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Avastin, Chemotherapy Shown to Improve Progression-Free Survival

April 18, 2005

Genentech and Roche have announced that an interim analysis of a Phase III study of Avastin plus paclitaxel chemotherapy in first-line metastatic breast cancer met its primary efficacy endpoint of showing an improvement in progression-free survival, compared to chemotherapy alone.

The trial was sponsored by the NIH's National Cancer Institute (NCI) under a cooperative research and development agreement between NCI and Genentech, and was conducted by a network of researchers led by the Eastern Cooperative Oncology Group.

This Phase III study was a randomized, controlled, multicenter trial that enrolled 722 women with previously untreated metastatic breast cancer. The patients enrolled in this trial were randomized to receive treatment with paclitaxel with or without Avastin (bevacizumab). Patients with HER2-positive metastatic breast cancer were not enrolled in the study unless they had received prior treatment with Herceptin (trastuzumab) or were unable to receive treatment with Herceptin. Patients who had received adjuvant paclitaxel within the previous 12 months and patients with a prior history of blood clots or who were receiving blood thinners were also excluded from the study.

Adverse events in this study appeared to be similar to those observed in previous clinical trials with Avastin in combination with chemotherapy in metastatic breast cancer. Adverse events that occurred more often in the Avastin arm included neuropathy, hypertension and proteinuria. Serious bleeding and blood clots were rare in this study. Additional adverse events were similar between the two treatment arms.