Nexavar Shows Promise in Phase 3 Thyroid Cancer Trial
Bayer and Onyx announced that a Phase 3 trial of Nexavar (sorafenib) tablets in patients with locally advanced or metastatic radioactive iodine-refractory (RAI) differentiated thyroid cancer has met its primary endpoint of a statistically significant improvement of progression-free survival. Nexavar has been shown to inhibit multiple kinases thought to be involved in both cell proliferation and angiogenesis.
The DECISION (stuDy of sorafEnib in loCally advanced or metastatIc patientS with radioactive Iodine refractory thyrOid caNcer) trial was an international, multicenter, randomized, placebo-controlled study that randomized 417 patients with locally advanced or metastatic, radioactive iodine-refractory, differentiated thyroid cancer (papillary, follicular, Hurthle cell and poorly differentiated) who had received no prior chemotherapy, tyrosine kinase inhibitors, monoclonal antibodies that target VEGF or VEGF receptor, or other targeted agents for thyroid cancer. Patients were randomized to receive 400mg 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 primary endpoint of the study was progression-free survival, as defined by Response Evaluation Criteria in Solid Tumors (RECIST).
Nexavar is approved for the treatment of patients with unresectable hepatocellular carcinoma and for the treatment of patients with advanced renal cell carcinoma.