- Trial Results Confirm Efficacy for Population Most Affected by Disease - WAYNE, N.J. and EMERYVILLE, Calif., May 16
WAYNE, N.J. and EMERYVILLE, Calif., May 16 /PRNewswire-FirstCall/ -- Bayer
HealthCare Pharmaceuticals, Inc. and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX)
today announced that Nexavar(R) (sorafenib) tablets significantly improved
overall survival by 47.3 percent (HR=0.68; p-value=0.014) in patients in the
Asia-Pacific region with advanced hepatocellular carcinoma (HCC), or primary
liver cancer versus those receiving placebo. Nexavar also significantly
improved time to progression in these patients by 74 percent (HR=0.57;
P=0.001). These data were presented at the 44th annual meeting of the American
Society of Clinical Oncology (ASCO) and further confirm Nexavar's efficacy in
liver cancer.
The international, Phase 3, randomized trial evaluated efficacy and safety
of Nexavar versus placebo in 226 Asian patients with advanced HCC who had not
received prior systemic therapy. The study was designed to compare overall
survival, time to progression, time to symptomatic progression, response as
defined by RECIST criteria and safety in patients receiving Nexavar versus
placebo. Median overall survival was 6.5 months in patients treated with
Nexavar versus 4.2 months for those taking placebo. The survival benefit was
seen across multiple patient subsets analyzed, including age, extrahepatic
spread and/or macroscopic vascular invasion.
"Liver cancer in the Asia-Pacific region continues to grow because of a
high incidence of chronic hepatitis B viral infections, which now impact
approximately 275 million people in the region," said Ann-Lii Cheng, MD, PhD,
Department of Internal Medicine and Department of Oncology, National Taiwan
University Hospital, Taipei, Taiwan and principal investigator of the trial.
"Nexavar demonstrated a clear survival benefit in Asia-Pacific patients and
had comparable results to last year's SHARP trial, despite these patients in
the Asia-Pacific trial having poorer health status and more metastases."
Additional results from the trial are as follows:
-- Median time to progression was 2.8 months in Nexavar-treated patients
versus 1.4 months for those taking placebo.
-- Median time to symptomatic progression was 3.5 months in patients
treated with Nexavar versus 3.4 months for those taking placebo.
-- Disease control rate (complete response + partial response + stable
disease >/= 12 weeks) was 35 percent in Nexavar-treated patients versus
16 percent for those taking placebo.
Data from the study indicate that Nexavar was safe and well-tolerated in
patients from the Asia-Pacific region. Adverse events were low to moderate in
severity and treatment was well tolerated. The most common serious adverse
events observed in the study were hand-foot-skin reaction, diarrhea, alopecia,
fatigue, and rash/desquamation.
"These data provide further evidence that Nexavar is efficacious in liver
cancer across multiple geographical regions and independent of disease
characteristics and etiologies of underlying liver disease," said Susan
Kelley, MD, Vice President, Therapeutic Area Oncology, Bayer HealthCare
Pharmaceuticals. "Nexavar has quickly become the systemic standard of care for
liver cancer, and is the only systemic therapy that has been shown to improve
overall survival in Asian patients with liver 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. 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.(1,2)
In addition, chronic hepatitis B (HBV) and C (HCV) viral infections are
the leading causes of primary liver cancer worldwide. In the Asia-Pacific
region, more than eight percent of the general population is infected with HBV
and between two and four percent is infected with HCV.(3,4)
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 liver cancer
and in more than 70 countries for the treatment of patients with advanced
kidney cancer. 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.
Important Safety Considerations For Patients Taking Nexavar
Based on the currently approved U.S. package insert for the treatment of
patients with unresectable hepatocellular carcinoma, hypertension may occur
early in the course of therapy and blood pressure should be monitored weekly
during the first six weeks of therapy and treated as needed. Bleeding with a
fatal outcome from any site was reported in 2.4% for Nexavar and 4% in
placebo. The incidence of treatment-emergent cardiac ischemia/infarction was
2.7% for Nexavar vs. 1.3% for placebo. Most common adverse events reported
with Nexavar in patients with unresectable HCC were diarrhea, fatigue,
abdominal pain, weight loss, anorexia, nausea and hand-foot skin reaction.
