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The New England Journal of Medicine Publishes Nexavar(R) Study Demonstrating Significant Improvement in Overall Survival in Patients With Liver Cancer
Date:7/23/2008

ternational Phase 3 double-blind, placebo-controlled Sorafenib HCC Assessment Randomized Protocol (SHARP) trial evaluated 602 liver cancer patients who had no prior systemic therapy. The primary endpoints of the study included overall survival and time to symptomatic progression in patients administered Nexavar versus those who received placebo. Secondary endpoints included time to progression, disease control rate and safety.

Results were first presented at the American Society of Clinical Oncology in June 2007.

Median overall survival was 10.7 months for patients who received Nexavar compared to 7.9 months for patients who received placebo (HR=0.69; p=0.0006). There was no difference in time to symptomatic progression between patient groups, based on a patient-reported assessment questionnaire.

Median time to tumor progression was 5.5 months with Nexavar versus 2.8 months with placebo (HR=0.58; p=<0.001). The most common drug-related grade 3/4 events in patients receiving Nexavar were diarrhea and hand-foot-skin reaction. No indication of imbalances was observed with regard to serious adverse events between the Nexavar and placebo-treated groups.

"Hepatocellular cancer is the second type of cancer where Nexavar has demonstrated a meaningful clinical benefit," said Dimitris Voliotis, MD, vice president, Nexavar Clinical Development, Bayer HealthCare Pharmaceuticals. "We are pleased that Nexavar is now available to patients suffering from liver cancer in the U.S. and Europe and we continue to work with worldwide regulatory authorities to secure approvals in other regions."

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 400,0
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SOURCE Bayer HealthCare Pharmaceuticals; Onyx Pharmaceuticals,Inc.
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