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Data will be presented evaluating specific patient subpopulations from thePhase 3 SHARP (Sorafenib HCC Assessment Randomized Protocol) and Asia Pacifictrials. The trials enrolled 602 and 226 patients, respectively, withadvanced, unresectable HCC who had not received prior systemic therapy.Patients in both studies were randomized to receive either Nexavar 400 mgtwice daily or placebo. Data from both Phase 3 trials demonstrated thatpatients treated with Nexavar experienced a significant improvement in overallsurvival; 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.
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"The SHARP and Asia Pacific trials continue to increase our understandingand provide clinical confirmation of the efficacy, safety and clinical benefitof Nexavar in patients with liver cancer," said Mark Gelder, MD, vicepresident, Therapeutic Area Oncology, Bayer HealthCare Pharmaceuticals. "Asleaders in the liver cancer field, Bayer and Onyx are committed to evaluatingthese data comprehensively in order to maximize the potential benefit Nexavarmay offer to these patients."
Nexavar data will include:
Sorafenib is Effective in Patients from the Asia-Pacific Region withHepatocellular Carcinoma (HCC): Subgroup Analysis of Effect of MacroscopicVascular Invasion, Extrahepatic Spread, and ECOG Performance Status on Outcome
Data presented in this subanalysis demonstrated that Nexavar is effectivefor the treatment of HCC in patients from the Asia-Pacific region (n=150) witha safety profile consistent with the overall study population, independent ofbaseline ECOG performance status and the presence or absence of macroscopicvascular invasion (MVI) and/or extrahepatic spread (EHS).
Sorafenib for the Treatment of Alcohol-Related Hepatocellular Carcinoma(HCC): Subanalysis of the Phase III SHARP Trial
Alcohol-related cirrhosis is a major etiologic factor for HCC.Investigators performed a subgroup analysis of patients with alcohol-relatedHCC who were enrolled in the SHARP trial. Data from this subanalysisdemonstrated that Nexavar treatment is effective in patients withalcohol-related HCC (n=159) with a comparable safety profile to the overallSHARP study population.
"With a growing body of Nexavar data and proven efficacy in HCC,investigators are interested in further exploring additional uses for Nexavarin these patients," Henry Fuchs, MD, executive vice president and chiefmedical officer of Onyx Pharmaceuticals. "Bayer and Onyx are committed tounlocking the potential of Nexavar in HCC in order to potentially improve thelives 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
Identification of biomarkers predicting prognosis and/or response totreatment in patients with HCC may facilitate a more personalized approach tomedicine. In a retrospective, exploratory analysis of a subset of thepatients with HCC from the trial, investigators examined several biomarkersthat may predict prognosis and/or response to treatment.
Nexavar's Differentiated Mechanism
Nexavar, an oral anti-cancer therapy, is currently approved in more than60 countries for liver cancer and in more than 70 countries for the treatmentof patients with advanced kidney cancer. Nexavar targets both the tumor celland tumor vasculature. In preclinical studies, Nexavar has been shown totarget members of two classes of kinases known to be involved in both cellproliferation (growth) and angiogenesis (blood supply) -- two importantprocesses 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 studygroups, government agencies and individual investigators as a single agent orcombination treatment in a wide range of other cancers, including metastaticmelanoma, breast cancer and as an adjuvant therapy for kidney cancer and livercancer.
Important Safety Considerations For Patients Taking Nexavar
Based on the currently approved U.S. package insert for the treatment ofpatients with unresectable hepatocellular carcinoma, hypertension may occurearly in the course of therapy and blood pressure should be monitored weeklyduring the first six weeks of therapy and treated as needed. Bleeding with afatal outcome from any site was reported in 2.4% for Nexavar and 4% inplacebo. The incidence of treatment-emergent cardiac ischemia/infarction was2.7% for Nexavar vs. 1.3% for placebo. Most common adverse events reportedwith 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 ofchild-bearing potential should be advised to avoid becoming pregnant andadvised against breast-feeding. In cases of any severe or persistent sideeffects, temporary treatment interruption, dose modification or permanentdiscontinuation should be considered.
For information about Nexavar including U.S. Nexavar prescribinginformation, 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 pharmaceuticalsunit of Bayer HealthCare LLC, a division of Bayer AG. One of the world'sleading, innovative companies in the healthcare and medical products industry,Bayer HealthCare combines the global activities of the Animal Health, ConsumerCare, Diabetes Care, and Pharmaceuticals divisions. In the U.S., BayerHealthCare Pharmaceuticals comprises the following business units: Women'sHealthcare, Diagnostic Imaging, Specialized Therapeutics,Hematology/Cardiology and Oncology. The company's aim is to discover andmanufacture 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 toimproving the lives of people with cancer. The company, in collaboration withBayer 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 currentassumptions and forecasts made by Bayer Group management. Various known andunknown risks, uncertainties and other factors could lead to materialdifferences between the actual future results, financial situation,development or performance of the company and the estimates given here. Thesefactors include those discussed in our annual and interim reports filed withthe Frankfurt Stock Exchange. The company assumes no liability whatsoever toupdate these forward-looking statements or to conform them to future events ordevelopments.
This news release also contains "forward-looking statements" of Onyxwithin the meaning of the federal securities laws. These forward-lookingstatements include without limitation, statements regarding the timing,progress and results of the clinical development, safety, regulatoryprocesses, and commercialization efforts of Nexavar. These statements aresubject to risks and uncertainties that could cause actual results and eventsto differ materially from those anticipated. Reference should be made toOnyx's Annual Report on Form 10-K for the year ended December 31, 2007, filedwith the Securities and Exchange Commission under the heading "Risk Factors"and Onyx's Quarterly Reports on Form 10-Q for a more detailed description ofsuch factors. Readers are cautioned not to place undue reliance on theseforward- looking statements that speak only as of the date of this release.Onyx undertakes no obligation to update publicly any forward-lookingstatements to reflect new information, events, or circumstances after the dateof this release except as required by law.
Nexavar(R) (sorafenib) tablets is a registered trademark of BayerHealthCare Pharmaceuticals, Inc.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
SOURCE Bayer HealthCare Pharmaceuticals, Inc.; Onyx Pharmaceuticals, Inc.
