Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. (ONXX) announced positive results from the Phase 3 DECISION trial investigating the use of Nexavar, or sorafenib, tablets in patients with locally advanced or metastatic radioactive iodine - refractory differentiated thyroid cancer.
According to the company, Sorafenib significantly extended progression-free survival, the primary endpoint of the study, compared to placebo. The median PFS was 10.8 months among patients treated with sorafenib, compared to 5.8 months among patients receiving placebo
At the time of progression, patients had the option to cross over to open-label sorafenib at the discretion of the investigator; 71% of patients in the placebo arm received open-label sorafenib after progression and 27% of patients in the sorafenib arm received open-label sorafenib after progression, the company noted.
There was no statistically significant difference in overall survival between the treatment arms, a secondary endpoint of the trial.
The data will be presented in a plenary session on June 2, 2013, at the 49th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, IL.
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