Adjuvant Alectinib Maintains Manageable Safety, QoL in NSCLC

Adjuvant treatment with alectinib (Alecensa) demonstrated a manageable safety profile and early, sustained improvements in health-related quality of life (HRQoL) over 2 years among patients with resected, ALK-positive non–small cell lung cancer (NSCLC), according to safety and HRQoL outcomes from the phase 3 ALINA trial (NCT03456076).¹

Published in The Lancet Oncology, the findings indicate that adjuvant alectinib exhibited a manageable safety profile among 128 patients in the safety-evaluable population over the treatment period. With a median safety follow-up of 24.8 months, among patients receiving alectinib, the most frequently reported grade 3 to 4 adverse events (AEs) were increased blood creatine phosphokinase (6%) and increased blood bilirubin (2%).

AEs lasting longer than 4 months, including constipation, increased blood alkaline phosphatase, increased blood bilirubin, and anemia, were predominantly grade 1 or 2 and did not lead to treatment discontinuation. No deaths due to AEs occurred in either treatment group.

Quality of Life: Early Benefits Maintained Through 2 Years

HRQoL findings also favored alectinib during the initial treatment period. At baseline, mean Mental Component Summary (MCS) scores were 45.7 with alectinib and 44.2 with chemotherapy, while mean Physical Component Summary (PCS) scores were 46.7 and 46.2, respectively.

In a posthoc mixed-effects model at week 12, alectinib was associated with clinically meaningful improvements from baseline compared with chemotherapy in bodily pain, general health, role physical, role emotional, mental health, social functioning, and vitality. Physical functioning was the only domain without a clinically meaningful between-group difference.

Over the 2-year treatment period, HRQoL improvements with alectinib were maintained. At week 96, the mean MCS score was 49.9 and the mean PCS score was 48.8, approaching the SF-36v2 general population norm of 50. Scores for bodily pain, mental health, social functioning, and vitality were also similar to the population norm.

ALINA Study Design

The global, open-label, randomized ALINA trial enrolled 257 patients with completely resected, stage IB (tumors ≥4 cm) to IIIA, ALK-positive NSCLC. Patients were randomly assigned 1:1 to oral alectinib at 600 mg twice daily for 24 months (n = 130) or 4 cycles of intravenous platinum-based chemotherapy administered every 3 weeks (n = 127). Patients were required to have an ECOG performance status of 0 or 1 and no prior systemic anticancer therapy. Safety was a secondary end point, while HRQoL was an exploratory end point assessed using the 36-item Short-Form Health Survey version 2 (SF-36v2).

The safety-evaluable population included 128 patients who received alectinib and 120 who received chemotherapy. Median treatment duration was substantially longer with alectinib at 23.9 months compared with 2.1 months with chemotherapy.

Reinforcing Alectinib as Standard of Care

In April 2024, the FDA granted approval to alectinib as adjuvant treatment following tumor resection for patients with ALK-positive NSCLC based on an earlier assessment of the ALINA trial.² The newly published findings build upon prior efficacy data from ALINA.

Most recently, a 4-year update from the trial presented at the 2025 European Society for Medical Oncology (ESMO) Congress showed that the disease-free survival (DFS) benefit with adjuvant alectinib remained durable with longer follow-up.³ At a median follow-up of 48 months in the alectinib arm and 47.4 months in the chemotherapy arm, the 4-year DFS rate was 75.5% with alectinib vs 47.0% with chemotherapy. Median DFS was not evaluable with alectinib compared with 41.4 months (95% CI, 30.6-not evaluable) with chemotherapy, corresponding to a 65% reduction in the risk of disease recurrence or death (HR, 0.35; 95% CI, 0.23-0.54).

Taken together, the longer-term efficacy findings and the newly reported safety and HRQoL outcomes further support the use of alectinib as an adjuvant treatment option for patients with resected, ALK-positive NSCLC.

“Together with the disease-free survival benefit seen in ALINA, these data support adjuvant alectinib as an important new standard-of-care for patients with resected ALK-positive NSCLC,” study authors Dziadziuszko et al concluded.

REFERENCES

1. Dziadziuszko R, Ahn JS, Barlesi F, et al. Adjuvant alectinib versus chemotherapy in resected ALK-positive non-small-cell lung cancer (ALINA): health-related quality-of-life and safety outcomes from a randomised, open-label, phase 3 trial. The Lancet Oncology. 2026;27(9):1110-1119. doi:10.1016/s1470-2045(26)00283-4

2. FDA approves alectinib as adjuvant treatment for ALK-positive non-small cell lung cancer. U.S. Food and Drug Administration. Published April 19, 2024. Accessed September 4, 2026. https://tinyurl.com/yc36tb53

3. Dziadziuszko R, Solomon BJ, Wu Y-L, et al. Updated results from the phase III ALINA study of adjuvant alectinib vs chemotherapy (chemo) in patients (pts) with early-stage ALK+ non-small cell lung cancer (NSCLC). Presented at: 2025 ESMO Congress; October 17-21, 2025; Berlin, Germany. Abstract 1787MO.