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Published on 6/27/2006 in the Prospect News Biotech Daily.

Genentech stops phase 3 trial of Avastin after failure to meet endpoint of survival

By Lisa Kerner

Charlotte, N.C., June 27 - Genentech, Inc. said its randomized, controlled phase 3 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 company halted the trial based on recommendations from an independent monitoring board, which believes it is unlikely that significant differences in overall survival will be shown between treatment arms even as the data mature.

In the trial, known as CALGB and sponsored by the National Cancer Institute, 602 patients received treatment with gemcitabine plus Avastin or gemcitabine plus a placebo as a first-line therapy.

"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," chief medical officer Hal Barron said in a company news release.

The company is pursuing a broad development program for Avastin that includes 130 clinical trials across 25 different types of cancer.

Genentech is a biotechnology company based in South San Francisco, Calif.


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