WAYNE, N.J. and EMERYVILLE, Calif., Aug. 21 Bayer HealthCare Pharmaceuticals, Inc. and Onyx Pharmaceuticals, Inc.(Nasdaq: ONXX) today announced the companies have begun enrolling patients inthe STORM Sorafenib as Adjuvant Treatment in the Prevention of Recurrence ofHepatocellular Carcinoma trial. The randomized, double-blind,placebo-controlled Phase 3 study is evaluating Nexavar(R) (sorafenib) tabletsas adjuvant treatment, which is treatment following surgery or localradiation, for patients with hepatocellular carcinoma (HCC), or primary livercancer.
"Nexavar is the only systemic therapy with proven efficacy andtolerability in HCC across multiple patient populations," said DimitrisVoliotis, MD, vice president, Nexavar Clinical Development, Bayer HealthCarePharmaceuticals. "Liver cancer is the third largest global cancer killerworldwide and there is a significant need for new therapies that can be usedat all stages in the course of the disease to delay disease progression andprolong life."
In addition, the U.S. Food and Drug Administration (FDA) has completed aSpecial Protocol Assessment (SPA) for the STORM trial. An SPA is a writtenagreement on the design and size of a clinical trial intended to form thebasis for a new drug application.
Phase 3 Trial Design
The international multicenter study is expected to enroll approximately1,100 patients and will include patients who have received surgical resectionor local ablation. The study will look at whether providing oral Nexavar inthe adjuvant setting delays the time to recurrence and increases overallsurvival. The primary endpoint of the study is recurrence free survival.Secondary endpoints include overall survival, time to recurrence,patient-reported outcomes, plasma biomarkers, safety and tolerability.
The study is enrolling patients with all HCC histologies. Patients will berandomized to receive 400 mg of Nexavar twice daily or matching placebo for upto four years. The study will be conducted at more than 200 sites in NorthAmerica, South America, Europe and the Asia-Pacific region, including Japan.For information about enrolling in the study, please visithttp://www.clinicaltrials.gov.
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 600,000cases of liver cancer are diagnosed worldwide each year (more than 400,000 inChina, South Korea, Japan and Taiwan, 54,000 in the European Union, and 15,000in the United States) and the incidence is increasing. In 2002, approximately600,000 people died of liver cancer including approximately 370,000 in China,South Korea and Japan, 57,000 in the European Union, and 13,000 in the UnitedStates.(1,2)
Currently there are no adjuvant treatments with proven benefit in HCC andhalf of the patients who have undergone surgical resection or local ablationwill see their tumors return within three years and 70 percent will see theirtumors return within five years.(3)
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.
Nexavar is currently approved in more than 40 countries for liver cancerand in more than 70 countries for the treatment of patients with advancedkidney cancer. Nexavar is also being evaluated by the companies,international study groups, government agencies and individual investigatorsas a single agent or c