Multicenter phase 3 trial of apatinib versus placebo for locally advanced or metastatic RAIR-DTC

Patients with radioactive iodine-refractory differentiated thyroid cancer (RAIR-DTC) have a poor prognosis and limited treatment options. The phase 3 REALITY trial, at 21 centers in China, evaluated apatinib versus placebo for locally advanced or metastatic RAIR-DTC. The study met its primary endpoint of PFS, with median PFS 22.2 months for apatinib versus 4.5 months for placebo (HR 0.26; p<0.001). The median OS was not reached versus 29.9 months (HR 0.42; p=0.04). The safety profile of apatinib was manageable.