Bayer and Onyx Initiate Phase III Non-Small Cell Lung Cancer Trial Studying Nexavar (sorafenib) tablets in Combination with Two Chemotherapeutic Agents
WEST HAVEN, CT and EMERYVILLE, CA – February 16, 2006 – Bayer Pharmaceuticals Corporation (NYSE: BAY) and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced the initiation of a randomized, double-blind, placebo-controlled Phase III clinical trial studying Nexavar® (sorafenib) tablets administered in combination with the chemotherapeutic agents carboplatin and paclitaxel in patients with non-small cell lung cancer (NSCLC).
“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 III 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-β, 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.
Important Safety Considerations for Patients Taking Nexavar
Hypertension may occur early in the course of therapy and blood pressure should be monitored weekly during the first six weeks of therapy and treated as needed. Incidence of bleeding regardless of causality was 15% for Nexavar vs. 8% for placebo and the incidence of treatment-emergent cardiac ischemia/infarction was 2.9% for Nexavar vs. 0.4% for placebo. Most common treatment-emergent adverse events with Nexavar were diarrhea, rash/desquamation, fatigue, hand-foot skin reaction, alopecia, and nausea. Grade 3/4 adverse events were 38% for Nexavar vs. 28% for placebo. Women of child-bearing potential should be advised to avoid becoming pregnant and advised against breast-feeding. In cases of any severe or persistent side effects, temporary treatment interruption, dose modification or permanent discontinuation should be considered.
About Onyx Pharmaceuticals, Inc.
Onyx Pharmaceuticals, Inc. is engaged in the development of novel cancer therapies that target the molecular basis of cancer. With its collaborators, the company is developing small molecule drugs, including Nexavar with Bayer Pharmaceuticals Corporation. For more information about Onyx’s pipeline and activities, visit the company’s web site at: www.onyx-pharm.com.
About Bayer Pharmaceuticals Corporation
Bayer Pharmaceuticals Corporation (www.bayerpharma.com) is part of the worldwide operations of Bayer HealthCare AG, a subsidiary of Bayer AG.
Bayer HealthCare, with sales of approximately 8.5 billion Euro in 2004, is one of the world’s leading, innovative companies in the health care and medical products industry. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care, Diagnostics and Pharmaceuticals. Since January 1, 2006 the new Pharmaceuticals Division consists of the former Biological Products and Pharmaceuticals Division and now comprises three business units: Hematology/Cardiology, Oncology, and Primary Care. Bayer HealthCare employed 35,300 people worldwide in 2004.
Bayer Healthcare’s aim is to discover and manufacture innovative products that will improve human and animal health worldwide. The products enhance well-being and quality of life by diagnosing, preventing and treating disease.
Forward Looking Statements
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group 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 filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including its Form 20-F). Bayer assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
This news release also contains “forward-looking statements” of Onyx within the meaning of the federal securities laws. These forward-looking statements include without limitation, statements regarding the timing, progress and results of the clinical development, regulatory processes and commercialization efforts of Nexavar®. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated. Reference should be made to Onyx’s Annual Report on Form 10-K for the year ended December 31, 2004, as amended, filed with the Securities and Exchange Commission under the heading “Additional Business Risks” and Onyx’s Quarterly Reports on Form 10-Q for a more detailed description of such factors. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date of this release. Onyx undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date of this release except as required by law.
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Nexavar® (sorafenib) tablets is a registered trademark of Bayer Pharmaceuticals Corporation.
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