Adjuvant alectinib versus platinum-based chemotherapy in patients from Asia with completely resected ALK-positive non-small cell lung cancer (NSCLC): an exploratory subgroup analysis of ALINA including pharmacokinetics and safety in Japanese patients

Information from the abstract

ABSTRACT Background In ALINA (NCT03456076), a global, phase III, open-label study, alectinib, a highly selective, central nervous system (CNS)-active ALK inhibitor, demonstrated strong efficacy versus chemotherapy (disease-free survival [DFS] hazard ratio [HR]: 0.24) and was well tolerated in patients with resected ALK -positive NSCLC. We present an exploratory subgroup analysis of patients from ALINA who were enrolled in Asia. Methods Eligible patients aged ≥18 years with resected stage IB (≥4 cm)–IIIA (per UICC/AJCC 7 th edition) ALK- positive NSCLC were randomized 1:1 to receive 600 mg oral alectinib (twice daily; 24 months) or intravenous platinum-based chemotherapy (four 21-day cycles). The primary endpoint was DFS. Secondary endpoints included overall survival (OS) and safety. CNS DFS was an exploratory endpoint. Safety was assessed in all randomized patients who received ≥1 dose of study drug. Results Overall, 140 patients were enrolled (alectinib arm: n=69; chemotherapy arm: n=71) in Asia (South Korea: n=49; mainland China: n=45; Japan: n=35; Taiwan: n=6; Thailand: n=5). At data cutoff (June 26, 2023), nine alectinib-treated patients (13%) and 22 chemotherapy-treated patients (31%) had experienced disease recurrence or death (DFS unstratified HR: 0.39; 95% CI: 0.18–0.85). The CNS-DFS unstratified HR was 0.24 (95% CI: 0.05–1.12). OS data were immature. No new safety concerns were observed, including in patients enrolled in Japan. Conclusions The treatment benefit of adjuvant alectinib observed in the Asia subgroup from ALINA was clinically meaningful and generally consistent with the global results, supporting that adjuvant alectinib is an efficacious treatment for patients with resected stage IB–IIIA ALK -positive NSCLC. Registered clinical trial ALINA: NCT03456076

Why this record is monitored

This record has an Impact Signal of 80/100 based on recency, source, collaboration, and bibliographic signals. It prioritizes monitoring and is not a judgment of research quality.

Related topics: Lung Cancer Treatments and Mutations · Lung Cancer Research Studies · Lung Cancer Diagnosis and Treatment