The phase III study, named E3200, compared Avastin (bevacizumab) plus the FOLFOX4 chemotherapy regimen (oxaliplatin/5-FU/leucovorin), to FOLFOX4 alone in second-line metastatic colorectal cancer patients. Its primary endpoint, met by the combination treatment, was an improvement in overall survival.
Results from a preliminary analysis of the E3200 study demonstrated that patients receiving Avastin plus FOLFOX4 had a 26% reduction in the risk of death, 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% improvement.
“Avastin is the only targeted therapy to demonstrate an improvement in survival in first-line metastatic colorectal cancer patients, who on average face a two-year life expectancy upon diagnosis,” said Dr Gwen Fyfe, Genentech’s vice president of clinical hematology/oncology.
“The results from this study add to the growing body of data showing that the addition of Avastin to 5-FU-based chemotherapy regimens can result in meaningful clinical benefit to patients with metastatic colorectal cancer, and we have initiated discussions with the FDA to determine a filing strategy for the use of Avastin plus FOLFOX in the second-line population,” she continued.
Avastin is currently approved as a first-line treatment for metastatic colorectal cancer in combination with intravenous 5-FU-based chemotherapy.