ALK rearrangements are present in 4–5% of NSCLC patients, mainly in younger non-smokers, with a heightened risk of brain metastases. It is the preferred first-line treatment for advanced ALK+ NSCLC, supported by three Phase III trials demonstrating superior progression-free survival over crizotinib, strong CNS efficacy, and a well-managed safety profile. Notably, the ALINA trial is the sole positive Phase III trial for an ALK inhibitor in resectable Stage IB–IIIA, ALK+ NSCLC. The trial compares adjuvant alectinib to the standard-of-care chemotherapy. Presently, the company's primary focus is ALINA exploratory sub analysis of patients from Asia presented at ESMO Asia 2023.

The ALINA trial, conducted globally, included 257 participants with resectable ALK+ NSCLC across 26 countries. An exploratory subgroup analysis involved 140 patients from Asian regions. As of the data cut-off on June 26, 2023, 25.4% of patients in the alectinib group were continuing the study treatment. The median follow-up duration was 27.6 months.

In Asian patients with resected Stage IB–IIIA ALK+ NSCLC, adjuvant alectinib demonstrated a 61% reduction in the risk of disease recurrence or death compared to chemotherapy. The benefits of DFS with alectinib were generally consistent across various subgroups. Additionally, in patients with resected stage IB–IIIA ALK+ NSCLC, adjuvant alectinib lowered the risk of CNS recurrence or death by 76% compared to chemotherapy.

The alectinib arm had a median safety follow-up duration of 24.8 months, while the chemotherapy arm had a follow-up duration of 3.7 months. The safety profile of adjuvant alectinib was found to be acceptable, manageable, and consistent with the established characteristics of alectinib.

Conclusion

In Asian patients with resected stage IB–IIIA ALK+ NSCLC, adjuvant alectinib demonstrated a clinically significant enhancement in DFS compared to chemotherapy, accompanied by an improvement in CNS disease-free survival within the Asia subgroup. The tolerability and safety profile of adjuvant alectinib were consistent with known characteristics. These findings align with global data from the ALINA trial, underscoring the importance of routine ALK testing across all NSCLC stages. The results advocate for adjuvant alectinib as a crucial and effective treatment strategy for patients with stage IB–IIIA, ALK+ NSCLC.

Reference reports by DelveInsight for more in-depth analysis and key coverage - 

• Anaplastic lymphoma kinase Non-Small Cell Lung Cancer (ALK-NSCLC) Market Insight, Epidemiology, and Market Forecast
• Non-Small Cell Lung Cancer Market Insight, Epidemiology, and Market Forecast

Note: The therapeutics segment is experiencing significant NSCLC clinical trial activity, which is further expected to drive Non-Small Cell Lung Caner market growth in the coming years.