Efficacy and safety of iruplinalkib (WX­0593) on non­small cell lung cancer with SPECC1L­ALK fusion: A case report.

ABSTRACT

The evidence of anaplastic lymphoma kinase (ALK) inhibitor for non-small cell lung cancer (NSCLC) harbouring sperm antigen with calponin homology and coiled-coil domains 1-like (SPECC1L)-ALK fusion was limited. In a previous case report, a Chinese, 44-year-old, female non-smoker with stage IV NSCLC harbouring SPECC1L-ALK fusion was treated with crizotinib ± bevacizumab for 23 months (from October 2017 to September 2019) and second-generation ALK inhibitor iruplinalkib for 2.5 months (from October 2019 to January 2020). The present study is an updated case report of subsequent follow-up of this patient. The patient participated in the phase II INTELLECT study and received iruplinalkib 180 mg once daily with a 7-day lead-in phase at 60 mg once daily. Systemic partial response was achieved 1 month later. Intracranial complete response was achieved nearly 5 months after iruplinalkib treatment initiation. Systemic and intracranial responses continued as of cut-off date (February 2023). The progression-free survival reached 39.3 months, with right censoring (progression did not occur during follow-up). Grade 3 hypertriglyceridaemia complicated with grade 2 hypercholesterolaemia recovered after fenofibrate treatment. The other adverse events were not noteworthy. Iruplinalkib demonstrated promising systemic and intracranial efficacy for NSCLC harbouring SPECC1L-ALK gene, with acceptable and manageable adverse events (for example, grade 3 hypertriglyceridaemia or grade 2 hypercholesterolaemia). Iruplinalkib may be an ideal option for patients with rare ALK fusions.