Phase III study of Nexavar (Bayer HealthCare) meets primary endpoint in patients with Thyroid Cancer
Detailed results from the Phase III DECISION trial investigating the use of Nexavar (sorafenib), from Bayer HealthCare, in patients with locally advanced or metastatic Thyroid Cancer show the drug significantly extended progression-free survival (PFS), 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 on placebo. Safety and tolerability in the study were generally consistent with the known profile of sorafenib. There was no statistically significant difference in overall survival between the treatment arms.
Median overall survival has not yet been reached in either arm. The most common treatment-emergent adverse events across all grades occurring in >20% of patients taking sorafenib vs. placebo were hand-foot skin reaction (76.3% vs. 9.6%), diarrhea (68.6% vs. 15.3%) and alopecia (67.1% vs. 7.7%). Results were presented at ASCO by Marcia Brose, trial PI and Assistant Professor in the Abramson Cancer Center and the Perelman School of Medicine at the University of Pennsylvania.
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