Horn L, Wang Z, Wu G, et al. - This open-label, multicenter, randomized, phase 3 trial demonstrated superiority of ensartinib [an oral tyrosine kinase inhibitor of anaplastic lymphoma kinase (ALK)] for both systemic and intracranial disease in patients with ALK-positive non–small cell lung cancer (NSCLC), when compared with crizotinib. Ensartinib affords a new first-line choice for patients with ALK-positive NSCLC.

• Patients 18 years of age or older with advanced, recurrent, or metastatic ALK-positive NSCLC who had not received prior therapy with an ALK inhibitor were included.

• Patients (n = 290) were randomly assigned (1:1) to ensartinib, 225 mg once daily, or crizotinib, 250 mg twice daily.

• In the intent-to-treat population, significantly longer median progression-free survival was conferred by ensartinib vs crizotinib (25.8 vs 12.7 months; hazard ratio, 0.51).

• Ensartinib offered a confirmed intracranial response rate of 64%, vs 21% with crizotinib, for patients with brain metastases at baseline.

• A favorable safety profile was displayed by ensartinib.