Novartis Presents Positive Results For Afinitor Trial At EBCC-9

Novartis reported positive results from the Phase III BOLERO-2 (breast cancer trials of ra velimus-) study of its drug Afinitor (everolimus) trial at the 9th European Breast Cancer Conference (EBCC-9) in Glasgow, Scotland.

The trial met its primary endpoints and showed Afinitor plus exemestane more than doubled progression-free survival in patients, setting the stage for more than 80 worldwide approvals including the most recent in Japan.

Gabriel Hortobagyi, MD, Professor of Breast Medical Oncology at the University of Texas MD Anderson Cancer Center, said “The BOLERO-2 trial shows that treatment with Afinitor in combination with exemestane works against multiple target pathways to slow the progression of hormone receptor-positive advanced breast cancer, even among patients who have progressed while on or within 12 months of completing adjuvant non-steroidal aromatase inhibitor therapy. This dual approach both extends the benefits of endocrine therapy while delaying the time until the patient needs chemotherapy, which can have an important impact on patients living with this disease.”

Everolimus, marketed under the brand name Afinitor, is the first and currently the only mTOR inhibitor approved for the treatment of HR+/HER2- advanced breast cancer. The drug targets the PI3K/AKT/mTOR pathway, which is usually hyperactivated in many cancer types. The protein mTOR acts as an important regulator of cell division, blood vessel growth and cell metabolism. Data showed that mTOR inhibition and dual hormone receptor continue to play a crucial role in treating HR+/HER2- advanced breast cancer following NSAI failure.

Alessandro Riva, MD, President of Novartis Oncology ad interim and Global Head of the Oncology Development and Medical Affairs, said “These data, along with experience from more than 18 months of real-world use, add to the growing body of evidence regarding the use of Afinitor plus exemestane in patients with hormone receptor-positive, HER2 negative advanced breast cancer after they progress on a non-steroidal aromatase inhibitor. We continue to research the role of Afinitor in advanced breast cancer and are committed to developing other novel therapies, such as those targeting the PI3K/AKT/mTOR and CDK 4/6 pathways.”

Afinitor is approved in over 80 countries for the treatment of HR+/HER2- advanced breast cancer in women. Indications vary by country.