Novartis AG (NVS) said Friday that results of a pivotal Phase III trial in women with HER2 positive advanced breast cancer showed that Afinitor, or everolimus, tablets in combination with trastuzumab nd vinorelbine significantly extended progression-free survival after prior therapy when compared to treatment with placebo plus trastuzumab and vinorelbine, meeting the study's primary endpoint.
The trial, BOLERO-3, is a Phase III, randomized, double-blind study of everolimus plus trastuzumab and vinorelbine conducted at 159 clinical trial sites globally. The trial included 569 women with HER2 positive locally advanced or metastatic breast cancer who were previously treated with a taxane and were resistant to trastuzumab.
The primary endpoint of the trial is progression-free survival. Secondary endpoints include overall survival, objective response rate, time to deterioration of performance status, changes in quality-of-life scores over time, clinical benefit rate, duration of response, time to response, safety and pharmacokinetics.
Globally, an estimated 140,000 women are living with HER2 positive advanced breast cancer, Novartis said.
Everolimus is approved as Afinitor in more than 65 countries including the United States and the countries of the European Union to treat postmenopausal women with hormone receptor-positive, HER2 negative advanced breast cancer in combination with exemestane, after recurrence or progression following a non-steroidal aromatase inhibitor. The specific indications vary
by country.
Afinitor tablets is also approved in more than 95 countries, including the United States and throughout the European Union, in the oncology settings of advanced renal cell carcinoma following progression on or after vascular endothelial growth factor-targeted therapy, and in the United States and
European Union for locally advanced, metastatic or unresectable progressive neuroendocrine tumors of pancreatic origin.
For comments and feedback: editorial@rttnews.com