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Bayer and Onyx continue clinical investigation of sorafenib:
Enrollment initiated in international phase III study
Leverkusen, August 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.
About Onyx Pharmaceuticals, Inc.
Onyx Pharmaceuticals, Inc. is a biopharmaceutical company committed to
improving the lives of people with cancer. The company, in collaboration with
Bayer HealthCare Pharmaceuticals, Inc., is developing and marketing Nexavar®
(sorafenib) tablets, a small molecule drug. For more information about Onyx,
visit the company's website at www.onyx-pharm.com.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of
health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary
of Bayer AG, is one of the world's leading, innovative companies in the
healthcare and medical products industry and is based in Leverkusen, Germany.
The company combines the global activities of the Animal Health, Consumer Care,
Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business
operates under the name Bayer Schering Pharma. Bayer HealthCare's aim is to
discover and manufacture products that will improve human and animal health
worldwide. Find more information at www.bayerhealthcare.com.
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company.
Its research and business activities are focused on the following areas:
Diagnostic Imaging, General Medicine, Specialty Medicine and Women's
Healthcare. With innovative products, Bayer Schering Pharma aims for leading
positions in specialized markets worldwide. Using new ideas, Bayer Schering
Pharma aims to make a contribution to medical progress and strives to improve
the quality of life. Find more information at www.bayerscheringpharma.de.
