Nexavar Study Demonstrates Significant Improvement In Overall Survival In Patients With Liver Cancer

Main Category: Liver Disease / Hepatitis
Also Included In: Cancer / Oncology;  Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 26 Jul 2008 - 1:00 PDT

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Bayer HealthCare AG and Onyx Pharmaceuticals, Inc. announced that The New England Journal of Medicine published landmark results of a Nexavar study in liver cancer. The data of the Phase III trial showed that Nexavar® (sorafenib) tablets decreased the absolute risk of death by 31 percent in patients with unresectable hepatocellular carcinoma (HCC), or liver cancer, versus patients who received placebo. This represents a 44 percent improvement in median overall survival for patients treated with Nexavar. Based on the strength of these data, Nexavar was approved for HCC in the U.S. and Europe at the end of last year.

"Despite advances in the management of many other cancers, liver cancer has remained a treatment challenge, due to a lack of systemic therapies to extend life and limited opportunity for surgical intervention," said Dr. Josep M. Llovet, co-principal investigator of the study and professor of research, Barcelona Clinic Liver Cancer (BCLC) Group, IDIBAPS, Liver Unit, Hospital Clinic Barcelona; director of research, HCC Program, associate professor of Medicine, Mount Sinai School of Medicine, New York. "This landmark study reflects a new systemic standard of care using Nexavar in the first-line management of liver cancer."

"The number of lives lost to liver cancer continues to increase globally, due to the prevalence of hepatitis B and C infections," said Jordi Bruix, co-principal investigator and director of the Barcelona Clinic Liver Cancer (BCLC) Group; senior consultant, Liver Unit, Hospital Clinic of Barcelona. "We are encouraged that there is a new treatment option available for liver cancer that has clearly demonstrated a survival benefit in this patient population."

The international, Phase III, 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 (ASCO) 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). No indication of imbalances was observed with regard to serious adverse events (SAEs) between the Nexavar and placebo-treated groups. The most commonly observed serious adverse events in patients receiving Nexavar were diarrhea and hand-foot-skin reaction.

About HCC

HCC, the most common form of liver cancer, 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 (about 54,000 in Europe, 15,000 in the United States, and 400,000 in China, South Korea and Japan) and incidence is increasing. In 2002, approximately 600,000 people died of liver cancer including 57,000 in Europe, 13,000 in the United States, and approximately 370,000 in China, South Korea and Japan. Currently, the 5-year survival rate for patients with liver cancer in Europe is less than 8 percent. The 5-year survival rate for liver cancer patients is 11 percent in the United States, and less than 10 percent in Asia among patients with unresectable tumors.

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. Preclinical models have also demonstrated that Raf/MEK/ERK has a role in HCC; therefore blocking signaling through Raf-1 may offer therapeutic benefits in HCC.

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. In Europe, Nexavar is approved for the treatment of hepatocellular carcinoma and for the treatment of patients with advanced renal cell carcinoma (RCC) who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.

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 non-small cell lung cancer (NSCLC), metastatic melanoma, breast cancer and, as an adjuvant therapy, for kidney cancer and liver cancer.

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®, a small molecule drug. For more information about Onyx, visit the company's website at: http://www.onyx-pharm.com.

About Bayer HealthCare

The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma AG. Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at http://www.bayerhealthcare.com.

Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at http://www.bayerscheringpharma.de.

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup 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 Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.