Genentech, Inc. has announced that Avastin® (bevacizumab), in combination with docetaxel chemotherapy, significantly increased the time women with metastatic breast cancer receiving first-line therapy lived without their disease advancing, as defined by the primary endpoint of progression-free survival (PFS).
In this Roche-sponsored, placebo-controlled Phase III trial (AVADO), two dose levels of Avastin in combination with docetaxel chemotherapy showed a statistically significant improvement in PFS compared to docetaxel chemotherapy alone, according to an investigator-assessed analysis. No new safety signals for Avastin were observed in the study.
Genentech is required to submit to the U.S. Food and Drug Administration (FDA) by mid-2009 the results of AVADO and RIBBON I, a third Phase III study in first-line metastatic breast cancer. Results for the RIBBON I study are expected later this year.