Roche has announced that a phase III study of Avastin (bevacizumab), in combination with a range of chemotherapies, met its primary endpoint. The study met the objective of increasing the time women with previously treated advanced HER2 negative breast cancer lived without the disease getting worse (progression-free survival or PFS), as 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, said the company.
William Burns, CEO of Pharmaceuticals division at Roche, said: “This is good news for women with advanced breast cancer as nearly all women require additional therapy after their initial treatment. 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.”
Earlier 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 – docetaxel. Avastin was also approved in combination with paclitaxel in the US in February 2008 under the FDA accelerated approval program, which allows provisional approval of medicines for cancer or other life-threatening diseases.