Genentech has announced that a Phase III trial of Avastin (bevacizumab) in combination with gemcitabine chemotherapy as first-line treatment for advanced pancreatic cancer did not meet its primary endpoint of overall survival.
The trial was stopped at the recommendation of an independent data monitoring board based on an interim analysis indicating that it is very unlikely that significant differences in overall survival will be shown between treatment arms as the data mature. The study was not stopped due to safety events and no new safety concerns related to Avastin were observed in this trial.
This randomized, controlled study of 602 patients was sponsored by the National Cancer Institute and conducted by a network of researchers led by the Cancer and Leukemia Group B. The trial was initiated based on results from a single-arm Phase II study combining Avastin with gemcitabine in pancreatic cancer.