New Analyses Confirm Nexavar's Efficacy and Safety in Multiple Patient Subsets With Liver Cancer
31 October 2008 - 11:00PM
PR Newswire (US)
- Subanalyses from the Phase 3 SHARP and Asia-Pacific trials to be
presented at 59th Annual Meeting of the American Association for
the Study of Liver Diseases - WAYNE, N.J. and EMERYVILLE, Calif.,
Oct. 31 /PRNewswire-FirstCall/ -- Bayer HealthCare Pharmaceuticals,
Inc. and Onyx Pharmaceuticals, Inc. (NASDAQ:ONXX) today announced
that new Nexavar data will be presented at the upcoming 59th Annual
Meeting of the American Association for the Study of Live Diseases
(AASLD) demonstrating the clinical application of Nexavar(R)
(sorafenib) tablets in multiple patient subsets with hepatocellular
carcinoma (HCC), or liver cancer. Nexavar is the only systemic
treatment to demonstrate prolonged overall survival in unresectable
HCC and is currently approved in more than 60 countries for the
treatment of the disease. Data will be presented evaluating
specific patient subpopulations from the Phase 3 SHARP (Sorafenib
HCC Assessment Randomized Protocol) and Asia Pacific trials. The
trials enrolled 602 and 226 patients, respectively, with advanced,
unresectable HCC who had not received prior systemic therapy.
Patients in both studies were randomized to receive either Nexavar
400 mg twice daily or placebo. Data from both Phase 3 trials
demonstrated that patients treated with Nexavar experienced a
significant improvement in overall survival; 44% (HR=0.69;
p-value=0.0006) in the SHARP trial and 47% (HR=0.68; p-value=0.014)
in the Asia Pacific trial. "The SHARP and Asia Pacific trials
continue to increase our understanding and provide clinical
confirmation of the efficacy, safety and clinical benefit of
Nexavar in patients with liver cancer," said Mark Gelder, MD, vice
president, Therapeutic Area Oncology, Bayer HealthCare
Pharmaceuticals. "As leaders in the liver cancer field, Bayer and
Onyx are committed to evaluating these data comprehensively in
order to maximize the potential benefit Nexavar may offer to these
patients." Nexavar data will include: Sorafenib is Effective in
Patients from the Asia-Pacific Region with Hepatocellular Carcinoma
(HCC): Subgroup Analysis of Effect of Macroscopic Vascular
Invasion, Extrahepatic Spread, and ECOG Performance Status on
Outcome Yoon-Koo Kang - ASAN Medical Center, Songpa-gu, Seoul,
South Korea. Monday, November 3, 2008, 8 a.m. - 5:30 p.m. PDT, West
Hall Poster #1505 Data presented in this subanalysis demonstrated
that Nexavar is effective for the treatment of HCC in patients from
the Asia-Pacific region (n=150) with a safety profile consistent
with the overall study population, independent of baseline ECOG
performance status and the presence or absence of macroscopic
vascular invasion (MVI) and/or extrahepatic spread (EHS). Sorafenib
for the Treatment of Alcohol-Related Hepatocellular Carcinoma
(HCC): Subanalysis of the Phase III SHARP Trial Dr. Antonio Craxi
Azienda Ospedaliera Universitaria "Paolo Giaccone", Palermo, Italy.
Monday, November 3, 2008, 8 a.m. - 5:30 p.m. PDT, West Hall Poster
#1493 Alcohol-related cirrhosis is a major etiologic factor for
HCC. Investigators performed a subgroup analysis of patients with
alcohol-related HCC who were enrolled in the SHARP trial. Data from
this subanalysis demonstrated that Nexavar treatment is effective
in patients with alcohol-related HCC (n=159) with a comparable
safety profile to the overall SHARP study population. "With a
growing body of Nexavar data and proven efficacy in HCC,
investigators are interested in further exploring additional uses
for Nexavar in these patients," Henry Fuchs, MD, executive vice
president and chief medical officer of Onyx Pharmaceuticals. "Bayer
and Onyx are committed to unlocking the potential of Nexavar in HCC
in order to potentially improve the lives of patients at all stages
and origins of this deadly disease." Additional data include:
Biomarkers Predicting Outcome of Patients with Hepatocellular
Carcinoma: Results from the Randomized Phase III SHARP Trial Dr.
Josep Llovet, Barcelona Clinic Liver Cancer (BCLC) Group, Liver
Unit, CIBERehd, IDIBAPS, Hospital Clinic Barcelona, Barcelona,
Spain; Mount Sinai Liver Cancer Program, Mount Sinai School of
Medicine, New York. Monday, November 3, 2008, 8:15 - 8:30 a.m. PDT,
General Session Room Abstract #149, Presidential Plenary
Identification of biomarkers predicting prognosis and/or response
to treatment in patients with HCC may facilitate a more
personalized approach to medicine. In a retrospective, exploratory
analysis of a subset of the patients with HCC from the trial,
investigators examined several biomarkers that may predict
prognosis and/or response to treatment. Nexavar's Differentiated
Mechanism Nexavar, an oral anti-cancer therapy, is currently
approved in more than 60 countries for liver cancer and in more
than 70 countries for the treatment of patients with advanced
kidney cancer. 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 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 other cancers, including metastatic melanoma, breast
cancer and as an adjuvant therapy for kidney cancer and liver
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. DATASOURCE: Bayer HealthCare
Pharmaceuticals, Inc.; Onyx Pharmaceuticals, Inc. CONTACT: David
Freundel of Bayer HealthCare Pharmaceuticals, Inc.,
+1-917-806-6625; or Julie Wood of Onyx Pharmaceuticals, Inc.,
+1-510-597-6505; or Geoff Curtis of WeissComm Partners,
+1-312-550-8138, for Bayer HealthCare Pharmaceuticals, Inc. and
Onyx Pharmaceuticals, Inc. Web site: http://www.onyx-pharm.com/
http://www.nexavar.com/
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