Multinational phase 3 trial of alectinib versus chemotherapy after resection of ALK-positive non-small cell lung cancer

The multinational phase 3 ALINA trial randomized patients after resection of stage IB, II, or IIIA NSCLC 1:1 to adjuvant oral alectinib for 24 months or four 21-day cycles of platinum-based chemotherapy. The primary end point was disease-free survival. Among all randomized patients, the percentage of patients alive and disease-free at 24 months was 93.6% in the alectinib group versus 63.7% in the chemotherapy group (HR 0.24; p<0.001), while among patients with stage II or IIIA disease (primary end point) the percentage of patients alive and disease-free at 24 months was 93.8% in the alectinib group versus 63.0% in the chemotherapy group (HR 0.24; p<0.001). Alectinib was associated with a clinically meaningful benefit with respect to CNS disease-free survival as compared with chemotherapy (HR 0.22; 95% CI 0.08-0.58). Data for overall survival were immature. There were no unexpected safety signals. The authors conclude that among patients with resected ALK-positive NSCLC of stage IB, II< or IIIA, adjuvant alectinib significantly improved disease-free survival as compared with platinum-based chemotherapy (quick take video summary).