Multinational phase 3 trial of adjuvant alectinib versus chemotherapy in ALK-positive NSCLC: HRQOL and safety outcomes from ALINA

Among patients with resected, ALK-positive non-small cell lung cancer (NSCLC), adjuvant alectinib significantly improved disease-free survival versus platinum-based chemotherapy in the multinational phase 3 ALINA trial. Safety and health-related quality-of-life (HRQOL) outcomes from the trial have now been published. The safety-evaluable population comprised 128 patients who received alectinib and 120 patients who received chemotherapy; median duration of safety follow-up was 24.8 months in the alectinib group and 3.7 months in the chemotherapy group. The safety of adjuvant alectinib was generally consistent with its known profile. No death due to adverse events were reported in either group. There were fewer discontinuations due to adverse events with alectinib (5%) than with chemotherapy (13%). A clinically meaningful improvement from baseline was seen at week 12 for bodily pain, role physical, mental health, social functioning, and vitality SF-36v2 domains with alectinib; improvements in physical and mental HRQOL were maintained over 2 years of active treatment. The authors conclude that among patients with resected ALK-positive NSCLC, adjuvant alectinib had a manageable safety profile; HRQOL improved and was maintained over 2 years of active treatment. Together with the disease-free survival benefit seen in ALINA, these data support adjuvant alectinib as standard-of-care for patients with resected ALK-positive NSCLC.