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Lorlatinib Demonstrates Efficacy, Safety for Patients With ALK-Positive Non-Small Cell Lung Cancer

According to final results from a phase 2 study, lorlatinib, a third-generation anaplastic lymphoma kinase (ALK) and ROS1 tyrosine kinase inhibitor (TKI), demonstrated efficacy and safety among patients with both treatment-naive and previously-treated ALK-positive non-small cell lung cancer (NSCLC). 

In this study, researchers enrolled patients who were treatment naive (n = 30) or had experienced disease progression following crizotinib with or without chemotherapy (n = 59), following 1 second-generation ALK TKI with or without chemotherapy (n = 28), following ≥ 2 ALK TKI with or without chemotherapy (n = 111), or following ≥ 1 ALK TKI with or without chemotherapy (n = 139). Patients received 100 mg of once daily lorlatinib in continuous 21-day cycles. Primary end points included overall survival (OS) and safety. 

After a median follow-up of 5 years, the median OS was not achieved among either treatment-naive patients or those who experienced disease progression following crizotinib. The median OS was 37.4 months for patients who experienced disease progression following 1 second-generation ALK TKI, 19.2 months among patients for experienced disease progression following ≥2 ALK TKI, and 20.7 months for patients who experienced disease progression following ≥1 ALK TKI. 

Dose reductions due to all-cause adverse events were reported by 28% of patients. Temporary treatment discontinuation occurred among 57% of patients and permanent treatment discontinuation occurred among 13% of patients. 

As study authors concluded, these results “confirmed substantial activity, prolonged OS, and generally consistent safety findings with lorlatinib in treatment-naïve and previously treated patients with ALK-positive NSCLC.”


Source: 

Ou SHI, Solomon BJ, Besse B, et al. Brief Report: Final overall survival and long-term safety of lorlatinib in patients with ALK-positive non-small cell lung cancer from the pivotal phase 2 study. J Thorac Oncol. Published online: November 22, 2024. doi: 10.1016/j.jtho.2024.11.021