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Puma biotechnology Data from Trial of Neratinib in HER2-Positive Breast Cancer Demonstrates Continued Benefit After 5 years.

M2 PHARMA-September 11, 2017-Puma biotechnology Data from Trial of Neratinib in HER2-Positive Breast Cancer Demonstrates Continued Benefit After 5 years

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- US-based cancer care-focused company Puma biotechnology, Inc. (NASDAQ: PBYI) is presenting positive results from the Phase III clinical trial of Puma's drug neratinib for the extended adjuvant treatment of early stage HER2-positive breast cancer following trastuzumab-based therapy (ExteNET trial) at the European Society of Medical Oncology 2017 Congress in Madrid, Spain, the company said.

Neratinib was approved by the US Food and Drug Administration in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy, and is marketed in the United States as Nerlynx (neratinib) tablets.

The ExteNET trial is a double-blind, placebo-controlled, Phase III trial of neratinib versus placebo after adjuvant treatment with trastuzumab (Herceptin) in patients with early stage HER2-positive breast cancer.

The ExteNET trial randomized 2,840 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 death for a period of five years after randomization in the trial.

The primary endpoint of the trial was invasive disease free survival. The results of the trial demonstrated that after a median follow up of 5.2 years, treatment with neratinib resulted in a 27% reduction of risk of invasive disease recurrence or death versus placebo (hazard ratio = 0.73, p = 0.008).

The 5-year iDFS rate for the neratinib arm was 90.2% and the 5-year iDFS rate for the placebo arm was 87.7%.

The secondary endpoint of the trial was invasive disease free survival including ductal carcinoma in situ (iDFS-DCIS). The results of the trial demonstrated that treatment with neratinib resulted in a 29% reduction of risk of disease recurrence including DCIS or death versus placebo (hazard ratio = 0.71, p = 0.004). The 5-year iDFS-DCIS rate for the neratinib arm was 89.7% and the 5-year iDFS-DCIS rate for the placebo arm was 86.8%.

The most common adverse reactions were diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail disorder, dry skin, abdominal distention, epistaxis, weight decreased and urinary tract infection.

Puma biotechnology is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care.

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Publication:M2 Pharma
Date:Sep 11, 2017
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