Thursday, Mar 11, 2010
South San Francisco, Calif. -- March 11, 2010 --Genentech, Inc., a wholly owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today the topline results of a Phase III trial led by the U.S. Cancer and Leukemia Group B (CALGB) and sponsored by the National Cancer Institute (NCI) investigating the use of Avastin® (bevacizumab) in combination with docetaxel chemotherapy and prednisone in men with late stage prostate cancer (hormone-refractory / HRPC). The study, known as CALGB 90401, did not meet its primary objective of extending overall survival compared to chemotherapy and prednisone alone. A preliminary assessment of safety performed by CALGB has shown adverse events that have been previously observed in pivotal trials with Avastin. Data from the study will be submitted by CALGB for presentation at the American Society of Clinical Oncology (ASCO) annual meeting, June 4 to 8, 2010.
"Patients with hormone-refractory prostate cancer are in urgent need of new treatment options. It is unfortunate that the study did not meet its primary objective, however, we look forward to sharing the data with the medical community, including the secondary endpoints," said Hal Barron, M.D., head, Global Development and chief medical officer at Roche.
These findings do not impact Avastin's approved uses or its broad development program in other tumor types.
About Prostate Cancer
Among American men, prostate cancer is the most common form of cancer and the second leading cause of cancer death. According to the American Cancer Society, in 2009 an estimated 192,000 men were diagnosed with prostate cancer and approximately 27,000 died from the disease in the United States.
About CALGB 90401
CALGB 90401 is a multicenter, randomized, double-blinded, placebo-controlled Phase III study designed to evaluate Avastin plus docetaxel chemotherapy and prednisone, compared to docetaxel chemotherapy and prednisone alone in 1,050 men with hormone-refractory prostate cancer. The trial is sponsored by the NCI under a Cooperative Research and Development Agreement between the NCI and Genentech, and conducted by a network of researchers led by the CALGB.
The primary endpoint of the study is overall survival. Secondary endpoints of the study include progression-free survival, prostate-specific antigen response rate and safety.
Detailed safety assessments are ongoing. A preliminary assessment of safety performed by CALGB has identified severe adverse events that have been previously observed in pivotal trials with Avastin, including neutropenia and fatal infections.
Avastin is a solution for intravenous infusion and is a biologic antibody designed to specifically bind to a protein called vascular endothelial growth factor (VEGF). VEGF plays an important role throughout the lifecycle of the tumor to develop and maintain blood vessels, a process known as angiogenesis. Avastin interferes with the tumor blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. Avastin does not bind to receptors on normal or cancer cells. The tumor blood supply is thought to be critical to a tumor's ability to grow and spread in the body (metastasize). For more information about angiogenesis, visit http://www.gene.com.
Boxed WARNINGS and Additional Important Safety Information
People treated with Avastin may experience side effects. In clinical trials, some people treated with Avastin experienced serious and sometimes fatal side effects, including:
Gastrointestinal (GI) perforation: Treatment with Avastin can result in the development of a potentially serious side effect called GI perforation, which is the development of a hole in the stomach, small intestine or large intestine. In clinical trials, this side effect occurred in more people who received Avastin than in the comparison group (0.3 percent to 2.4 percent). In some cases, GI perforation resulted in fatality.
Surgery and wound healing problems: Treatment with Avastin can lead to slow or incomplete wound healing (for example, when a surgical incision has trouble healing or staying closed). In some cases, this event resulted in fatality. Surgery and wound healing problems occurred more often in people who received Avastin than in the comparison group. Avastin therapy should not be started for at least 28 days after surgery and until the surgical wound is fully healed. The length of time between stopping Avastin and having voluntary surgery without the risk of having surgery and wound healing problems following surgery has not been determined.
Severe bleeding: Treatment with Avastin can result in serious bleeding, including coughing up blood, bleeding in the stomach, vomiting of blood, bleeding in the brain, nosebleeds and vaginal bleeding. These events occurred up to five times more often in people who received Avastin. Across cancer types, 1.2 percent to 4.6 percent of people who received Avastin experienced severe to fatal bleeding. People who have recently coughed up blood (greater than or equal to a half teaspoon of red blood) or have serious bleeding should not receive Avastin.
In clinical trials for different cancer types, there were additional serious and sometimes fatal side effects that occurred in more people who received Avastin than in those in the comparison group. The formation of an abnormal passage from parts of the body to another part (non-GI fistula formation) was seen in 0.3 percent or less of people. Severe to life-threatening stroke or heart problems were seen in 2.4 percent of people. Too much protein in the urine, which led to kidney problems, was seen in less than 1 percent of people. Additional serious side effects that occurred in more people who received Avastin than those in the comparison group included severe to life-threatening high blood pressure, which was seen in 5 percent to 18 percent of people, and nervous system and vision disturbances (reversible posterior leukoencephalopathy syndrome), which was seen in less than 0.1 percent of people. Infusion reactions with the first dose of Avastin were uncommon and occurred in less than 3 percent of people and severe reactions occurred in 0.2 percent of people.
Common side effects that occurred in more than 10 percent of people who received Avastin for different cancer types, and at least twice the rate of the comparison group, were nosebleeds, headache, high blood pressure, inflammation of the nose, too much protein in the urine, taste change, dry skin, rectal bleeding, tear production disorder, back pain and inflammation of the skin (exfoliative dermatitis). Across all trials, treatment with Avastin was permanently stopped in 8.4 percent to 21 percent of people because of side effects.
Avastin may impair fertility. Patients who are pregnant or thinking of becoming pregnant should talk with their doctor about the potential risk of loss of the pregnancy or the potential risk of Avastin to the fetus during and following Avastin therapy, and the need to continue an effective birth control method for at least six months following the last dose of Avastin.
For full Prescribing Information and Boxed WARNINGS on Avastin please visit http://www.avastin.com.
Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a wholly owned member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.