Phase 3 Trial Design
The multicenter, randomized, double-blind, placebo-controlled Phase 3 study enrolled patients with unresectable stage III or stage IV melanoma at more than 200 clinical sites in the United States and Australia. The primary efficacy endpoint was overall survival, and secondary endpoints included progression-free survival and response rate.
Patients were randomized to receive 400 mg oral Nexavar twice daily or placebo, in addition to two chemotherapeutic agents - carboplatin and paclitaxel. Following 10 cycles of Nexavar or placebo plus chemotherapy, patients who achieved a response to the combination continued in a maintenance phase where Nexavar or placebo was administered as a single agent until disease progression.
In 2007, more than 108,000 people worldwide (about 59,000 Americans) were diagnosed with melanoma and more than 40,000 of them (about 8,110 Americans) died from the disease. In the United States, the percentage of people who develop melanoma has more than doubled in the past 20 years. Melanoma accounts for about four percent of skin cancer cases but causes about 75 percent of skin cancer deaths.
Nexavar's Differentiated Mechanism
Nexavar targets both the tumor cell and tumor vasculature. In preclinical studies, Nexavar has been shown to target members of two classes of kinases known 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 is currently approved in more than 70 countries for the treatment of patients with liver cancer and in more than 80 countries for the treatment of patients with advanced kidney cancer. Nexavar is also being evaluated by the companies, international study groups, g
|SOURCE Onyx Pharmaceuticals, Inc.; Bayer HealthCare Pharmaceuticals|
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