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First Agent Ever to Demonstrate Significant Survival Benefit in Liver Cancer
Berlin - June 4, 2007 - Bayer HealthCare, a subsidiary of Bayer AG (NYSE: BAY),
and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that Nexavar®
(sorafenib) tablets significantly extended overall survival in patients with
hepatocellular carcinoma (HCC), or primary liver cancer versus those taking
placebo by 44%. Results were presented at the 43rd annual meeting of the
American Society of Clinical Oncology (ASCO). The data showed a reduced risk to
die for patients treated with Nexavar versus placebo with a hazard ratio of
0.69. Results are statistical significant (p=0.0006).
The international, Phase 3, placebo-controlled Sorafenib HCC Assessment R
andomized Protocol (SHARP) trial randomized and evaluated 602 liver cancer
patients who had no prior systemic therapy at sites in the Americas, Europe,
and Australia/New Zealand. The primary objective of the study was to compare
overall survival in patients administered Nexavar versus those administered
placebo. Median overall survival was 10.7 months in Nexavar-treated patients
compared to 7.9 months in those taking placebo.
"Because there are no therapies that significantly improve survival for the
thousands of patients with liver cancer, these findings demonstrate the
compelling study results of Nexavar as the new reference standard of care for
the first-line treatment of HCC," said Dr. Josep M. Llovet, co-principal
investigator and Professor of Research, Barcelona Clinic Liver Cancer (BCLC)
Group, IDIBAPS, Liver Unit, Hospital Clinic Barcelona; Director of Research,
HCC Program, Associate Professor of Medicine, Mount Sinai School of Medicine,
New York.
Bayer and Onyx halted the SHARP trial in February 2007 when an independent data
monitoring committee determined in a pre-scheduled analysis that the overall
survival endpoint had been met. There were no significant differences in
serious adverse events between the Nexavar and placebo-treated groups with the
most commonly observed adverse events in patients receiving Nexavar being
diarrhea and hand-foot-skin reaction. Based on the strength of the data, the
companies are now in the process of preparing applications to the U.S. Food and
Drug Administration (FDA) and European health authorities for this new
indication for Nexavar in treatment of patients with liver cancer.
"Although much progress has been made in cancer research, the number of lives
lost to liver cancer is increasing," said Dr. Jordi Bruix, co-principal
investigator and Head of the Barcelona Clinic Liver Cancer (BCLC); Senior
Consultant, Liver Unit, Hospital Clinic of Barcelona. "For that reason, these
results represent an unprecedented achievement and Nexavar could become the
first widely-approved new therapy for this difficult to treat cancer."
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. It is the fifth most common cancer in the world and the third leading
cause of cancer-related deaths globally. Over 600,000 new cases of HCC are
diagnosed globally each year (19,000 in the United States and 32,000 in the
European Union), and in 2002 approximately 600,000 people (about 13,000
Americans and 57,000 Europeans) died of HCC. Although overall cancer incidence
and mortality are decreasing in the United States, both the incidence and
mortality of liver cancer are increasing.
Nexavar's Differentiated Mechanism
Nexavar targets both the tumor cell and tumor vasculature and is the only oral
multi-kinase inhibitor that does not require patients to interrupt their
treatment schedule.
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. Preclinical models have also demonstrated that the
Raf/MEK/ERK-pathway has a role in HCC; therefore blocking signaling through
Raf-1 may offer therapeutic benefits in HCC.
Nexavar is currently approved in more than 50 countries, including the United
States and in the European Union, for the treatment of patients with advanced
kidney cancer: In Europe, Nexavar is approved 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.
In addition, Nexavar is being evaluated in clinical trials by the companies,
international study groups, government agencies and/or individual investigators
as a single agent or combination treatment in a wide range of other cancers,
including adjuvant therapy for kidney cancer, metastatic melanoma, breast
cancer and non-small cell lung cancer (NSCLC). The Phase 3 ESCAPE (Evaluation
of sorafenib, carboplatin, and paclitaxel efficacy in NSCLC) trial recently
completed enrollment of more than 900 previously untreated patients with NSCLC
of all histologies.
"HCC is the second tumor type in which Nexavar has demonstrated a clinical
benefit. We intend to move swiftly with our partner Onyx to file these data for
health authority review," said Susan Kelley, MD, Vice President, Therapeutic
Area Oncology, Bayer HealthCare Pharmaceuticals. "Our strategy of leveraging
the unique attributes of Nexavar, the only approved orally administered
anti-angiogenic that targets the Raf pathway, has led to a robust ongoing
clinical program that could bring the potent cancer fighting properties of this
oral multi-kinase inhibitor to an even broader number of patients in the coming
years."
Bayer HealthCare
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 and as
Bayer HealthCare Pharmaceuticals in the US and Canada. Bayer HealthCare's aim
is to discover and manufacture products that will improve human and animal
health worldwide.
Bayer Schering Pharma
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company.
Its research and business activities are focused on the following areas:
Diagnostic Imaging, Hematology/Cardiology, Oncology, Primary Care, Specialized
Therapeutics 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.
