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Neratinib extended DFS in adjuvant treatment of breast cancer

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Puma Biotechnology Inc. recently announced that its investigational drug for the extended adjuvant treatment of breast cancer met its primary endpoint in a phase 3 ExteNET trial.

The ExteNET trial is a double-blind, placebo-controlled trial of neratinib (PB272, Puma Biotechnology) vs. placebo after adjuvant treatment with trastuzumab (Herceptin, Genentech) among 2,821 women with early-stage HER-2–positive breast cancer.

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 death for a period of two years after randomization in the trial.

The primary endpoint of the trial was disease free survival. The results of the trial demonstrated that treatment with neratinib resulted in a 33% improvement in disease free survival vs. placebo (HR=0.67, P=.0046).

The secondary endpoint of the trial was disease free survival including ductal carcinoma in situ. The results of the trial demonstrated that treatment with neratinib resulted in a 37% improvement in DFS including ductal carcinoma in situ vs. placebo (HR=0.63, P=.0009).

“We are very pleased with the results of the ExteNET trial with neratinib. This represents the first trial with a HER-2 targeted agent that has shown a statistically significant benefit in the extended adjuvant setting, which we believe provides a meaningful point of differentiation for neratinib in the treatment of HER-2–positive breast cancer,” Alan H. Auerbach, chief executive officer and president of Puma Biotechnology, said in a press release.

“While the use of trastuzumab in the adjuvant setting has led to a reduction in disease recurrence in patients with early stage HER-2–positive breast cancer, there remains an unmet clinical need for further improvement in outcome in order to attempt to further reduce this risk of recurrence. The results of the ExteNET study demonstrate that we may be able to provide this type of improvement with neratinib to further help the patients with this disease.”

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.