Strong mid-stage data on Nexavar

8 June 2008

Germany's Bayer HealthCare and US cancer specialist Onyx Pharmaceuticals presented encouraging data from Phase II trials of Nexavar (sorafenib) tablets in multiple tumor types including lung, thyroid, gastric and ovarian cancers at the 44th annual meeting of the American Society of Clinical Oncology, held in Chicago.

Preliminary findings from a randomized discontinuation Phase II study showed that treatment with Nexavar yielded encouraging results in heavily pre-treated patients with non-small cell lung cancer. Randomized patients who remained on Nexavar experienced a longer period of disease control and stabilization than those who discontinued the drug after the initial run-in phase of treatment. The primary endpoint of the study - difference in percentage of patients without disease progression after two months of treatment - was met. The most common drug-related adverse events included fatigue, hand/foot syndrome and skin rash.

Findings from a single-arm Phase II thyroid cancer study were also presented at the ASCO meeting. They showed Nexavar resulted in meaningful anti-tumor activity in the majority of patients with encouraging overall clinical benefit (both disease stabilization and partial responses) in advanced-stage patients.

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