Results positive for Afinitor (Novartis) in BOLERO-3 study in HER2 positive Breast Cancer

Results of a pivotal Phase III trial in women with HER2 positive (HER2+) advanced Breast Cancer showed that Afinitor (everolimus) tablets, from Novartis, in combination with Herceptin (trastuzumab) and vinorelbine significantly extended progression-free survival (PFS) after prior therapy when compared to treatment with placebo plus trastuzumab and vinorelbine, meeting the study's primary endpoint.

Efficacy and safety data from the BOLERO-3 trial were assessed as part of a prospectively planned analysis. These results will be presented on June 2 at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois, as well as at future medical congresses, and shared with regulatory authorities worldwide.

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 (HR+/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. HR+/HER2 negative advanced breast cancer is the most common form of the disease[5]. Approximately 70% of all invasive breast cancers are positive for HR expression at the time of diagnosis.