Oncology News Updates
New Trial to Evaluate Nexavar® as Adjuvant Therapy in Liver Cancer
Bayer News Release
Aug 21, 2008
Bayer HealthCare Pharmaceuticals, Inc. and Onyx Pharmaceuticals, Inc. today announced the start of a Phase III study with Nexavar® (sorafenib) tablets in liver cancer. The randomized, double-blind, placebo-controlled study is evaluating Nexavar as an adjuvant therapy for patients with hepatocellular carcinoma (HCC), or primary liver cancer. An adjuvant treatment is given as an additional systemic therapy after the initial tumor treatment, e.g. surgery, to fight cancer cells that may have spread.
The STORM (Sorafenib as Adjuvant Treatment in the Prevention of Recurrence of Hepatocellular Carcinoma) trial aims to further build on earlier Phase III data, which demonstrated a significant improvement in overall survival in patients with unresectable liver cancer. Based on the strength of these data, Nexavar was approved for HCC in the U.S. and Europe at the end of 2007.
“Nexavar is the only systemic therapy with proven efficacy and tolerability in HCC across multiple patient populations,” said Dimitris Voliotis, MD, Vice President, Nexavar Clinical Development, Bayer HealthCare. “Liver cancer is the third largest global cause of cancer-related deaths worldwide and there is a significant need for new therapies that can be used at all stages in the course of the disease to delay progression and prolong life.”
In addition, the U.S. Food and Drug Administration (FDA) has completed a Special Protocol Assessment (SPA) for the trial. An SPA is a written agreement between the FDA and the company that the design and size of a clinical trial are acceptable to support a New Drug Application for marketing in the United States.
About the Phase III Study
Currently there are no adjuvant treatments with proven benefit in HCC. The international multicenter study is expected to enroll approximately 1,100 patients and will include patients who previously received surgery or other procedures to remove their tumor. The study will look at whether providing oral Nexavar in the adjuvant setting delays the time to recurrence and increases overall survival. 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 be randomized to receive 400 mg of oral Nexavar twice daily or matching placebo for up to four years. The study will be conducted at more than 200 sites in North America, South America, Europe and the Asia-Pacific region. For information about enrolling in the study, please visit www.clinicaltrials.gov.
About Hepatocellular Carcinoma
Hepatocellular carcinoma is the most common form of liver cancer and is responsible for about 90 percent of the primary malignant liver tumors in adults. Liver cancer is the sixth most common cancer in the world and the third leading cause of cancer-related deaths globally. More than 600,000 cases of 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 the United States) and the incidence is increasing. In 2002, approximately 600,000 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 United States.
About Nexavar®
Nexavar® targets both the tumor cell and tumor vasculature. In preclinical studies, Nexavar has been shown to target members of two classes of kinases known to be involved in both cell proliferation (growth) and angiogenesis (blood supply) – two important processes that enable cancer growth. These kinases included Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET.
Nexavar is currently approved in more than 40 countries for liver cancer and in more than 70 countries for the treatment of patients with advanced kidney cancer. In Europe, Nexavar is approved for the treatment of hepatocellular carcinoma and for the treatment of patients with advanced renal cell carcinoma (RCC) who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy. Nexavar is also being evaluated by the companies, international study groups, government agencies and individual investigators as a single agent or combination treatment in a wide range of cancers, including metastatic melanoma, lung cancer, breast cancer and as an adjuvant therapy for kidney cancer.
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