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Nexavar® trial falls short of primary endpoint


Bayer HealthCare and Onyx Pharmaceuticals, Inc. today announced that a Phase III trial evaluating Nexavar® (sorafenib) tablets in patients with advanced relapsed or refractory non-squamous non-small cell lung cancer (NSCLC) whose disease progressed after two or three previous treatments, did not meet its primary endpoint of improving overall survival. An improvement in the secondary endpoint of progression-free survival (PFS) was observed. 

The study compared Nexavar plus best supportive care to placebo plus best supportive care. The safety and tolerability data were generally as expected. The data will be presented at an upcoming scientific meeting.

“While we are disappointed that the primary endpoint was not met, we believe the study results will advance the scientific knowledge in lung cancer,” said Dr. Dimitris Voliotis, Vice President, Global Clinical Development Oncology, Bayer HealthCare.

The MISSION (Monotherapy administration of Sorafenib in patients with non-small cell lung cancer) trial is an international multicenter study that randomized 703 patients with advanced relapsed or refractory non-squamous NSCLC whose disease progressed after two or three previous treatments. Patients were randomized to receive either Nexavar as single-agent or placebo. In both study arms, best supportive care was provided. The primary endpoint of the trial was overall survival, and secondary endpoints included progression-free survival, disease control rate, overall response rate, time to progression and quality of life.

The study was conducted at more than 150 sites in North America, South America, Europe, Africa and the Asia-Pacific region, including Japan.

Lung cancer is the most common cancer worldwide, with approximately 1.2 million new cases annually. There are approximately 226,000 new cases of lung cancer in the United States and approximately 417,000 in Europe each year.

NSCLC accounts for 85-90 percent 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.

Nexavar®, an oral anti-cancer therapy for liver cancer and for the treatment of patients with advanced kidney cancer, is currently approved in more than 100 countries worldwide. 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 processes involved in both the tumor cell and tumor vasculature. In preclinical studies, Nexavar has been shown to inhibit multiple kinases thought to be involved in both cell proliferation (growth) and angiogenesis (blood supply) – two important processes that enable cancer growth. These kinases include Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET.

Nexavar is also being evaluated by Bayer and Onyx, international study groups, government agencies and individual investigators in a range of cancers.


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