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According to Genentech, the study showed the addition of one year of Avastin to chemotherapy did not result in a statistically significant improvement in overall disease-free survival (DFS), the primary endpoint, compared to chemotherapy alone after surgery.
Patients who received Avastin plus chemotherapy had a lower risk of the cancer returning during the year of treatment, however, the improvement diminished over the course of the study. No new safety signals for Avastin were observed.
Overall in the study, there was a 12% improvement in DFS that was not statistically significant (hazard ratio=0.89, p=0.15; risk reduction of 11%). In the first year of the study, while patients received Avastin in addition to a standard six months of adjuvant chemotherapy, DFS improved by 67% compared to chemotherapy alone (hazard ratio=0.60; risk reduction of 40%). However, this early improvement in DFS began to diminish after the first year, and overall DFS was not improved, the company said.
The C-08 study was conducted by the The National Surgical Adjuvant Breast and Bowel Project and sponsored by the National Cancer Institute (NCI) under a cooperative R&D agreement between Genentech and NCI. The C-08 study was a randomized multi-center Phase III study designed to evaluate the effect of Folfox chemotherapy with or without Avastin on DFS in patients with surgically-resected stage II or III adenocarcinoma of the colon.
Hal Barron, chief medical officer of Genentech, said: "We believe the C-08 results support the theory that Avastin may be an important medicine to help prevent early-stage colon cancer from returning and spreading to other parts of the body. The results are encouraging and reaffirm our commitment to fully evaluate the role of blocking the vascular endothelial growth factor protein in early-stage cancer with ongoing and future studies of Avastin."
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