Nexavar sorafenib: Phase IIb data

A double-blind, U.S. Phase IIb trial in 160 patients with locally advanced or metastatic HER2-negative breast cancer who were previously treated with a bevacizumab-containing regimen showed that twice-daily 400 mg oral Nexavar plus gemcitabine or capecitabine met the primary endpoint of significantly improving median PFS vs. placebo plus gemcitabine or capecitabine (3.4 vs. 2.7 months, p=0.01). Nexavar plus chemotherapy also met the secondary endpoint of significantly improving median TTP vs. placebo plus chemotherapy (3.6 vs. 2.7 months, p=0.009). Additionally, Nexavar plus chemotherapy led to an overall response rate (ORR) of 19.8% vs. 12.7% for placebo plus chemotherapy (p=0.12). Data are being presented at the American Society of Clinical Oncology meeting in Chicago. ...