Monday, Sep 9, 2002
South San Francisco, Calif. -- September 9, 2002 --Genentech, Inc. (NYSE: DNA) today announced that a Phase III study of Avastin™ (bevacizumab, rhuMAb-VEGF) in relapsed metastatic breast cancer patients did not meet its primary efficacy endpoint of progression-free survival. Avastin is an investigational therapeutic antibody directed at vascular endothelial growth factor (VEGF). This study randomized 462 women with metastatic breast cancer who had previously received treatment with both anthracycline and taxane-based chemotherapy regimens to receive Avastin with Xeloda? (capecitabine) or Xeloda alone. One of the secondary endpoints, overall response rate, did achieve statistical significance, but this did not translate into benefit in progression-free survival or twelve-month survival.
The adverse event profile in this study was similar to the observed events in Phase II studies and included venous thrombosis, hypertension and asymptomatic proteinuria. There was no increase in serious bleeding in the Avastin arm of the study.
"Given the prior Phase II results with Avastin in breast cancer, we are disappointed in the Phase III efficacy results. In view of the broad nature of our Avastin clinical program, we are encouraged by the overall safety profile observed in this study," said Susan D. Hellmann, M.D., M.P.H., Genentech’s executive vice president, Development and Product Operations, and chief medical officer. "The results seen in our overall Phase II program lead us to continue to believe in VEGF as a potentially important target for cancer therapy. We look forward to data from our 900-patient randomized Phase III trial in colorectal cancer, the lead indication in our comprehensive clinical development program."
The randomized Phase II study in colorectal cancer, presented at the American Society of Clinical Oncology (ASCO) in 2000, demonstrated an increase in overall survival, time to disease progression and overall response rate in patients treated with Avastin in combination with chemotherapy as compared to those treated with chemotherapy alone.
Genentech has submitted the Avastin/Xeloda Phase III data set to the Symposium Program Committee of the San Antonio Breast Cancer Symposium, which will occur in December 2002.
Comprehensive Clinical Trial Program
Genentech is pursuing a broad late stage clinical development program with Avastin to evaluate its potential use in metastatic breast, colorectal, non-small cell lung and kidney cancer. Phase II trials in metastatic breast, colorectal, non-small cell lung and kidney cancers have been successfully completed.
Enrollment is complete in the Avastin 900-patient Phase III metastatic colorectal cancer study comparing Avastin plus CPT-11/5-FU/Leucovorin (Saltz regimen) versus the Saltz regimen alone. Enrollment is also complete in an additional metastatic colorectal cancer trial, in which approximately 200 patients who were not optimal candidates for CPT-11 treatment received Avastin plus 5-FU/Leucovorin or 5-FU/Leucovorin alone. Both colorectal studies have overall survival as their primary endpoint. Patient enrollment also continues in several Eastern Cooperative Oncology Group (ECOG) studies with Avastin, including a Phase II/III trial in metastatic non-small cell lung cancer, a Phase II/III first-line metastatic breast cancer trial, and a Phase III clinical trial in relapsed, metastatic colorectal cancer in which Avastin is being combined with oxaliplatin (Eloxatin™)/5-FU/Leucovorin.
Avastin is a humanized therapeutic antibody designed to bind to and inhibit VEGF, a protein that plays a critical role in tumor angiogenesis (the formation of new blood vessels to the tumor) and maintenance of established tumor blood vessels, thereby inhibiting further tumor growth. For information about Avastin clinical trials, please call 888-662-6728.
About Genentech Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. Fifteen of the currently approved biotechnology products originated from or are based on Genentech science. Genentech manufactures and commercializes ten biotechnology products directly in the United States. The company has headquarters in South San Francisco, California, and is traded on the New York Stock Exchange under the symbol DNA.
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The statements made in this press release regarding the time frame of data availability from the Phase III trial of Avastin in colorectal cancer are forward looking and actual results may differ materially. Among other things, the timing of the availability of the data could be affected by the length of time to achieve study endpoints, additional time requirements for data analysis or discussions with the FDA.