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July 22, 2014
16:27 EDTPBYIPuma Biotechnology reports positive top line results from Phase III PB272 trial
Puma Biotechnology announced top line results from the Phase III clinical trial of Puma's investigational drug PB272 for the extended adjuvant treatment of breast cancer, or ExteNET Trial. The ExteNET trial is a double-blind, placebo-controlled, Phase III trial of neratinib versus placebo after adjuvant treatment with trastuzumab in women with early stage HER2-positive breast cancer. More specifically, the ExteNET trial enrolled 2,821 patients in 41 countries with early-stage HER2-positive breast cancer who had undergone surgery and adjuvant treatment with trastuzumab. After completion of adjuvant treatment with trastuzumab, patients were randomized to receive extended adjuvant treatment with either neratinib or placebo for a period of one year. Patients were then followed for recurrent disease, ductal carcinoma in situ, or DCIS, or death for a period of two years after randomization in the trial. The primary endpoint of the trial was disease free survival, or DFS. The results of the trial demonstrated that treatment with neratinib resulted in a 33% improvement in disease free survival versus placebo. The hazard ratio was determined to be 0.67 which was statistically significant with a p-value of 0.0046. The secondary endpoint of the trial was disease free survival including ductal carcinoma in situ, or DFS-DCIS. The results of the trial demonstrated that treatment with neratinib resulted in a 37% improvement in disease free survival including ductal carcinoma in situ versus placebo. The hazard ratio was determined to be 0.63 which was statistically significant with a 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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October 21, 2014
07:15 EDTPBYIFDA to hold workshop on breast cancer drug development
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October 16, 2014
09:21 EDTPBYIPuma Biotechnology participates in a conference call hosted by UBS
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