Roche announced that a phase-III study of Avastin (bevacizumab) in combination with a range of chemotherapies met its primary endpoint of increasing the time women with previously treated advanced HER2 negative breast cancer lived without the disease getting worse (progression-free survival or PFS) compared to chemotherapy alone. In the Ribbon-2 study, investigators chose the type of chemotherapy used in combination with Avastin and the chemotherapies were assessed together in the primary endpoint analysis. No new Avastin safety signals were observed in the study. Data from the study will be submitted for presentation at a future medical meeting.
"This is good news for women with advanced breast cancer as nearly all women require additional therapy after their initial treatment," said William M Burns, CEO of Roche's Pharmaceuticals Division. "Ribbon-2 is the first phase-III study to show that Avastin may also offer benefits in the second-line setting, and we look forward to sharing the data with healthcare authorities around the world."
In March 2007, Avastin was approved in Europe for the first-line treatment of patients with advanced breast cancer, in combination with paclitaxel. The European licence was recently extended in July 2009 to allow combination with another commonly used taxane based chemotherapy called docetaxel. Avastin was also approved in combination with paclitaxel in the US in February 2008 under the Food and Drug Administration's (FDA) accelerated approval programme, which allows provisional approval of medicines for cancer or other life-threatening diseases.
Despite the treatment improvements that have already been made, breast cancer continues to be the leading cause of cancer death in women under age of 55. More than one million women are diagnosed with breast cancer each year, this leading to over 500,000 deaths from the disease worldwide.
Ribbon-2 is an international, multi-centre, randomised, double-blind, placebo-controlled clinical study that enrolled 684 patients with previously treated metastatic HER2-negative breast cancer.
Avastin is an antibody that specifically binds and blocks VEGF (vascular endothelial growth factor).