Bayer Pharmaceuticals Corporation and Onyx Pharmaceuticals Inc. initiated a randomised, 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. 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 randomised trial," said Susan Kelley, vice president, oncology, Bayer Pharmaceuticals Corporation.
The multi-centre 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 enrol approximately 900 patients, will assess overall survival as the primary endpoint. Secondary endpoints include progression-free survival, tumour response and safety, informs the Bayer release.
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 randomised 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.
The US Food and Drug Administration 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 tumour cell and tumour vasculature. In preclinical models, Nexavar targeted members of two classes of kinases known to be involved in both tumour cell proliferation (tumour growth) and tumour angiogenesis (tumour blood supply) - two important cancer growth activities. These kinases included RAF kinase, VEGFR-2, VEGFR-3, PDGFR-ß, KIT, and FLT-3.
In 2005, Nexavar received FDA approval for the treatment of patients with advanced kidney cancer.
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 per cent of all diagnosed lung cancers are due to NSCLC. Annual deaths in the United States are estimated at 160,000.