Efficacy and safety of iruplinalkib (WX‑0593) on non‑small cell lung cancer with SPECC1L‑ALK fusion: A case report

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.