Bayer and Onyx's Nexavar Improves Overall Survival in Liver Cancer Study
Posted on: Monday, 19 May 2008, 12:00 CDT
Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals have announced that Nexavar tablets significantly improved overall survival by 47.3% in patients in the Asia-Pacific region with advanced hepatocellular carcinoma, or primary liver cancer compared to those receiving placebo.
The international, Phase III, randomized trial evaluated efficacy and safety of Nexavar versus placebo in 226 Asian patients with advanced hepatocellular carcinoma (HCC) who had not received prior systemic therapy. The study was designed to compare overall survival, time to progression, time to symptomatic progression, response as defined by Recist criteria and safety in patients receiving Nexavar versus placebo.
Median overall survival was 6.5 months in patients treated with Nexavar compared to 4.2 months for those taking placebo. The survival benefit was seen across multiple patient subsets analyzed, including age, extrahepatic spread and/or macroscopic vascular invasion. Median time to progression was 2.8 months in Nexavar-treated patients versus 1.4 months for those taking placebo. Median time to symptomatic progression was 3.5 months in patients treated with Nexavar versus 3.4 months for those taking placebo.
Disease control rate (complete response + partial response + stable disease >/= 12 weeks) was 35% in Nexavar-treated patients versus 16% for those taking placebo. Data from the study indicate that Nexavar was safe and well-tolerated in patients from the Asia-Pacific region. Nexavar also significantly improved time to progression in these patients by 74%.
Susan Kelley, vice president of therapeutic area oncology at Bayer HealthCare Pharmaceuticals, said: "These data provide further evidence that Nexavar is efficacious in liver cancer across multiple geographical regions and independent of disease characteristics and etiologies of underlying liver disease."
Source: Datamonitor
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