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Nexavar data to be presented at American Society of Clinical Oncology


Bayer HealthCare Pharmaceuticals, Inc. and Onyx Pharmaceuticals, Inc. today announced that more than 70 studies evaluating the use of Nexavar (sorafenib) tablets will be presented at the 2010 American Society of Clinical Oncology (ASCO) annual meeting, June 4-8, 2010, in Chicago, IL.

“Bayer and Onyx are encouraged by the number and breadth of studies involving Nexavar that are being presented at ASCO,” said Dimitris Voliotis, vice president, Global Clinical Development Oncology, Bayer HealthCare. “We have built a strong foundation with Nexavar in the treatment of patients with unresectable liver cancer and advanced kidney cancer and are committed to continuing research across tumor types and in a variety of treatment settings to determine the full potential of this therapy for cancer patients.”

Nexavar data highlights include:

Hepatocellular Carcinoma (HCC)
• Sorafenib or Placebo in Combination with Transarterial Chemoembolization (TACE) for Intermediate-Stage Hepatocellular Carcinoma (SPACE)
o Professor Riccardo Lencioni, Division of Diagnostic and Interventional Radiology, Cisanello University Hospital, Pisa, Italy
o Abstract TPS178, Trials in Progress Poster Session, Clinical Trials Special Session
o Monday, June 7, 2010, 8:00 a.m.-12:00 p.m., S Hall A2

•  alpha-Fetoprotein (AFP) and Bilirubin Levels Efficacy and Safety of Sorafenib in Patients with Advanced Hepatocellular Carcinoma; Subgroup Analysis of the SHARP Trial by Baseline Transaminase (ALT/AST)/
o Jean-Luc Raoul, M.D., PhD, Centre Eugene Marquis, Rennes, France
o Abstract 4051, General Poster Session, Gastrointestinal (Noncolorectal) Cancer Track
o Sunday, June 6, 2010, 2:00-6:00 p.m., S Hall A2

Renal Cell Carcinoma (RCC)
• Long-term Sorafenib Safety Profile in More Than 700 Patients with Renal-Cell Carcinoma Treated for 12 to 42 Months
o Thomas E. Hutson, DO, PharmD, FACP Texas Oncology, PA, Baylor Sammons Cancer Center, Baylor University Medical Center Dallas, Texas
o Abstract 4614, General Poster Session, Genitourinary Cancer Track
o Monday, June 7, 2010, 1:00-5:00 p.m., S Hall A2

Lung Cancer
• Sorafenib Treatment Efficacy and KRAS Biomarker Status in the Biomarker-Integrated Approaches of Targeted Therapy for Lung Cancer Elimination (BATTLE) trial.
o Roy Herbst, M.D., Ph.D., Department of Thoracic/Head and Neck Medical Oncology, MD Anderson Cancer Center, Houston, Texas
o Abstract 7609, General Poster Session, Lung Cancer – Metastatic Track
o Sunday, June 6, 2010, 8:00 a.m.-12:00 p.m., S Hall A2

Breast Cancer
• Multivariate Analysis (MVA) of Progression-Free Survival (PFS) in 2 Phase 2b, Multinational, Double-Blind, Randomized, Placebo-Controlled Trials Evaluating Sorafenib Plus Standard Chemotherapy in Patients with HER-2 Negative Locally advanced or Metastatic Breast Cancer.
o William John Gradishar, M.D., Northwestern University Feinberg School of Medicine, Chicago, Illinois
o Abstract 1073, General Poster Session, Breast Cancer Track
o Saturday, June 5, 2010, 2:00-6:00 p.m., S Hall A2

• A Regional Subgroup Analysis of a Multinational, Double-Blind, Randomized, Placebo Controlled, Phase 2b Study Evaluating Sorafenib (SOR) with Paclitaxel (PAC) in Patients (pts) with Advanced Breast Cancer (BC).
o Tarini Prasad Sahoo, M.D., Jawaharlal Nehru Cancer Hospital & Research Centre, Bhopal, India
o Abstract 1114, General Poster Session, Breast Cancer Track
o Saturday, June 5, 2010, 2:00-6:00 p.m., S Hall A2

• Management of Hand-Foot Skin Reaction (HFSR)/Hand-Foot Syndrome (HFS) in SOLTI-0701: A Double-Blind, Randomized Phase 2b Study Comparing Sorafenib vs Placebo in Combination with Capecitabine in Patients with Advanced Breast Cancer.
o Patricia Gomez, M.D., Breast Cancer Center, Vall d’Hebron University Hospital, Barcelona, Spain
o Abstract 1083, General Poster Session, Breast Cancer Track
o Saturday, June 5, 2010, 2:00-6:00 p.m., S Hall A2

“With more than 70 investigator and company sponsored studies being presented at ASCO, we look forward to continuing our work with investigators to understand how Nexavar may fit into other areas of the therapeutic landscape, particularly with respect to how biomarkers status may guide selection of therapy, which is a step toward personalized medicine,” said Ted W. Love, M.D., Executive Vice President and Head of Research and Development at Onyx Pharmaceuticals.

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Bayer Healthcare

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