Multinational phase 3 study of ensartinib versus crizotinib for ALK-positive ALK inhibitor-naïve advanced NSCLC

The multinational phase 3 eXalt3 study compared ensartinib versus crizotinib for ALK-positive, ALK inhibitor-naïve, advanced NSCLC. Ensartinib had superior efficacy over crizotinib (mPFS 25.8 versus 12.7 months; HR 0.51; p<0.001). Among patients with central laboratory-confirmed ALK-positive NSCLC, the mPFS was not reached with ensartinib and was 12.7 months with crizotinib (HR 0.45; p<0.001). Among patients with baseline brain metastases the intracranial response rate was 63.6% with ensartinib versus 21.1% with crizotinib. The safety of both treatments was similar.