Adjuvant Alectinib Significantly Improved Disease-Free Survival Among Patients With Resected ALK-Positive Non-Small Cell Lung Cancer

Results from the global phase 3 ALINA trial found that adjuvant alectinib significantly improved disease-free survival (DFS) among patients with resected ALK-positive stage IB, II, or IIIA non-small cell lung cancer (NSCLC). 

Although “the current recommended adjuvant treatment for patients with resected ALK-positive NSCLC is platinum-based combination chemotherapy… adjuvant chemotherapy is associated with only modest improvements in patient outcomes,” stated Yi-Long Wu, MD, Guangdong Lung Cancer Institute, Guangdong Province, China, and coauthors. “Data on the efficacy and safety of adjuvant alectinib as compared with chemotherapy in patients with resected ALK-positive NSCLC are lacking.”

In this open-label study, 257 patients with completely resected ALK-positive stage IB, II, or IIIA NSCLC were randomized on a 1-to-1 basis to receive either 600 mg of alectinib twice daily for 24 months (n = 130) or platinum-based chemotherapy (n = 127) in four 21-day cycles. The primary end point was DFS in both the intention-to-treat population and in a subgroup of patients with stage II or IIIA disease (n =231). A key exploratory end point was central nervous system (CNS) DFS. 

At a median follow-up of 27.8 months, DFS was 93.6% in the alectinib arm and 63.7% in the chemotherapy arm (hazard ratio [HR] 0.24; 95% confidence interval [CI], 0.13 to 0.43; P < .001) among patients in the intention-to-treat population. Among patients with stage II or IIIA disease, DFS was 93.8% in the alectinib arm and 63% in the chemotherapy arm (HR 0.24; 95% CI, 0.13 to 0.45; P < .001). In the alectinib arm, 4 patients experienced central nervous system-related disease recurrence compared to 14 patients in the chemotherapy arm (HR 0.22; 95% CI, 0.08 to 0.58). 

“Adjuvant alectinib showed a significant benefit with respect to disease-free survival as compared with adjuvant platinum-based chemotherapy,” concluded Dr Wu et al. “Adjuvant alectinib represents an important efficacious new treatment strategy for patients with resected ALK-positive NSCLC of stage IB, II, or IIIA.”

Source: 

Wu YL, Dziadziuszko R, Ahn JS, et al. Alectinib in resected ALK-positive non–small-cell lung cancer. N Engl J Med. Published online: April 10, 2024. doi:10.1056/NEJMoa2310532