Novartis Drug Afinitor® Met Primary Endpoint Of Phase III Study In Women

Novartis NVS announced today that an interim analysis of a pivotal Phase III study showed Afinitor (everolimus) tablets in combination with exemestane significantly extended progression-free survival, or time without tumor growth, when compared to placebo plus exemestane in women with advanced breast cancer. The trial was stopped early after interim results showed the primary endpoint of PFS was met. The study included postmenopausal women with ER+HER2- metastatic breast cancer whose disease has progressed, despite initial endocrine therapy. "Despite clinical progress in advanced breast cancer, most women are either initially resistant or develop resistance to endocrine therapy over time. As a result, there is a significant need for new treatment options," said Hervé Hoppenot, President, Novartis Oncology. "Based on these study results, this combination has the potential to extend the time until chemotherapy is needed for these patients."