Piotr Wysocki: Adjuvant treatment with Alectinib in resected ALK-positive non-small cell lung cancer – interim analysis results of ALINA trial published in NEJM

Piotr Wysocki, Professor of Medicine and Head of the Department of Oncology at Jagiellonian University Hospital, shared on LinkedIn:

“Wu Y-L published the results of a preplanned interim analysis of the ALINA trial. This phase III clinical study enrolled 257 patients with completely resected, histologically confirmed (IB (tumors ≥4 cm), II, or IIIA) non-small cell lung cancer (NSCLC) and documented ALK-positive disease. Patients were randomly assigned in a 1:1 ratio to receive either oral Alectinib (for two years) or intravenous platinum-based chemotherapy (four 21-day cycles). The primary endpoint was disease-free survival (DFS), and secondary endpoints included overall survival and safety.

After a median follow-up of 27.8 months, the 2-year DFS rates were 93.8% and 63.0%, and the 3-year DFS rates were 88.3% and 53.5% in the Alectinib and chemotherapy groups, respectively. This translated into a HR for DFS of 0.24 (95%CI 0.13-0.45). The most common site of recurrence was the brain (4 patients in the Alectinib group and 14 in the chemotherapy group), with HR for CNS disease of 0.22 (95% CI 0.08-0.58) in favor of Alectinib. The safety profile of Alectinib was similar to that of palliative treatment, with adverse events leading to dose reduction, interruption, or discontinuation reported in 25.8%, 27.3%, and 5.5% of the patients, respectively.

Besides ADAURA, ALINA is the second trial of adjuvant targeted therapy in mutated oncogene-driven NSCLC, which significantly improves patients’ outcomes in terms of disease recurrence. Moreover, the superiority of Alectinib was demonstrated compared to chemotherapy, which was more challenging than the construction of the ADAURA trial, which compared Osimertinib to a placebo in EGFR-mutated NSCLC. The huge improvement in DFS is very promising in the context of awaited overall survival results, representing the ultimate endpoint in studies evaluating curative treatment strategies.”

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Source: Piotr Wysocki/LinkedIn