inc:Says top line results from Phase III clinical trial of Puma's investigational drug PB272 (neratinib) for extended adjuvant treatment of breast cancer (ExteNET Trial).ExteNET trial is double-blind, placebo-controlled, Phase III trial of neratinib versus placebo after adjuvant treatment with trastuzumab (Herceptin) in women with early stage HER2-positive breast cancer.Primary endpoint of the trial was disease free survival (DFS).Results of the trial demonstrated that treatment with neratinib resulted in a 33 pct improvement in disease free survival versus placebo.Hazard ratio was determined to be 0.67 which was statistically significant with a p-value of 0.0046.Secondary endpoint of trial was disease free survival including ductal carcinoma in situ (DFS-DCIS).Results of the trial demonstrated that treatment with neratinib resulted in a 37 pct improvement in disease free survival including ductal carcinoma in situ versus placebo.Hazard ratio was determined to be 0.63 which was statistically significant with p-value of 0.0009.Based on these results from the ExteNET study, Puma plans to file for regulatory approval of neratinib in the extended adjuvant setting in the first half of 2015. 

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30 Mar 2015