WAYNE, N.J. and EMERYVILLE, Calif., Aug. 27 Bayer HealthCare Pharmaceuticals (NYSE: BAY) and Onyx Pharmaceuticals, Inc.(Nasdaq: ONXX) today announced that a planned review by an independent datamonitoring committee (DMC) found that Nexavar(R) (sorafenib) tabletssignificantly improved overall survival, progression free survival, and timeto progression in an Asia-Pacific regional Phase 3 trial of patients withadvanced hepatocellular carcinoma (HCC), the most common form of liver cancer.Based on the DMC's recommendation, the trial will be stopped to allow allpatients to receive treatment with Nexavar. Data from this study will besubmitted for presentation at an upcoming scientific meeting.
The Asia-Pacific liver cancer study was conducted at the request of Asianhealth authorities in order to provide supplemental information on Nexavar'sefficacy and safety in Asia-Pacific patient populations. Supplementalregulatory filings have been completed in several countries/regions includingEurope, China and the United States for Nexavar in the treatment of livercancer. These filings were based on positive data from the pivotal Phase 3SHARP study announced earlier this year. Additional regulatory submissions forNexavar in liver cancer are being finalized.
"Liver cancer incidence continues to rise in the Asia-Pacific region, dueto the high prevalence of hepatitis B virus infection," said Dr. Ann-LiiCheng, principal investigator and professor of medicine, National TaiwanUniversity Hospital. "These study results confirm that Nexavar's efficacy andtolerability in liver cancer extends across ethnic groups and geographies andsuggest that Nexavar could meet a tremendous unmet need for patients andfamilies impacted by this devastating disease."
HCC, the most common form of liver cancer, is responsible for about 90percent of the primary malignant liver tumors in adults.(1,2) Liver cancer isthe sixth most common cancer in the world and the third leading cause ofcancer-related deaths globally.(3) Over 600,000 cases of liver cancer arediagnosed globally each year.(3) In 2002, approximately 600,000 people died ofliver cancer including approximately 360,000 in China, Korea and Japan, 57,000in Europe and 13,000 in the United States.(4) Risk factors for liver cancerinclude ongoing (chronic) infection with hepatitis B virus (HBV) and/orhepatitis C virus (HCV).(5)
About the Asia-Pacific Liver Cancer Study
This double-blind, randomized, placebo-controlled Phase 3 trial wasdesigned to evaluate Nexavar in patients with advanced HCC, or primary livercancer, who had no prior systemic therapy. The study enrolled 226 patientsfrom sites in China, Korea and Taiwan. The primary objectives of the studywere to compare overall survival, time to progression (TTP) and progressionfree survival (PFS) in patients administered Nexavar 400 mg twice daily versuspatients administered placebo.
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 kinasesknown to be involved in both cell proliferation (growth) and angiogenesis(blood supply) -- two important processes that enable cancer growth. Thesekinases included Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3and RET. Preclinical models have also demonstrated that Raf/MEK/ERK has a rolein HCC; therefore blocking signaling through Raf-1 may offer therapeuticbenefits in HCC.
Nexavar is currently approved in more than 50 countries, including theUnited States and those in the European Union, for the treatment of patientswith advanced kidney cancer. Nexavar is also being evaluated by the companies,international study groups, government agencies or individual investigators asa single agent or combination treatment in a wide range of other cancers,including adjuvant therapy for kid