Puma Biotechnology announced results from its Phase 3 ExteNET trial of neratinib (PB272) for the extended adjuvant treatment of breast cancer.
The ExteNET trial is a double-blind, placebo-controlled trial of neratinib vs. placebo after adjuvant treatment with Herceptin (trastuzumab; Genentech) in women (n=2821) 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 (DCIS), or death for a period of two years after randomization in the trial. The primary endpoint of the trial was disease free survival (DFS).
The results of the trial demonstrated that treatment with neratinib resulted in a 33% improvement in disease free survival vs. placebo. The hazard ratio was determined to be 0.67 which was statistically significant with a p-value of 0.0046.
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.
For more information visit Pumabiotechnology.com.