Nexavar Significantly Extends Overall Survival in Liver Cancer by 47 percent
Trial Results Confirm Efficacy for Population Most Affected by the Disease
Berlin, May 2008 – Bayer HealthCare and Onyx Pharmaceuticals, Inc. today announced that Nexavar® (sorafenib) tablets significantly improved overall survival by 47.3 percent (HR=0.68; p-value=0.014) in patients in the Asia-Pacific region with advanced hepatocellular carcinoma (HCC), or primary liver cancer, versus those receiving placebo. Nexavar also significantly improved time to progression in these patients by 74 percent (HR=0.57; P=0.001). These data will be presented at the 44th annual meeting of the American Society of Clinical Oncology (ASCO) and further confirm Nexavar’s efficacy in liver cancer.
The international, Phase III, randomized trial evaluated the efficacy and safety of Nexavar versus placebo in 226 patients from the Asia-Pacific region with advanced 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 versus 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.
“Liver cancer in the Asia-Pacific region continues to grow because of a high incidence of chronic hepatitis B infections, which now impacts approximately 275 million people in the region,” said Ann-Lii Cheng, MD, Ph. D., Department of Internal Medicine and Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan and principal investigator of the trial. “Nexavar demonstrated a clear survival benefit in Asia-Pacific patients and had comparable results to last year’s international SHARP trial, despite these patients in the Asia-Pacific trial having poorer health status and more metastases.”
Additional results from the trial showed that 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. The disease control rate (complete response + partial response + stable disease ≥ 12 weeks) was 35 percent in Nexavar-treated patients versus 16 percent for those taking placebo.
Data from the study indicate that Nexavar was safe and well-tolerated in patients from the Asia-Pacific region. Adverse events were low to moderate in severity and treatment was well tolerated. The most common serious adverse events observed in the study were hand-foot-skin reaction, diarrhea, alopecia, fatigue, and rash/desquamation.
“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,” said Susan Kelley, MD, Vice President, Therapeutic Area Oncology, Bayer HealthCare Pharmaceuticals. “Nexavar has quickly become the systemic standard of care for liver cancer, and is the only systemic therapy that has been shown to improve overall survival in Asian patients with liver cancer.”
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