The clinical trial was sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health, and conducted by a network of researchers led by the Eastern Cooperative Oncology Group. Genentech, Inc., South San Francisco, Calif., which manufactures bevacizumab, provided bevacizumab for the trial under the Cooperative Research and Development Agreement (CRADA) with NCI for the clinical development of bevacizumab.
The Data Monitoring Committee overseeing the trial (known as E4599)* recommended that the results of a recent interim analysis be made public because the study had met its primary endpoint of improving overall survival. Researchers found that patients in the study who received bevacizumab in combination with standard chemotherapy (a treatment regimen of paclitaxel and carboplatin) had a median overall survival of 12.5 months compared to patients treated with the standard chemotherapy alone, who had a median survival of 10.2 months. This difference is statistically significant. Detailed results from this trial will be presented at the American Society of Clinical Oncology Annual Meeting (ASCO) to be held in Orlando, Fla., on May 13-17, 2005.
"The exciting results of this randomized study reveal, for the first time, an improvement in survival with the addition of a targeted agent to standard chemotherapy in this patient population," said Study Chair Alan B. Sandler, M.D., of the Vanderbilt University Medical Center in Nashville, Tenn.
"This study demonstrates that mechanistic-based interventions such as angiogenesis inhibitors are making important contribution
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Contact: NCI Press Officers
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NIH/National Cancer Institute
14-Mar-2005