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news.US-based biotechnology company Genentech has announced that a Phase III study of Avastin, in combination with taxane, anthracycline-based or capecitabine chemotherapies for first-line treatment of metastatic HER2-negative breast cancer, met its primary endpoint of increasing the time patients lived without their disease advancing, compared to the chemotherapies alone.
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The primary endpoint of progression free survival (PFS) was assessed by the treating physicians in the study (investigator-assessed). The safety profile of Avastin was consistent with previous experience and no new safety signals were observed, the company said.
The Phase III trial (Ribbon 1) comprised two independently powered study groups that evaluated Avastin with different types of chemotherapies in patients who had not previously received chemotherapy for their advanced HER2-negative breast cancer.
In the first study group, patients received either Avastin or placebo in combination with taxane or anthracycline-based chemotherapies. In the second study group, patients received either Avastin or placebo in combination with capecitabine chemotherapy. The primary endpoint was met for both study groups.
Hal Barron, senior vice president of development and chief medical officer of Genentech, said: “The findings of this study, together with the positive PFS results from the E2100 and Avado Phase III trials, support Avastin’s ability to delay cancer progression with commonly used chemotherapies in metastatic HER2-negative breast cancer.
“We look forward to discussing these data with the FDA and are committed to securing full FDA approval of Avastin based on the totality of data in advanced breast cancer. We plan to submit the data from Ribbon 1 and Avado to the FDA by mid-2009.”