Bayer announced that a Phase III trial of Stivarga (regorafenib) for the treatment of patients with unresectable hepatocellular carcinoma (HCC) met its primary endpoint of a significant improvement in overall survival. The company noted that it plans to use data from the trial in filings seeking approval of the drug in this indication in 2016.
The RESOURCE study included around 573 patients with HCC whose disease has progressed after treatment with Bayer's Nexavar (sorafenib). Subjects were randomised to receive either Stivarga plus best supportive care (BSC) or placebo plus BSC. As well as the trial's main goal of overall survival, secondary endpoints included time to progression, progression-free survival, objective tumour response rate and disease control rate.
According to Bayer, the safety and tolerability of Stivarga were generally consistent with the known profile of the therapy. The drugmaker added that detailed efficacy and safety analyses from the study are expected to be presented at an upcoming scientific meeting.
Last year, Bayer said that combined sales of five recently launched drugs, which include Stivarga, could generate peak annual sales of at least 7.5 billion euros ($8.6 billion). In the US, Stivarga is indicated for the treatment of certain patients with metastatic colorectal cancer, as well as for the treatment of certain patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumour.
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