Plain language summary of the ALINA study results: alectinib compared with chemotherapy after surgery in people with ALK-positive non-small cell lung cancer

Wu, YL; Dziadziuszko, R; Ahn, JS; Barlesi, F; Nishio, M; Lee, DH; Lee, JS; Zhong, W; Horinouchi, H; Mao, W; Hochmair, M; de Marinis, F; Migliorino, MR; Bondarenko, I; Lu, S; Wang, Q; Ochi Lohmann, T; Xu, T; Cardona, A; Hiles, L; Noe, J; Solomon, BJ

Author(s): Wu, YL; Dziadziuszko, R; Ahn, JS; Barlesi, F; Nishio, M; Lee, DH; Lee, JS; Zhong, W; Horinouchi, H; Mao, W; Hochmair, M; de Marinis, F; Migliorino, MR; Bondarenko, I; Lu, S; Wang, Q; Ochi Lohmann, T; Xu, T; Cardona, A; Hiles, L; Noe, J; Solomon, BJ;
Details: Publication Year 2025-11,Volume 11,Issue #1,Page 2578145
Journal Title: Future Science OA
Publication Type: Commentary
Abstract: What is this summary about?In this article, we report the results of the ALINA study. This study looked at how well alectinib treatment worked in participants with ALK-positive non-small cell lung cancer (NSCLC) compared with chemotherapy after surgery.Alectinib was given to participants who had NSCLC with a specific physical change (alteration) in the Anaplastic Lymphoma Kinase (ALK) gene, or ALK-positive NSCLC, after their cancer was completely removed by surgery.Tyrosine kinases are proteins that are involved in a number of important processes in the body including cell growth, division and survival. An alteration in the ALK gene can form an ALK tyrosine kinase with uncontrolled activity, leading to cancer development.Alectinib (ALECENSA(®)) is a type of drug called a ‘tyrosine kinase inhibitor’ that helps to control the growth and spread of ALK-positive NSCLC in the body. Alectinib works by blocking ALK tyrosine kinase from switching on cell growth and survival, helping to slow down cancer growth. Alectinib is already globally approved to treat people with ALK-positive NSCLC that has spread beyond their lungs (metastatic disease).How was the study designed?The ALINA study included participants aged 18 years or older who had received surgery to completely remove their ALK-positive NSCLC. Participants could take part if they could be given platinum-based chemotherapy per local treatment guidelines. Participants who had received systemic anti-cancer treatment before could not take part.Participants were randomly allocated to get treatment with either alectinib, twice a day for two years, or with chemotherapy, for four cycles, with each cycle lasting three weeks. Both the participant and their doctor knew which treatment they received (this is known as an open-label or unblinded study).The researchers assessed if participants who were given alectinib had a longer period without their cancer returning (also known as remission) compared with participants who were given chemotherapy.As people with NSCLC often have their cancer spread from the lungs to the brain and spinal cord (known as the central nervous system, or CNS), the researchers assessed if participants who were given alectinib had a longer period without their cancer returning in their CNS compared with participants who were given chemotherapy. The researchers also assessed how long participants lived for after starting the study.To investigate the safety of both treatments, the percentage, type and seriousness of side effects that participants had whilst on treatment were noted. The percentage of participants who had side effects which led to the treatment dose being reduced, interrupted or stopped was also recorded.What were the results?In total, 257 participants took part in the study: 130 were given alectinib and 127 were given chemotherapy. Researchers found that participants who were given alectinib stayed alive and cancer-free for longer than those who were given chemotherapy. At 2 years, 94% of participants on alectinib were alive and cancer-free, compared with 64% of participants on chemotherapy. At 3 years, 89% of participants on alectinib were alive and cancer-free, compared with 54% of participants on chemotherapy.The average amount of time that participants lived for overall could not be calculated because most of them were still alive when the results were analyzed. Participants who were given alectinib were alive and cancer-free in their CNS for longer than those who were given chemotherapy. The side effects experienced by the participants who were treated with alectinib were consistent with what we already know from previous experience with alectinib.These results from the ALINA study support the use of alectinib after surgery in people with ALK-positive NSCLC and led to the approval of alectinib for use in these patients.The ALINA study is ongoing and more results will be published in the future.[Box: see text][Box: see text][Box: see text]Link to original article hereTrial registration: ClinicalTrials.gov identifier: NCT03456076.; eng
Keywords: Alina; Adjuvant treatment; Alectinib; CNS disease-free survival; Chemotherapy; Disease-free survival; Lay summary; Nsclc
Department(s): Medical Oncology
Publisher's Version: https://doi.org/10.1080/20565623.2025.2578145
Open Access at Publisher's Site: https://doi.org/10.1080/20565623.2025.2578145
Terms of Use/Rights Notice: Refer to copyright notice on published article.

Creation Date: 2026-01-09 02:59:45

Last Modified: 2026-01-09 03:01:05