PDF / 116 KB 
collectBayerNews_20080516_0215_en.pdf BayerNews_20080516_0215_en.pdf
Berlin, May 16, 2008 - Bayer HealthCare and Onyx Pharmaceuticals, Inc. today
announced more than 40 data presentations at the 2008 American Society of
Clinical Oncology (ASCO) annual meeting demonstrating the potential for
Nexavar® (sorafenib) tablets in multiple tumor types as a single agent or in
combination with other agents.
"Along with international study groups and investigators, Bayer and Onyx are
committed to a comprehensive clinical trial program evaluating Nexavar for
additional types of cancer," Susan Kelley, MD, vice president, Therapeutic Area
Oncology, Bayer HealthCare Pharmaceuticals. "With its proven track record in
liver and kidney cancer, dual-targeted mechanism and proven tolerability, we
continue to identify important new areas where Nexavar may provide clinical
benefit for people affected by cancer."
"Data at ASCO will expand upon and support the proven efficacy and tolerability
of Nexavar in liver cancer and advanced kidney cancer and provide new insight
into the potential of Nexavar in additional types of cancer," said Henry Fuchs,
M.D., Executive Vice President and Chief Medical Officer of Onyx
Pharmaceuticals. "Highlights include studies demonstrating that Nexavar extends
life for Asian patients with liver cancer; provides an effective,
well-tolerated option for elderly patients with advanced kidney cancer and may
provide benefit and warrants further study in heavily pretreated patients with
non-small cell lung cancer."
Nexavar data highlights include:
Hepatocellular Carcinoma
- Randomized Phase III trial of sorafenib versus placebo in Asian patients with
advanced hepatocellular carcinoma
o Ann Lii-Cheng, MD, PhD, department of internal medicine, National Taiwan
University Hospital, Taipei, Taiwan
o Abstract #4509, oral presentation, Monday, June 02, 2008, 4:30 - 4:45 p.m.,
E-Hall D2
- Efficacy and safety of sorafenib in patients with advanced hepatocellular
carcinoma and vascular invasion or extrahepatic spread: a subanalysis from the
SHARP trial
o Morris Sherman, MD, PhD, associate professor of medicine, University of
Toronto, Toronto, Canada
o Poster 37G, abstract #4584, poster, Monday, June 2, 2008, 8 a.m. - 12 p.m.,
S Hall A1
- Is sorafenib safe and effective in patients with hepatocellular carcinoma
(HCC) in Child-Pugh B (CPB) Cirrhosis?
o Ghassan Abou-Alfa, MD, internal medicine, Memorial Sloan Kettering Cancer
Center, New York, NY
o Poster 6, abstract #4518, poster discussion, Tuesday, June 3, 2008,
11 - 11:15 a.m., S406
- Efficacy and safety of sorafenib in patients with advanced hepatocellular
carcinoma according to ECOG performance status: a subanalysis from the SHARP
trial
o Jean-Luc Raoul, MD, PhD, Centre Eugene Marquis, Rennes, France
o Poster 38B, Abstract #4587, Monday, June 2, 2008, 8:00 a.m. - 12:00 p.m., S
Hall A1
Renal Cell Carcinoma
- Safety and efficacy of sorafenib in elderly patients ?65 years: a subset
analysis from the ARCCs expanded access program in North America
o Ronald Bukowski, MD, director of experimental therapeutics, Cleveland Clinic
CICF Taussig Cancer Center, Cleveland, OH
o Poster 17, Abstract ?5045, Sunday, June 1, 2008, 8:00 - 12:00 p.m., W375e
Lobby / 11:00 AM - 12:00 p.m., W375a
- Comparison of kidney cancer symptoms and quality of life (QoL) in renal cell
cancer (RCC) patients receiving sorafenib vs. interferon-? (IFN)
o Cezary Szczylik, MD, Central Clinical Hospital, Military Institute of Health,
Warsaw, Poland
o Poster 44E, Abstract #9603, Saturday, May 31, 2008, 2:00 - 6:00 p.m., S Hall
A1
- Updated results of a Phase 1 trial of sorafenib and bevacizumab in patients
with metastatic renal cell carcinoma (RCC)
o Jeffrey Sosman, MD, professor of medicine (hematology/oncology),
Vanderbilt-Ingram Cancer Center, Nashville, TN
o Abstract #5011, oral presentation, Saturday, May 31, 2008, 2:15 - 2:30 p.m.,
W375e
Lung Cancer
- A randomized discontinuation Phase II study of sorafenib vs placebo in
patients with non-small cell lung cancer who have failed at least two prior
chemotherapy regimens
o Joan Schiller, MD, professor and chief of the Hematology/Oncology Division at
University of Texas Southwestern and Andrea L. Simmons Distinguished Chair in
Cancer Research, Dallas, TX
o Abstract #8014, Monday, June 2, 4 - 4:15 p.m., W375e
- A Phase II trial of BAY 43-9006 in patients with platinum treated extensive
stage small cell lung cancer (E-SCLC): A SWOG (SO435) Phase II trial
o Barbara Gitlitz, MD, associate professor of clinical, director, Lung, Head
and Neck Program, USC/Norris Comprehensive Cancer Center, Los Angeles, CA
o Poster 20, abstract #8039, poster discussion, Monday, June 2, 2008, 12 - 1
p.m., W375d
Solid Tumors
- A drug interaction study of sorafenib and rapamycin in patients with advanced
malignancies
o Tara Gangadhar, MD, fellow, University of Chicago, Chicago, IL
o Poster 10A, abstract #2545, poster discussion, Sunday, June 1, 2008, 2 - 6
p.m., S Hall A1
- A phase II study: Combination of sorafenib with docetaxel and cisplatin in
the treatment of metastatic or advanced unresectable gastric and
gastroesophageal junction (GEJ) adenocarcinoma (ECOG 5203).
o Weijing Sun, MD, assistant professor of medicine, University of Pennsylvania
Philadelphia, PA), director of Upper GI and Pancreatic-biliary-hepatic Cancer
Group and the associate director of the GI Cancer Program
o Poster 23, abstract #4535, poster discussion, Tuesday, June 3, 2008, 11:30 -
11:45 a.m., S406 - Vista Room
- Activity of sorafenib (SOR) in patients (pts) with imatinib (IM) and
sunitinib (SU)-resistant (RES) gastrointestinal stromal tumors (GIST): A phase
II trial of the University of Chicago Phase II Consortium
o Lauren Wiebe, MD, fellow, University of Chicago, Chicago, IL
o Abstract #10502, oral presentation, Saturday, May 31, 2008, 8:45 - 9 a.m.
W375d
Thyroid Cancer
- A Phase II study of sorafenib in metastatic thyroid carcinoma
o Marcia S. Brose, MD, PhD, assistant professor, director of cancer genetics
laboratory, University of Pennsylvania Health System, Philadelphia, PA
o Poster 18, abstract #6026, poster discussion, Sunday, June 1, 2008, 8 a.m.
-12 p.m., E450b
Nexavar's Differentiated Mechanism
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 the treatment of
patients with unresectable 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 AG. 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.