Grade 3/4 adverse events were 45% for Nexavar vs. 32% for placebo. Women of
child-bearing potential should be advised to avoid becoming pregnant and
advised against breast-feeding. In cases of any severe or persistent side
effects, temporary treatment interruption, dose modification or permanent
discontinuation should be considered.
For information about Nexavar including U.S. Nexavar prescribing
information, visit http://www.nexavar.com or call 1.866.NEXAVAR
(1.866.639.2827).
About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals
unit of Bayer HealthCare LLC, a division of Bayer AG. One of the world's
leading, innovative companies in the healthcare and medical products industry,
Bayer HealthCare combines the global activities of the Animal Health, Consumer
Care, Diabetes Care, and Pharmaceuticals divisions. In the U.S., Bayer
HealthCare Pharmaceuticals comprises the following business units: Women's
Healthcare, Diagnostic Imaging, Specialized Therapeutics,
Hematology/Cardiology and Oncology. The company's aim is to discover and
manufacture products that will improve human health worldwide by diagnosing,
preventing and treating diseases.
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(R)
(sorafenib) tablets, a small molecule drug. For more information about Onyx,
visit the company's website at http://www.onyx-pharm.com.
Forward-Looking Statements
This news release contains forward-looking statements based on current
assumptions and forecasts made by Bayer Group management. Various known and
unknown risks, uncertainties and other factors could lead to material
differences between the actual future results, financial situation,
development or performance of the company and the estimates given here. These
factors include those discussed in our annual and interim reports filed with
the Frankfurt Stock Exchange. The company assumes no liability whatsoever to
update these forward-looking statements or to conform them to future events or
developments.
This news release also contains "forward-looking statements" of Onyx
within the meaning of the federal securities laws. These forward-looking
statements include without limitation, statements regarding the timing,
progress and results of the clinical development, safety, regulatory
processes, and commercialization efforts of Nexavar. These statements are
subject to risks and uncertainties that could cause actual results and events
to differ materially from those anticipated. Reference should be made to
Onyx's Annual Report on Form 10-K for the year ended December 31, 2007, filed
with the Securities and Exchange Commission under the heading "Risk Factors"
and Onyx's Quarterly Reports on Form 10-Q for a more detailed description of
such factors. Readers are cautioned not to place undue reliance on these
forward- looking statements that speak only as of the date of this release.
Onyx undertakes no obligation to update publicly any forward-looking
statements to reflect new information, events, or circumstances after the date
of this release except as required by law.
Nexavar(R) (sorafenib) tablets is a registered trademark of Bayer
HealthCare Pharmaceuticals, Inc.
(1) Ferlay J, et al., GLOBOCAN 2002. Cancer Incidence, Mortality and
Prevalence Worldwide. IARC CancerBase No.5, Version 2.0. IARCPress,
Lyon, 2004. Available at: http://www-dep.iarc.fr. Accessed May 2008.
(2) 2005 Cancer Register System (CRS) annual report,
http://crs.cph.ntu.edu.tw/crs_c/annual.html. Accessed May 12, 2008.
(3) World Health Organization, Fact Sheet N degree 164, October 2000.
http://www.who.int/mediacentre/factsheets/fs164/en/.
Accessed May 2008.
(4) Stanford University School of Medicine, Asian Liver Center, "FAQ About
Hepatitis B," February 2008.
http://liver.stanford.edu/Education/faq.html. Accessed May 2008.
SOURCE Bayer HealthCare Pharmaceuticals, Inc.; Onyx Pharmaceuticals, Inc.
