The European Commission has granted approval for the use of the tyrosine kinase inhibitor (TKI) alectinib as an adjuvant treatment for adults with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) who are at high risk of recurrence following tumor resection.
This approval is based on data from the Phase III ALINA trial, which involved 257 patients randomly assigned to receive either alectinib or platinum-based chemotherapy, with disease-free survival as the primary endpoint. Alectinib demonstrated a 76% reduction in the risk of disease recurrence or death compared to platinum-based chemotherapy in patients with completely resected IB (tumor ≥ 4 cm) to IIIA ALK-positive NSCLC.
Additionally, an exploratory analysis revealed an improvement in central nervous system disease-free survival, an important finding given the higher risk of brain metastases in individuals with ALK-positive NSCLC compared to other types of NSCLC.
This European approval follows the U.S. Food and Drug Administration (FDA) approval of alectinib as an adjuvant treatment for patients with ALK-positive NSCLC (tumors ≥ 4 cm or node positive) detected by an FDA-approved test.
Adjuvant alectinib resulted in a statistically significant and clinically meaningful improvement in disease-free survival compared with standard of care chemotherapy in patients with stage IB–IIIA in the ITT population of the ALINA trial. Adapted from Solomon BJ, et al, ESMO Congress 2023, LBA2.
References:
- https://www.roche.com/media/releases/med-cor-2024-06-10
- https://www.annalsofoncology.org/article/S0923-7534(23)04195-9/fulltext
EMA Approval
