Genentech Progress With Breast Cancer Antibody

29 December 1997

Without releasing any details, Genentech has said it has encouragingpreliminary data from its Phase III trials program for Herceptin (trastuzumab), an anti-HER2 antibody for the treatment of advanced metastatic breast cancer.

Genentech has conducted two Phase III studies to test the antibody's activity in patients with HER2-expressing breast cancers, representing about 25% of of women with the disease. A 469-patient trial evaluated the efficacy and safety of adding Herceptin to initial treatment with two commonly-used chemotherapy regimens - Bristol-Myers Squibb's Taxol (paclitaxel) or anthracycline (generally doxorubicin) plus cyclophosphamide - compared to treatment with either of these regimens alone. All the women enrolled into the study had not received any prior treatment for their cancer.

The preliminary analysis of this study indicates that adding Herceptin to chemotherapy increased the clinical benefit by slowing the progression of the cancer and increasing tumor shrinkage. Further review of cancer progression and tumor-shrinkage data by an independent Response Evaluation Committee, and analysis of response duration, time to treatment failure, quality of life and survival, are in progress.

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