A Phase III study of Genentech and Roche’s drug Avastin with paclitaxel chemotherapy in first- line metastatic breast cancer proved to be more effective than chemotherapy alone.
Results from an interim analysis of this study showed that patients receiving Avastin plus paclitaxel doubled the duration of surviving without cancer progression compared to paclitaxel alone.
According to a press release, median progression-free survival was 11 months for patients treated with Avastin plus chemotherapy, compared to six months for patients treated with chemotherapy alone. At this interim analysis, a 49% improvement in the secondary endpoint of overall survival was observed.
Survival data continue to mature. In patients with measurable disease, the overall response rate was 28% in the Avastin plus chemotherapy arm, a 100 percent increase over the 14% observed in the chemotherapy alone arm.
“This is the first successful study to show that the scientific approach of attacking a tumor’s blood supply by inhibiting angiogenesis can result in improved outcomes for women with first-line metastatic breast cancer, and the study is particularly important given the magnitude of the improvement seen in progression-free survival, the study’s primary endpoint,” said the study’s principal investigator, Kathy D. Miller, M.D.
Hypertension occurred in 13% of patients treated with Avastin plus chemotherapy but not in any who received just chemotherapy. Proteinuria occurred in 2% of patients in the Avastin plus chemotherapy arm compared to no patients in the chemotherapy alone arm.
One patient in the Avastin plus chemotherapy arm developed symptomatic congestive heart failure (CHF). Serious bleeding and blood clots were rare in this study.
“The results from this study are an important advance in the potential treatment of breast cancer,” said Hal Barron, M.D., Genentech’s senior vice president, development, and chief medical officer. Genentech is planning to file a supplemental Biologics License Application (sBLA) for Avastin plus chemotherapy in first-line metastatic breast cancer with the FDA.
Chris is a staff writer for webproworld. Visit webproworld for the latest ebusiness news.