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Phase 3 Trial Initiated of Sorafenib in Non-Small Cell Lung Cancer
"Despite recent therapeutic advances, non-small cell lung cancer remains a devastating disease," said Susan Kelley, M.D., vice president, Oncology, Bayer Pharmaceuticals Corporation. "In early clinical studies, we observed preliminary activity in a small number of non-small cell lung cancer patients who received Nexavar administered in this drug combination. We look forward to exploring Nexavar in this randomized trial."
Pivotal Phase 3 Trial Design
The multicenter study will compare Nexavar when co-administered with two chemotherapeutic agents - carboplatin and paclitaxel - versus carboplatin and paclitaxel alone. The study, which is expected to enroll approximately 900 patients, will assess overall survival as the primary endpoint. Secondary endpoints include progression-free survival, tumor response and safety. Participating patients may not have received prior systemic anticancer treatment. Additionally, the study is open to patients with all histologies, or types, of NSCLC including those with squamous cell or adeno carcinomas. Patients will be randomized to receive 400 mg of oral Nexavar twice daily or matching placebo, in addition to carboplatin and paclitaxel for six cycles. Subsequently, patients will continue in a maintenance phase where Nexavar or placebo will be administered as a single agent. The study will be conducted at more than 130 sites in North America, South America, Europe and the Asia Pacific region.
Bayer and Onyx also reported today that the U.S. Food and Drug Administration (FDA) has completed a Special Protocol Assessment (SPA) for the Phase III NSCLC trial. A SPA is a written agreement on the design and size of a clinical trial intended to form the basis for a new drug application.
Nexavar is the first 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 tumor cell proliferation (tumor growth) and tumor angiogenesis (tumor blood supply) - two important cancer growth activities. These kinases included RAF kinase, VEGFR-2, VEGFR-3, PDGFR-B, KIT, and FLT-3.
In 2005, Nexavar received FDA approval for the treatment of patients with advanced kidney cancer. It is currently in Phase III clinical trials for the treatment of advanced hepatocellular carcinoma (HCC), or liver cancer, and metastatic melanoma, or skin cancer and has been studied in more than 20 tumor types and in more than 4,000 patients to date. In addition to company- sponsored trials, there are a variety of Nexavar studies being sponsored by government agencies, cooperative groups and individual investigators.
About Non-Small Cell Lung Cancer (NSCLC)
Lung cancer is the leading cause of cancer death for both men and women - claiming more lives than colon, breast, and prostate cancers combined. There are nearly 175,000 new cases of lung cancer in the United States each year; approximately 75 percent of all diagnosed lung cancers are due to NSCLC. Annual deaths in the United States are estimated at 160,000.
Source: Bayer Pharmaceuticals Corporation and Onyx Pharmaceuticals, Inc.