Genentech announces Phase III study of Avastin in women treated with chemotherapy for advanced breast cancer

Genentech, Inc., a wholly owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced results from a Phase III study (RIBBON 2) of Avastin^® (bevacizumab) in women who had previously been treated with initial (first-line) chemotherapy for advanced HER2-negative breast cancer and needed additional (second-line) treatment.

The study showed that women who received Avastin in combination with a commonly used chemotherapy had a 28 percent improvement in the likelihood of living without the disease getting worse (progression-free survival or PFS), compared with those who received chemotherapy alone (hazard>

“It’s important for women with advanced breast cancer whose disease has worsened after their first treatment to have as many treatment choices as possible,” said Dr. Adam Brufsky, M.D., Medical Director of the Women's Cancer Center, University of Pittsburgh Medical Center and principal investigator of the study. “This is the first Phase III study that showed an anti-angiogenic medicine combined with chemotherapy extended the time women with advanced HER2-negative disease, whose initial chemotherapy had stopped working, lived without the cancer worsening.”

The 28 percent improvement in PFS observed in RIBBON 2 can also be referred to as a 22 percent reduction in the risk of cancer progression or death (hazard>

Results of the RIBBON 2 study were featured today during a press briefing at the 32nd Annual San Antonio Breast Cancer Symposium. Full results will be presented this afternoon (Abstract #42 – Friday, December 11, 2009, 3:00 p.m. – 3:15 p.m. CST, Exhibit Hall D).

“RIBBON 2 is the fourth Phase III trial in this disease that showed the combination of Avastin and standard chemotherapies delayed the spread or growth of tumors more than the chemotherapies alone,” said Hal Barron, M.D., executive vice president, Global Development and chief medical officer, Genentech. “We look forward to discussing these data with the FDA.”

Avastin is currently approved in combination with paclitaxel chemotherapy as a first-line treatment for women who have not received chemotherapy for advanced HER2-negative breast cancer. This approval was based on results of the Phase III E2100 study and granted under the U.S. Food and Drug Administration’s (FDA) accelerated approval program, which allows provisional approval of medicines for cancer or other life-threatening diseases. 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.