Adjuvant alectinib held its advantage in ALINA’s Asia subgroup, on 31 events and immature survival data

Nine events on alectinib against 22 on chemotherapy

ALINA randomised patients with completely resected stage IB to IIIA ALK-positive disease to either alectinib or platinum-based chemotherapy, and the Asia analysis takes the 140 patients enrolled at sites in South Korea, mainland China, Japan, Taiwan and Thailand. Sixty-nine received alectinib at 600 mg twice daily for 24 months and 71 received four 21-day cycles of chemotherapy. At the 26 June 2023 data cutoff, nine patients in the alectinib arm (13%) had experienced disease recurrence or death, against 22 in the chemotherapy arm (31%).

The whole comparison therefore rests on 31 events across both arms. The authors present the analysis as exploratory, so the figures describe what happened in the patients enrolled in Asia rather than test a hypothesis in them.

A hazard ratio of 0.39, against 0.24 in the global population

The unstratified disease-free survival hazard ratio in the Asia subgroup was 0.39, with a 95% confidence interval from 0.18 to 0.85. The upper bound stays below one, so the direction of the result is clear, but the interval is compatible with an effect anywhere from a very large reduction in recurrence to a modest one.

The corresponding figure for the full ALINA population, cited by the authors as the background to this analysis, was a disease-free survival hazard ratio of 0.24. The subgroup estimate is numerically less favourable than the global one. Nothing in the analysis attributes that difference to any cause, and no confidence interval is given for the global figure to compare it against. The authors describe the subgroup result as generally consistent with the global one rather than as a separate finding.

A brain signal pointing the same way, on an interval that crosses one

Central nervous system disease-free survival was an exploratory endpoint, and it returned an unstratified hazard ratio of 0.24 with a 95% confidence interval from 0.05 to 1.12. The point estimate matches the global disease-free survival figure, but the interval includes one, which means the result is compatible with no difference between the arms.

The authors describe alectinib as a highly selective ALK inhibitor that is active in the central nervous system, which is what makes this endpoint worth reporting. The analysis gives no number of central nervous system events in either arm to sit alongside the ratio. On the evidence presented, the brain result is a direction rather than a measurement.

Survival immature, and no pharmacokinetic figures in the abstract

Overall survival was a secondary endpoint and the data were immature at the cutoff. No survival estimate of any kind was released, and there is no follow-up duration given for the subgroup. Whether the difference in disease-free survival is accompanied by a difference in overall survival is therefore not answered by this analysis.

The paper’s title names pharmacokinetics and safety in Japanese patients, and 35 of the 140 patients were enrolled in Japan. The abstract reports that no new safety concerns were observed, including in those patients, but it carries no pharmacokinetic values, no exposure comparison between the Japanese and non-Japanese patients, and no adverse event rates for either arm. Safety was assessed in all randomised patients who received at least one dose of study drug.

What the authors conclude, and what an exploratory subgroup can carry

The analysis was designed to ask whether the global ALINA result held in the patients enrolled in Asia, and the authors answer that it did.

“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.”Nishio et al., International Journal of Lung Cancer (2026)

The weight that conclusion carries is set by the design. This is an open-label trial, the subgroup analysis is exploratory, the endpoint that drives it is disease-free survival rather than overall survival, and the estimate rests on 31 events. The analysis shows that the patients enrolled in Asia behaved like the trial as a whole. It does not establish a regional result in its own right, and with immature survival data and a brain interval that crosses one, it does not measure either survival or central nervous system protection.