ALINA is the first and only Phase III study to show an improvement in disease-free survival in patients from Asia with early-stage resected ALK-positive non-small cell lung cancer (NSCLC) 

• With about one in two people with early-stage NSCLC experiencing disease recurrence following surgery, despite adjuvant chemotherapy,1 more effective treatment options are urgently needed to provide the best chance for cure2
• Data are being presented as a late-breaking abstract during the ESMO Asia 2023 Presidential Symposium

This exploratory subanalysis of 140 patients from South Korea, mainland China, Japan, Taiwan, and Thailand confirmed the global ALINA data and showed that Alecensa® (alectinib) reduces the risk of disease recurrence or death by 61% (hazard ratio [HR]=0.39; 95% CI: 0.18-0.85) compared with platinum-based chemotherapy in people with completely resected stage IB (tumour ≥4cm) to IIIA (UICC/AJCC 7th edition) anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).3 A clinically meaningful improvement of central nervous system (CNS)-DFS was also observed (HR=0.24; 95% CI: 0.05-1.12).3 The safety and tolerability of Alecensa in this analysis were consistent with the global ALINA data and previous trials in the metastatic setting and no unexpected safety findings were observed.3 Overall survival data in the Asia subgroup were immature at the time of this analysis.3 

The results of this Asia subanalysis from the ALINA study are being presented as a late-breaking abstract at the European Society of Medical Oncology (ESMO) Asia Congress 2023 Presidential Symposium on Saturday 02 December 2023. 

“In Asia, over a million people a year are diagnosed with NSCLC, and it is likely that half of those will experience recurrence in their disease at some stage. The significant reduction in recurrence and death amongst patients in Asia with ALK-positive early-stage NSCLC shown in the ALINA study, represents real hope for these patients and their loved ones,” said Dr. Ahmed Elhusseiny, Area Head, Asia Pacific, Roche Pharmaceuticals. “The data show that Alecensa has the potential to alter the course of disease, which is why we are committed to working together with stakeholders across Asia, to make this important treatment option available to patients so that they can live better, longer lives.” 

“Alecensa represents a potentially important new treatment option for all patients, including those from Asia, with ALK-positive resected lung cancer,” said Professor Jin Seok Ahn, Medical Oncologist, Samsung Medical Center, Republic of Korea. “In a setting where treatment options are currently extremely limited, the magnitude of the disease-free survival benefit observed in the Asia subgroup of this study has the potential to change the way we manage the disease for people from this region."

It is estimated that over 1 million people in Asia were diagnosed with NSCLC in 2020 with ALK-positive disease accounting for approximately 5% of all cases.4-7 Delaying disease progression is of particular importance for people with ALK-positive NSCLC, who are generally younger – usually around 55 – and are at higher risk of developing brain metastases than those with other types of NSCLC.8 Once the disease returns it often spreads to other parts of the body, at which point it is usually considered incurable.2,9 Comprehensive biomarker testing is essential to helping physicians secure a complete, personalised diagnosis and identify the right treatment for each patient. 

Results from the exploratory subanalysis of ALINA were consistent with results from the primary analysis of the study, recently presented at the ESMO Congress 2023, where consistent DFS results were seen across all subgroups, including disease stage and race (Asian and non-Asian patients).10 Overall, use of Alecensa in the adjuvant setting was tolerable, manageable and in line with its known safety profile in the metastatic setting.1,10 

References 

[1] Pignon JP et al. Lung Adjuvant Cisplatin Evaluation: A Pooled Analysis by the LACE Collaborative Group. J Clin Oncol. 2008;26:3552-3559. 

[2] Hendricks LE et al. Oncogene-addicted metastatic non-small-cell lung cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023;34(4):339-357. 

[3] Ahn JS et al. Efficacy and safety of adjuvant alectinib vs platinum-based chemotherapy (CT) in patients (pts) from Asia with resected, early-stage ALK+ non-small cell lung cancer (NSCLC): a subanalysis of ALINA. Presentation at: European Society for Medical Oncology Asia Congress; 1-3 December 2023. Late-breaking abstract #LBA1. 

[4] The Global Cancer Observatory. Asia Fact Sheet 2020. [Internet; cited November 2023]. Available from: https://gco.iarc.fr/today/data/factsheets/populations/935-asia-fact-sheets.pdf. 

[5] Barlesi et al. Routine molecular profiling of patients with advanced non-small-cell lung cancer: results of a 1-year nationwide programme of the French Cooperative Thoracic Intergroup (IFCT). Lancet. 2016; 387(10026):1415-1426. 

[6] Tian et al. Clinical characteristics and sequence complexity of anaplastic lymphoma kinase gene fusions in Chinese lung cancer patients. Lung Cancer. 2017;114:90-95. 

[7] Cancer.Net®. Lung Cancer - Non-Small Cell: Statistics. [Internet; cited November 2023]. Available from: https://www.cancer.net/cancer-types/lung-cancer-non-small-cell/statistics. 

[8] Griesinger F et al. Brain metastases in ALK-positive NSCLC – time to adjust current treatment algorithms. Oncotarget. 2018:9(80);35181-35194. 

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[9] Peters S et al. Alectinib versus Crizotinib in Untreated ALK-Positive Non–Small-Cell Lung Cancer. NEJM. 2017;377:829-838. 

[10] Solomon B et al. ALINA: efficacy and safety of adjuvant alectinib versus chemotherapy in patients with early-stage ALK+ non-small cell lung cancer (NSCLC). Presentation at: European Society for Medical Oncology Congress; 20-24 October 2023. Late-breaking abstract #LBA2. 

[11] Thandra KC et al. Epidemiology of lung cancer. Contemp Oncol. 2021;21(1):45-52. [12] American Cancer Society: What Is Lung Cancer? [Internet; cited November 2023] Available from: https://www.cancer.org/cancer/non-small-cell-lung-cancer/about/what-is-non-small-cell-lung-cancer.html.