WAYNE, N.J. and EMERYVILLE, Calif., May 16 BayerHealthCare Pharmaceuticals, Inc. and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX)today announced that Nexavar(R) (sorafenib) tablets significantly improvedoverall survival by 47.3 percent (HR=0.68; p-value=0.014) in patients in theAsia-Pacific region with advanced hepatocellular carcinoma (HCC), or primaryliver cancer versus those receiving placebo. Nexavar also significantlyimproved time to progression in these patients by 74 percent (HR=0.57;P=0.001). These data were presented at the 44th annual meeting of the AmericanSociety of Clinical Oncology (ASCO) and further confirm Nexavar's efficacy inliver cancer.
The international, Phase 3, randomized trial evaluated efficacy and safetyof Nexavar versus placebo in 226 Asian patients with advanced HCC who had notreceived prior systemic therapy. The study was designed to compare overallsurvival, time to progression, time to symptomatic progression, response asdefined by RECIST criteria and safety in patients receiving Nexavar versusplacebo. Median overall survival was 6.5 months in patients treated withNexavar versus 4.2 months for those taking placebo. The survival benefit wasseen across multiple patient subsets analyzed, including age, extrahepaticspread and/or macroscopic vascular invasion.
"Liver cancer in the Asia-Pacific region continues to grow because of ahigh incidence of chronic hepatitis B viral infections, which now impactapproximately 275 million people in the region," said Ann-Lii Cheng, MD, PhD,Department of Internal Medicine and Department of Oncology, National TaiwanUniversity Hospital, Taipei, Taiwan and principal investigator of the trial."Nexavar demonstrated a clear survival benefit in Asia-Pacific patients andhad comparable results to last year's SHARP trial, despite these patients inthe Asia-Pacific trial having poorer health status and more metastases."
Data from the study indicate that Nexavar was safe and well-tolerated inpatients from the Asia-Pacific region. Adverse events were low to moderate inseverity and treatment was well tolerated. The most common serious adverseevents 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 livercancer across multiple geographical regions and independent of diseasecharacteristics and etiologies of underlying liver disease," said SusanKelley, MD, Vice President, Therapeutic Area Oncology, Bayer HealthCarePharmaceuticals. "Nexavar has quickly become the systemic standard of care forliver cancer, and is the only systemic therapy that has been shown to improveoverall survival in Asian patients with liver cancer."
Hepatocellular carcinoma is the most common form of liver cancer and isresponsible for about 90 percent of the primary malignant liver tumors inadults. Liver cancer is the sixth most common cancer in the world and thethird leading cause of cancer-related deaths globally. More than 600,000 casesof liver cancer are diagnosed worldwide each year (more than 400,000 in China,South Korea, Japan and Taiwan, 54,000 in the European Union, and 15,000 in theUnited States) and the incidence is increasing. In 2002, approximately 600,000people died of liver cancer including approximately 370,000 in China, SouthKorea and Japan, 57,000 in the European Union, and 13,000 in the UnitedStates.(1,2)
In addition, chronic hepatitis B (HBV) and C (HCV) viral infections arethe leading causes of primary liver cancer worldwide. In the Asia-Pacificregion, more than eight percent of the general population is infected with HBVand between two and four percent is infected with HCV.(3,4)
Nexavar's Differentiated Mechanism
Nexavar targets both the tumor cell and tumor vasculature. In preclinicalstudies, Nexavar has been shown to target members of two classes of