2006.5.3— 多吉美治疗转移性黑色素瘤和肝癌 III 期研究完成患者入组
英文全文：
3 May 2006 - Enrollment Completed in Phase III Studies of Nexavar for Patients with Metastatic Melanoma and Liver Cancer
West Haven, CT and Emeryville, CA – Bayer Pharmaceuticals Corporation (NYSE: BAY) and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced the completion of patient enrollment in two randomized, double-blind Phase III clinical trials; one administering Nexavar® (sorafenib) tablets in combination with the chemotherapeutic agents carboplatin and paclitaxel in patients with advanced metastatic melanoma and another administering Nexavar as a single agent in patients with advanced hepatocellular carcinoma (HCC), or liver cancer.
“Therapy with Nexavar could potentially provide an important advancement in the treatment of these difficult diseases, and we are pleased to have reached these milestones,” said Henry Fuchs, M.D., executive vice president and chief medical officer of Onyx Pharmaceuticals. “While the studies are still ongoing and analyses will not commence until the pre-specified number of events are reached, we look forward to generating randomized data in these indications.”
Trial Designs
The company-sponsored melanoma trial is designed to evaluate the safety and efficacy of Nexavar when co-administered with chemotherapy, and has progression-free survival as its primary endpoint. Approximately 250 patients with disease progression following one previous systemic chemotherapeutic treatment (with either dacarbazine (DTIC) or temozolomide) were enrolled into the study. In addition to a standard dosing schedule of carboplatin (AUC 6) and paclitaxel (225 mg/m2), patients were randomized to receive either 400 mg of Nexavar twice daily or matching placebo. The melanoma study includes sites in the Americas, Europe, and Australia.
The Phase III study in patients with advanced HCC is designed to measure differences in overall survival, time to symptom progression and time to tumor progression of Nexavar versus placebo. Approximately 560 patients who had not received previous systemic treatment for their disease were randomized to receive 400 mg of oral Nexavar twice daily or matching placebo. The HCC study is being conducted in the Americas, Europe, and Australia/New Zealand.
About Melanoma
Cancer of the skin (nonmelanoma and melanoma skin cancers combined) is the most common type of cancer, accounting for more than 50 percent of all cancers. In some parts of the world, especially among Western countries, melanoma is becoming more common every year. In the United States, for example, the percentage of people who develop melanoma has more than doubled in the past 20 years. Melanoma accounts for about four percent of skin cancer cases but causes about 79 percent of skin cancer deaths. In 2002, about 160,000 people worldwide (about 53,000 Americans) were diagnosed with melanoma, and more than 40,000 of them (about 7,500 Americans) died from the disease. For more information on melanoma, visit the Melanoma International Foundation (MIF) web site at: www.melanomainternational.org.
About Hepatocellular Carcinoma
Hepatocellular carcinoma, also known as primary liver cancer, is the most common form of liver cancer and is responsible for 80 percent of the primary malignant liver tumors in adults. It is the fifth most common cancer in the world. In 2002, approximately 626,000 HCC cases were reported worldwide, with 15,000 cases in the United States and 53,600 in Europe. HCC is most prevalent in developing countries, particularly in East and South-east Asia, the Pacific Basin, and sub-Saharan Africa. Of the 626,000 cases worldwide, approximately 410,000 were reported in Eastern Asia (with 346,000 in China and 40,000 in Japan alone). HCC causes more than 600,000 deaths annually worldwide. The five-year relative survival rate is about seven percent.
About Nexavar
Nexavar is an oral multi-kinase inhibitor that targets both the tumor cell and tumor vasculature. In preclinical models, Nexavar targeted 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-2, VEGFR-3, PDGFR-ß, KIT, and FLT-3.
Nexavar has been studied in more than 20 tumor types and in nearly 8,000 clinical trial patients. Nexavar is currently in Phase III clinical trials for the treatment of advanced hepatocellular carcinoma (HCC), or liver cancer, and metastatic melanoma, or skin cancer. A Phase III clinical trial in non-small cell lung cancer (NSCLC) was initiated in February 2006. In addition to company-sponsored trials, there are a variety of Nexavar studies being sponsored by government agencies, cooperative groups and individual investigators.
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