Adjuvant alectinib has been approved by the FDA for resected ALK-positive NSCLC


The tyrosine kinase inhibitor showed to prolong disease-free survival as compared to chemotherapy and clinically meaningful benefit with respect to CNS disease–free survival 

In the phase III, randomised, open-label ALINA trial, adjuvant alectinib, an oral ALK tyrosine kinase inhibitor (TKI), showed to significantly improve disease-free survival (DFS) compared to platinum-based chemotherapy in patients with resected ALK-positive non-small cell lung cancer (NSCLC) (N Engl J Med 2024;390:1265-1276). Based on the positive results recently published in The New England Journal of Medicine, on 18 April the Food and Drug Administration (FDA) approved the targeted agent for adjuvant treatment after tumour resection in this setting, at a recommended dose of 600 mg orally twice daily with food for 2 years or until disease recurrence or unacceptable toxicity.

The ALINA trial involved a total of 257 patients with completely resected, histologically confirmed stage IB (tumours ≥4 cm), II, or IIIA NSCLC, who were randomly assigned to receive either alectinib or intravenous platinum-based chemotherapy in four 21-day cycles. All patients had a documented ALK-positive disease by a FDA–approved or European Conformity (CE)–marked test, either locally or centrally performed. The median time from surgery to randomisation was 1.7 months.

Favourable results for alectinib confirmed the data from an interim analysis of the trial which were presented at the ESMO Congress 2023. After a median follow-up of 27.9 months, alectinib had resulted in significantly prolonged DFS as compared with platinum-based chemotherapy, both in the intention-to-treat population (hazard ratio for disease recurrence or death, 0.24; 95% confidence interval [CI], 0.13 to 0.43; P<0.001) and among patients with stage II or IIIA disease (hazard ratio, 0.24; 95% CI, 0.13 to 0.45; P<0.001). In the intention-to-treat population, 3-year disease-free survival was 88.7% in the alectinib group and 54.0% in the chemotherapy group, and the benefit was seen consistently across subgroups.

Patients with ALK-positive NSCLC are at high risk for brain metastases, which are seen in up to 50 to 60% of patients. In the ALINA trial, alectinib was associated with a clinically meaningful benefit with respect to CNS disease–free survival (hazard ratio for CNS disease recurrence or death, 0.22; 95% CI, 0.08 to 0.58). According to an editorial accompanying the publication of the study results in the same issue of the peer-reviewed journal, the effect of alectinib on the risk of CNS disease recurrence is highly meaningful, thus positioning the TKI agent “as a therapeutic breakthrough.”

Despite growing evidence of the role TKIs play in the adjuvant setting for tumours harboring actionable genetic alterations, the editorial’s authors also highlight that some uncertainties remain to be addressed including the optimal duration of treatment, long-term safety and whether chemotherapy still holds some relevance in this setting.

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