Genentech and Roche today announced that a randomized Phase III study of Avastin (bevacizumab) plus the FOLFOX4 chemotherapy regimen (oxaliplatin/5-FU/leucovorin), compared to FOLFOX4 alone, in second-line metastatic colorectal cancer patients achieved its primary endpoint of improving overall survival.
Results from an interim analysis demonstrated that patients receiving Avastin plus FOLFOX4 had a 26 percent reduction in the risk of death, a hazard ratio of 0.74, compared to patients who received FOLFOX4 alone. Median survival for patients receiving Avastin plus FOLFOX4 was 12.5 months, compared to 10.7 months for those receiving FOLFOX4 alone, a 17 percent improvement. A preliminary assessment of the safety profile suggested that Avastin could be combined safely with FOLFOX4 and adverse events observed in this study were consistent with other clinical trials in which Avastin was combined with chemotherapy.
The trial was sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health, and conducted by a network of researchers led by the Eastern Cooperative Oncology Group (ECOG). According to ECOG, preliminary study results will be presented during the ASCO Gastrointestinal Cancers Symposium, January 27-29, 2005 in Hollywood, Fla.
"Avastin is the first and only targeted therapy to demonstrate improvements in survival in both first- and second-line metastatic colorectal cancer," said Hal Barron, M.D., Genentech senior vice president, development and chief medical officer." "This is the first Phase III study to evaluate Avastin in combination with an oxaliplatin-based chemotherapy regimen in patients with metastatic colorectal cancer. This study provides additional evidence that adding Avastin to chemotherapy results in a significant survival benefit for patients with either untreated or relapsed metastatic colorectal cancer. We plan to share these Phase III results with the FDA to discuss the filing of a supplemental Biologics License Application for this combination in this setting of metastatic colorectal cancer."