Genentech, Inc. (NYSE: DNA) announced that AVADO, a Roche-sponsored Phase III, placebo-controlled study evaluating Avastin? (bevacizumab) in combination with docetaxel chemotherapy met its primary endpoint of prolonging progression-free survival (PFS) in patients who had not received prior chemotherapy for their locally recurrent or metastatic HER2-negative breast cancer.
No new safety signals related to Avastin were observed. These data will be submitted for presentation at an upcoming medical meeting.
The AVADO study (BO17708) investigated the addition of Avastin administered either at 15 mg/kg or 7.5 mg/kg every three weeks to docetaxel chemotherapy. Both doses of Avastin in combination with chemotherapy showed statistically significant improvement in the time patients lived without their disease advancing compared to chemotherapy and placebo, based on investigator assessments.
“We are pleased that a second Phase III study in this population of breast cancer patients showed a significant improvement in PFS. The trial also demonstrated Avastin’s potential with a different chemotherapy in this disease,” said Hal Barron, M.D., senior vice president, Development and chief medical officer. “The AVADO data are not included in the supplemental Biologics License Application currently under review by the FDA. However, we have shared the AVADO data with the FDA to assist the agency in assessing the risk and benefit of Avastin in this patient population.”
The U.S. Food and Drug Administration (FDA) is reviewing Genentech’s supplemental Biologics License Application (sBLA) for the use of Avastin, in combination with paclitaxel chemotherapy, for the treatment of patients who have not received prior chemotherapy for their locally recurrent or metastatic HER2-negative breast cancer, and the FDA is expected to make a decision by February 23, 2008. In December 2007, an FDA advisory panel voted 5 to 4 that data from the E2100 study are not sufficient to establish a favorable risk/benefit analysis for the use of Avastin in this setting. Genentech believes that the results of the AVADO study provide confirmation of Avastin’s efficacy and safety in this patient population.
Breast cancer is the second most common form of cancer and the second leading cancer killer among American women. According to the American Cancer Society, an estimated 178,000 women were diagnosed with breast cancer and approximately 40,000 died from the disease in the U.S. in 2007. Genentech estimates that 75 percent of women with newly diagnosed metastatic breast cancer are HER2-negative.
Avastin was the first anti-angiogenesis therapy approved by the FDA and is currently indicated in combination with chemotherapy for the treatment of two of the three largest cancer killers in the U.S.: metastatic colorectal cancer and advanced, non-squamous, non-small cell lung cancer. Avastin is being studied worldwide in more than 300 clinical trials and in more than 20 different tumor types.
Source: Genentech, USA