Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals have announced that their first cooperative group-sponsored randomized phase II trial in advanced metastatic breast cancer met its primary endpoint of progression-free survival.
Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals have announced that their first cooperative group-sponsored randomized phase II trial in advanced metastatic breast cancer met its primary endpoint of progression-free survival (PFS). The study evaluated Nexavar (sorafenib) tablets in combination with capecitabine in 229 women with locally advanced or metastatic HER-2 negative breast cancer. The median PFS was found to be extended in patients treated with Nexavar and capecitabine compared with patients receiving capecitabine and placebo. This finding reached statistical significance (P = .0006), and no new or unexpected toxicities were observed with this drug combination. A complete data analysis from this study is expected to be presented at an upcoming scientific meeting.
According to Jose Baselga, MD, chairman and professor of medicine at Vall d’Hebron Institute of Oncology in Barcelona, and the principal investigator of this study, “this outcome represents a positive signal of the potential benefit of this combination for patients with advanced breast cancer and is the first statistical demonstration of efficacy for a multi-tyrosine kinase inhibitor in this disease.”
Bayer and Onyx are currently testing Nexavar in three ongoing phase II breast cancer studies and are working on possible trial setups for the third and last phase of testing required for regulatory approval. According to Todd Yancey, MD, vice president of clinical development at Onyx, “based on [the] encouraging data, Onyx and Bayer are evaluating various strategies for Nexavar in breast cancer,” and the company “[hopes] to establish Nexavar as an important new treatment option for patients with this devastating disease.” Nexavar is already being used worldwide in patients with liver and kidney cancers, and Bayer aims to generate worldwide sales of more than $2.84 billion annually from the drug.