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.
“We are disappointed in these results and will be evaluating the data to understand potential reasons why Avastin did not add a clinical benefit in this trial,” said Dr Hal Barron, chief medical officer of Genentech.
“Chemotherapy has had a limited impact in advancing outcomes for patients with pancreatic cancer, and treatments that may improve survival are desperately needed. We will continue to explore novel biologic and targeted therapy approaches that may lead to improved clinical outcomes for patients with pancreatic cancer,” continued Dr Barron.
Genentech is pursuing a broad development program for Avastin that currently includes 130 clinical trials across 25 different types of cancer. As part of this program, a randomized phase III study evaluating the addition of Avastin to a standard regimen of gemcitabine and Tarceva (erlotinib) in patients with pancreatic cancer is currently being conducted by Genentech's European partner, Roche.
Avastin, in combination with intravenous 5-FU-based chemotherapy, was approved by the FDA in February 2004 for first-line treatment of patients with metastatic colorectal cancer, and received approval in June 2006 for second-line treatment of colorectal cancer.
The company recently submitted supplemental biologics license applications to the FDA for Avastin in advanced non-small cell lung cancer, and for locally recurrent or metastatic breast cancer.