Genentech, Inc announced that a phase-III study (RIBBON 1) of Avastin (bevacizumab), in combination with taxane, anthracycline-based or capecitabine chemotherapies for first-line treatment of metastatic HER2-negative breast cancer, met its primary endpoint of increasing the time patients lived without their disease advancing, compared to the chemotherapies alone. The primary endpoint of progression-free survival (PFS) was assessed by the treating physicians in the study (investigator-assessed). The safety profile of Avastin was consistent with previous experience and no new safety signals were observed. The data, including additional analyses, will be submitted for presentation at a future medical meeting.

The phase-III trial (RIBBON 1) comprised two independently-powered study groups that evaluated Avastin with different types of chemotherapies in patients who had not previously received chemotherapy for their advanced HER2-negative breast cancer. In the first study group, patients received either Avastin or placebo in combination with taxane or anthracycline-based chemotherapies. In the second study group, patients received either Avastin or placebo in combination with capecitabine chemotherapy. The primary endpoint was met for both study groups.

"The findings of this study, together with the positive PFS results from the E2100 and AVADO phase-III trials, support Avastin's ability to delay cancer progression with commonly used chemotherapies in metastatic HER2-negative breast cancer," said Hal Barron, senior vice president, Development and chief medical officer. "We look forward to discussing these data with the FDA and are committed to securing full FDA approval of Avastin based on the totality of data in advanced breast cancer. We plan to submit the data from RIBBON 1 and AVADO to the FDA by mid-2009."


Avastin was approved for advanced breast cancer in February 2008 under the US Food and Drug Administration's (FDA) accelerated approval program, which allows provisional approval of medicines for cancer or other life-threatening diseases. Avastin, in combination with paclitaxel, is indicated for the treatment of patients who have not received chemotherapy for metastatic HER2-negative breast cancer. The effectiveness of Avastin in metastatic breast cancer is based on an improvement in PFS. Avastin is not indicated for patients with breast cancer that has progressed following anthracycline and taxane chemotherapy administered for metastatic disease. Currently, no data are available that demonstrate an improvement in disease-related symptoms or increased survival with Avastin in breast cancer.

A full review of data from the studies RIBBON 1 and AVADO is required for the accelerated approval to be converted into a full approval. As a part of the company's commitment to fully evaluate Avastin in breast cancer, Genentech also will submit to the FDA data from three additional randomized trials that are either ongoing or planned.

RIBBON 1 is an international, multicenter, randomized, double-blind, placebo-controlled clinical study that enrolled 1,237 patients with locally recurrent or metastatic HER2-negative breast cancer who had not received chemotherapy for their metastatic disease.

Avastin is a biologic antibody designed to specifically inhibit the vascular endothelial growth factor (VEGF) protein that plays an important role in the development and maintenance of blood vessels, a process known as angiogenesis.

Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines for patients with significant unmet medical needs.