Sorafenib

Nexavar is an oral, novel multiple kinase inhibitor that targets proteins involved in both tumor cell proliferation and angiogenesis, or the formation of new blood vessels that support the growth of cancer cells. Given Nexavar’s tolerability, combinability and convenient oral administration – as well as its efficacy in two difficult-to-treat cancers – we are working with our partner Bayer to implement a clinical development program designed to assess Nexavar’s applicability across multiple tumor types, including lung, thyroid, breast, colorectal, and ovarian cancers, along with its potential use as an adjuvant therapy for liver and kidney cancer.

In breast cancer, the companies are building on compelling Phase 2 data of Nexavar in combination with capecitabine in women with locally advanced or metastatic breast cancer and currently recruiting patients for a Phase 3 trial. The RESILIENCE trial will randomize more than 500 patients in more than 20 countries, including the United States, Brazil, Japan and Australia.  The study will evaluate the all oral regimen of Nexavar in combination with capecitabine in patients with locally advanced or metastatic HER-2 negative breast cancer who are resistant to or have failed prior taxane and an anthracycline or for whom further anthracycline is not indicated. In lung cancer, the companies are conducting a pivotal trial (MISSION) of single-agent Nexavar in third- and fourth-line patients.  In thyroid cancer, the ongoing Phase 3 trial (DECISION) is designed to confirm Nexavar’s efficacy as a single agent, as demonstrated in Phase 2 studies.  Enrollment for this trial is expected to be completed in 2011. Phase 2 studies are also being conducted in liver, breast, colorectal and ovarian cancer. 

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