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Nexavar (Sorafenib) Meets Efficacy Endpoint in Phase III Thyroid Cancer Trial

Treatment improves progression-free survival versus placebo (Jan. 3)

A phase III study of Nexavar (sorafenib, Bayer/Onyx) in patients with locally advanced or metastatic radioactive iodine-refractory (RAI) differentiated thyroid cancer has met its primary endpoint of a statistically significant improvement in progression-free survival compared with placebo.

The DECISION (StuDy of SorafEnib in LoCally Advanced or MetastatIc PatientS With Radioactive Iodine-Refractory ThyrOid CaNcer) trial was a randomized, placebo-controlled study involving 417 patients with locally advanced or metastatic, radioactive iodine-refractory, differentiated thyroid cancer (papillary, follicular, Hürthle cell, and poorly differentiated) who had received no prior chemotherapy, tyrosine kinase inhibitors, monoclonal antibodies that target vascular endothelial growth factor (VEGF) or the VEGF receptor, or other targeted agents for thyroid cancer.

The patients were randomly assigned to receive treatment with 400 mg of oral Nexavar twice daily or matching placebo. At the time of progression, patients receiving placebo had the option to cross over to Nexavar at the discretion of the investigator, based on the patient’s clinical status. The study’s primary endpoint was progression-free survival, as defined by Response Evaluation Criteria in Solid Tumors (RECIST).

Nexavar (sorafenib) is approved in the U.S. for the treatment of patients with unresectable hepatocellular carcinoma and for the treatment of patients with advanced renal cell carcinoma. The drug is believed to inhibit both the tumor cell and tumor vasculature. In preclinical studies, Nexavar was shown to inhibit multiple kinases thought to be involved in both cell proliferation and angiogenesis — 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.

Source: Onyx Pharmaceuticals; January 3, 2013.

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Decision supported by data from more than 4,000 patients