US Phase III study of Avastin in advanced pancreatic cancer does not meet primary endpoint

Roche announced that a US 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 decision to stop the trial was taken following a 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. The existing filings and approvals in colorectal, lung and breast cancer are not affected.

Pancreatic cancer is recognized as one of the most aggressive and most difficult-to-treat forms of cancer.

"Pancreatic cancer has a very high mortality and a short life expectancy and treatments that may improve survival are desperately needed. We will be further evaluating the data to understand potential reasons why this combination therapy did not lead to a clinical benefit in this trial", said Eduard Holdener, Head of Global Development at Roche. "In addition, we will continue with the large Avastin development programme and investigate the medicine in a broad range of cancers including another study in pancreatic cancer where Avastin is added to a standard regimen and Tarceva. It is important to note that Avastin is the first and only anti-angiogenic therapy with demonstrated significant survival benefits in the three most common cancer types: colorectal, lung and breast cancer."

The US phase III trial was sponsored by the NCI (National Cancer Institute) and NCI collaborators and investigators working on other Avastin pancreatic cancer trials will be notified of this development.

Roche and Genentech are pursuing a comprehensive clinical programme investigating the use of Avastin in 25 cancer types (including colorectal, breast, lung, pancreatic cancer, ovarian cancer, renal cell carcinoma, prostate cancer and others) across different settings. The trial programme also involves less prevalent and other difficult-to-treat cancers. The total development project is expected to include over 40,000 patients worldwide.

In Europe, Avastin was approved in early 2005 and in the US in 2004 for first-line treatment of patients with advanced colorectal cancer. Avastin was filed in April this year in the US for the most common form of lung cancer. The first filing for Avastin in Japan has been submitted in April 2006 for the treatment of advanced colorectal cancer. Most recently on May 26, 2006 Avastin was filed in the US for the treatment of women with advanced breast cancer.