Phase III Trial of Nexavar® in First-Line Advanced Non-Small Cell Lung Cancer Does Not Meet Primary Endpoint of Overall Survival
Positive Secondary Endpoint of Progression Free Survival / Clinical Trial Program in Lung Cancer Ongoing
Berlin, June 14, 2010 - Bayer HealthCare and Onyx Pharmaceuticals today announced that the final analysis of the Phase III NExUS (NSCLC research Experience Utilizing Sorafenib) trial evaluating Nexavar® (sorafenib) tablets in patients with advanced non-squamous, non-small cell lung cancer (NSCLC) showed that the trial did not meet its primary endpoint of improving overall survival in the first-line setting. NExUS evaluated Nexavar versus placebo in combination with two chemotherapeutic agents, gemcitabine and cisplatin. A positive secondary endpoint of progression-free survival (PFS) was observed in the trial. The safety and tolerability of the treatment triplet was as expected and did not show any new or unexpected toxicities. Data from this study are expected to be presented at an upcoming scientific meeting.
Nexavar is currently marketed worldwide for the treatment of advanced renal cell carcinoma (RCC), or kidney cancer, and hepatocellular carcinoma (HCC), or liver cancer.
Enrollment in NExUS commenced in Februay 2007. In 2008, based on the results seen in a previous Nexavar first-line NSCLC Phase III trial, the NExUS study protocol was amended to stop enrolling and treating squamous cell carcinoma patients. Of the squamous cell patients who were enrolled in the NExUS trial before the amendment, a higher mortality was observed in this subset of patients. This finding was consistent with what was seen in the previous trial.
Bayer and Onyx will further review the findings of this analysis to determine what, if any, impact these data might have on other ongoing clinical trials evaluating the safety and efficacy of Nexavar.
"Bayer and Onyx are disappointed with these results, in particular, for patients who are suffering from this deadly disease," said Dr. Dimitris Voliotis, Vice President, Global Clinical Development Oncology, Bayer HealthCare. "We are confident with our comprehensive clinical trial program exploring Nexavar's potential in a variety of tumor types, including lung cancer. Based on encouraging data from the recently presented prospective biomarker data and Phase II signal-generating lung cancer studies, we believe it's critical to continue our evaluation of Nexavar in combination with targeted agents and as a monotherapy in later lines of treatment in lung cancer patients."
Nexavar is being evaluated by the companies and individual investigators in a variety of treatment settings for patients with non-small cell lung cancer, including a Phase III monotherapy study in the third- and fourth-line setting and Phase II studies in combination with other therapies in the second-line setting.
NExUS Trial Design
This Phase III, randomized, double-blind, placebo-controlled study evaluated Nexavar (sorafenib) tablets in combination with the chemotherapeutic agents, gemcitabine and cisplatin, in treatment-naïve non squamous, non-small cell lung cancer patients. The primary endpoint was overall survival, and secondary endpoints included progression-free survival, tumor response and safety. Patients were randomized to receive 400 mg of oral Nexavar or matching placebo twice daily, in addition to gemcitabine and cisplatin for up to six cycles. Subsequently, patients continued in a maintenance phase where Nexavar or placebo was administered as a single agent. The study enrolled approximately 900 patients from sites throughout Europe, South America, Asia Pacific and the Middle East.
About Non-Small Cell Lung Cancer (NSCLC)
Non-small cell lung cancer accounts for 85-90% of diagnosed lung cancers and is a disease in which malignant (cancer) cells form in the tissues of the lung. It is characterized by several types of lung cancers, each of which grow and spread in different ways, including: squamous cell carcinoma, adenocarcinoma, and large cell carcinoma.
Every year 1.4 million people worldwide will be diagnosed with lung cancer. There are nearly 205,000 new cases in the United States and approximately 375,000 new cases in Europe each year. Annual deaths as a result of non small cell lung cancer are estimated at 160,000 in the United States and 342,000 in Europe.
Nexavar®, an oral anti-cancer therapy, is currently approved in more than 90 countries for liver cancer and 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 inhibits both the tumor cell and tumor vasculature. In preclinical studies, Nexavar has been shown to inhibit members of two classes of kinases thought 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.
Nexavar, which is co-developed by Bayer and Onyx Pharmaceuticals, is being evaluated by the companies, international study groups, government agencies and individual investigators as a single agent or as a combination treatment in a wide range of cancers, including lung, thyroid, breast, ovarian, and colorectal cancer and as an adjuvant therapy for liver and kidney 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® (sorafenib) tablets, a small molecule drug. For more information about Onyx, visit the company's website at www.onyx-pharm.com.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of healthcare, 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, Bayer Schering Pharma, Consumer Care and Medical Care divisions. Bayer HealthCare's aim is to discover, manufacture and market products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com.
About Bayer Schering Pharma
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 www.bayerscheringpharma.de.
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.