Date: 2013-05-17
Type of information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago
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Company: Novartis (Switzerland)
Product: Afinitor® (everolimus)
Action
mechanism: Everolimus targets the PI3K/AKT/mTOR pathway, which is hyperactivated in many types of cancer. mTOR is a protein that acts as an important regulator of cell division, blood vessel growth and cell metabolism. Data confirm that blocking mTOR is a proven approach to maximize the benefit of existing advanced breast cancer treatments.
Disease: HER2 positive advanced breast cancer
Therapeutic area: Cancer - Oncology
Country:
Trial
details: 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. Participants were randomized 1:1 to receive either everolimus 5 mg/day orally or placebo, plus weekly vinorelbine 25 mg/m2 IV and weekly trastuzumab 2 mg/kg IV following loading dose of 4 mg/kg.
The primary endpoint of the trial is PFS. 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. (NCT01007942)
Latest
news: * On May 17, 2013, Novartis has announced that results of a pivotal Phase III trial in women with HER2 positive (HER2+) advanced breast cancer showed that Afinitor® (everolimus) tablets in combination with trastuzumab (Herceptin® 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 (Breast cancer trials of OraL EveROlimus-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. Approximately 70% of all invasive breast cancers are positive for HR expression at the time of diagnosis.
