Tuesday, Feb 12, 2008
South San Francisco, Calif. -- February 12, 2008 --Genentech, Inc. (NYSE: DNA) announced today 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.
About AVADO (BO17708)
AVADO was an international, multicenter, randomized and placebo-controlled clinical trial that enrolled 736 patients with previously untreated, locally recurrent or metastatic HER2-negative breast cancer. Patients were randomized to one of two doses of Avastin (15 mg/kg or 7.5 mg/kg) or placebo given every three weeks in combination with docetaxel at 100 mg/m2 every three weeks for up to nine cycles. Patients discontinuing docetaxel for toxicity or after nine cycles were to continue Avastin or placebo until disease progression. The primary endpoint was PFS, defined as the time from randomization to the first event of progression or death. Secondary endpoints included overall survival, response rate, time to treatment failure, quality of life and safety.
Avastin is a therapeutic antibody designed to specifically inhibit vascular endothelial growth factor (VEGF), a protein that plays an important role in angiogenesis and the maintenance of existing blood vessels throughout the lifecycle of a tumor. By inhibiting VEGF, Avastin is designed to interfere with the blood supply to a tumor, which is thought to be critical to a tumor's ability to grow and spread in the body (metastasize). For more information on angiogenesis, visit http://www.gene.com. For full Prescribing Information and Boxed Warnings on Avastin, visit http://www.avastin.com.
The FDA first approved Avastin on February 26, 2004, as a first-line treatment for metastatic colorectal cancer in combination with intravenous 5-FU-based chemotherapy. Avastin is also indicated in combination with intravenous 5-FU-based chemotherapy for second-line treatment of patients with metastatic carcinoma of the colon or rectum. On October 11, 2006, the FDA approved Avastin in combination with carboplatin and paclitaxel for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer.
Avastin has a well-characterized safety profile in its approved indications. The most serious adverse events associated with Avastin across all trials were gastrointestinal perforation, wound healing complications, hemorrhage, non-GI fistula formation, arterial thromboembolic events, hypertensive crisis, reversible posterior leukoencephalopathy syndrome (RPLS), neutropenia and infection, nephrotic syndrome and congestive heart failure. The most common adverse events seen in patients receiving Avastin across all studies were asthenia, pain, abdominal pain, headache, hypertension, diarrhea, nausea, vomiting, anorexia, stomatitis, constipation, upper respiratory infection, epistaxis, dyspnea, exfoliative dermatitis and proteinuria.
Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. A considerable number of the currently approved biotechnology products originated from or are based on Genentech science. Genentech manufactures and commercializes multiple biotechnology products and licenses several additional products to other companies. The company has headquarters in South San Francisco, California, and is listed on the New York Stock Exchange under the symbol DNA. For additional information about the company, please visit http://www.gene.com.
This press release contains forward-looking statements regarding the potential of Avastin as a treatment option for metastatic breast cancer and its safety and efficacy in such setting. Such statements are predictions and involve risks and uncertainties such that actual results may differ materially. Actual results may be affected by a number of factors including, but not limited to, unexpected safety, efficacy or manufacturing issues, the need for additional data or clinical studies, FDA actions or delays, failure to obtain or maintain FDA approval, competition, pricing, reimbursement, the ability to supply product, product withdrawals and new product approvals and launches, and intellectual property or contract rights. Please also refer to the risk factors described in Genentech's periodic reports filed with the Securities and Exchange Commission. Genentech disclaims, and does not undertake, any obligation to update or revise any forward-looking statements in this press release.