Roche announced the results of the first phase-III trial evaluating the use of Avastin (bevacizumab) plus chemotherapy (FOLFOX) for the treatment of colon cancer immediately following surgery (adjuvant therapy) compared to chemotherapy alone. The study, known as NSABP C-08, did not meet its primary endpoint of lowering the risk of the cancer returning (disease-free survival). This is the first trial of Avastin in early-stage cancer and results do not affect approved indications in advanced (metastatic) disease.
Safety findings were consistent with those presented from this study at the 2008 American Society of Clinical Oncology (ASCO) annual meeting (Allegra et al.)
"While we are disappointed the C-08 study did not meet its primary endpoint, our initial review of the data leads us to continue to believe Avastin may be active in patients with early-stage colon cancer and look forward to NSABP's presentation at ASCO," said Hal Barron, senior vice president, Development and chief medical officer, Genentech. "We remain fully committed to the ongoing Avastin adjuvant programmes in early-stage colon, breast and lung cancers."
"In order to provide patients with the full potential benefit of Avastin in early-stage cancer, we believe the findings of the C-08 trial should be considered for the ongoing adjuvant trial programmes," said William M Burns, CEO of Roche's Pharmaceuticals Division. "The current studies and indications in advanced disease are not affected."
Data from the trial have been submitted for presentation at the upcoming ASCO annual meeting, May 29 - June 2, 2009.
Avastin in combination with IV 5-FU-based chemotherapy was proven to extend overall survival by 52 percent compared to chemotherapy alone in people with advanced colorectal cancer. 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.