Positive results from the clinical trial evaluating neratinib for the extended adjuvant treatment of early stage HER2-positive breast cancer following trastuzumab-based therapy (ExteNET trial) were presented at the European Society of Medical Oncology (ESMO) 2017 Congress in Madrid, Spain.
About HER2-Positive Breast Cancer
Approximately 20% to 25% of breast cancers over-express the HER2 protein. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that Herceptin (trastuzumab) can reduce the risk of early stage HER2-positive breast cancer returning after surgery, up to 25% of patients treated with herceptin experience recurrence.
About Nerlynx™ (neratinib)
Nerlynx is a novel tyrosine kinase inhibitor that is targeted against several biochemical pathways implicated in the growth and spread of cancer. Specifically, Nerlynx is targeted against the HER1, HER2, and HER4 pathways and was approved by the U.S. Food and Drug Administration (FDA) in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy.
The ExteNET clinical trial directly evaluated Nerlynx versus placebo after surgery and adjuvant treatment with Herceptin in patients with early stage HER2-positive breast cancer. Overall 2,840 patients in 41 countries with early stage HER2-positive breast cancer who had undergone surgery and adjuvant treatment with Herceptin were treated additionally with either Nerlynx or placebo for a period of one year.
The trial demonstrated that after a median follow up of 5.2 years, treatment with Nerlynx resulted in a 27% reduction in the risk of invasive disease recurrence or death.
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