KEY TAKEAWAYS
- The phase III trial aimed to compare the efficacy of adjuvant alectinib vs. chemotherapy in resected early-stage ALK+ NSCLC Asian patients.
- The primary endpoint was DFS. Other endpoints included CNS-DFS, OS, and safety.
- The result demonstrated that alectinib outperforms chemotherapy, offering longer, disease-free, brain cancer-free survival with manageable side effects.
Alectinib, a targeted therapy, has shown promise in treating advanced ALK+ non-small cell lung cancer (NSCLC). The ALINA clinical trial compares adjuvant alectinib to standard chemotherapy (CT) in patients with resected early-stage ALK+ NSCLC, specifically focusing on East Asia (South Korea, mainland China, Japan, Taiwan, and Thailand).
For the study, researchers aimed to compare the efficacy of adjuvant alectinib vs. chemotherapy in resected early-stage ALK+ NSCLC Asian patients.
The study included eligible patients aged ≥18 with ECOG PS of 0/1 and completely resected, stage IB (≥4 cm)–IIIA ALK+ NSCLC (UICC/AJCC 7th edition). Participants were randomly assigned 1:1 to receive oral alectinib 600 mg twice daily for up to 24 months or platinum-based chemotherapy for four 21-day cycles. Stratification factors were stage (IB vs II vs IIIA) and race (Asian vs non-Asian).
The primary endpoint was investigator-assessed disease-free survival(DFS), evaluated in stage II–IIIA and stage IB–IIIA populations. Additional endpoints included central nervous system (CNS) DFS, overall survival (OS), and safety.
About 140 Asian patients participated (alectinib: n=69; CT: n=71), with a median follow-up of 28 months. Baseline characteristics were well-balanced between the two groups. A clinically significant improvement in disease-free survival (DFS) was noted with alectinib compared to chemotherapy in stage IB–IIIA patients (stage IB–IIIA: HR 0.39, 95% CI 0.18–0.85).
Central nervous system DFS in the same population favored alectinib (stage IB–IIIA: HR 0.24, 95% CI 0.05–1.12). Overall survival data were not mature at the time of analysis. The overall safety profile of alectinib was generally consistent with its established risk profile.
The result demonstrated that alectinib outperforms chemotherapy in Asian patients with early-stage ALK+ NSCLC, offering longer disease-free and brain cancer-free survival with manageable side effects.
Source: https://cslide.ctimeetingtech.com/asia2023/attendee/confcal/show/session/40
Clinical Trial: https://clinicaltrials.gov/study/NCT03456076
Ahn JS, Wu YL, Dziadziuszko R, Barlesi F, Nishio M, Lee DH, Lee JS, Zhong WZ, Horinouchi H, Mao W, Lu S, Wang Q, Yang CT, Korphaisarn K, Xu T, Bu L, Scalori A, Petric P, Redhead K, Solomon B; LBA1. Efficacy and safety of adjuvant alectinib vs platinum-based chemotherapy in patients from Asia with resected, early-stage ALK+ non-small cell lung cancer: A subanalysis of ALINA. ESMO Asia Congress 2023.
