Updated safety findings from the phase 3 ALINA trial (NCT03456076) further solidify adjuvant alectinib (Alecensa) as a new standard of care for patients with ALK-positive non-small cell lung cancer (NSCLC). The ALINA trial compared alectinib to platinum-based chemotherapy in this patient population. These findings were presented at the 2024 IASLC World Conference on Lung Cancer.
The study reported that any-grade adverse events (AEs) occurred in 98% of patients in the alectinib arm (n = 128) and 93% in the chemotherapy arm (n = 120). Grade 3 or 4 treatment-related AEs were less frequent in the alectinib arm (18%) compared to the chemotherapy arm (28%).
According to Hidehito Horinouchi, MD, PhD, a medical oncologist in the Department of Thoracic Oncology at the National Cancer Center Hospital in Tokyo, Japan, "Based on this safety profile in the ALINA trial, alectinib adjuvant treatment is one of the new standard treatment strategies for ALK-positive NSCLC after complete resection."
Details on Adverse Events
In the alectinib arm, AEs leading to dose reductions, dose interruptions, and treatment withdrawal occurred at rates of 26%, 27%, and 5%, respectively. The corresponding rates in the chemotherapy arm were 10%, 18%, and 13%. The most frequent AEs observed with alectinib were mainly laboratory abnormalities, such as increased levels of blood creatine phosphokinase (CPK), aspartate aminotransferase, alanine aminotransferase, and blood bilirubin. Despite these abnormalities, patients generally did not experience symptomatic AEs.
Efficacy Data from ALINA Trial
Prior data from the ALINA trial supported the FDA approval of alectinib in April 2024 as an adjuvant treatment for ALK-positive NSCLC following tumor resection in patients whose tumors are at least 4 cm or node positive. The initial presentation of the ALINA trial data at the 2023 ESMO Congress showed a disease-free survival (DFS) hazard ratio (HR) of 0.24 (95% CI, 0.13-0.43; P < .0001). A better trend was also observed in central nervous system DFS, favoring alectinib (HR, 0.22; 95% CI, 0.08-0.58).
Future Directions
When asked about potential future directions, Horinouchi mentioned the possibility of combining alectinib with chemotherapy. However, he noted that conducting such a clinical trial would be challenging due to the relatively small population of patients with ALK-positive NSCLC. He concluded that, in the long term, alectinib is likely to remain the primary treatment option in this field.
