Remarkable tumor response to Iruplinalkib in a 14-year-old girl with ALK-positive advanced metastatic non-small-cell lung cancer: a case report

Abstract

Targeted therapies for anaplastic lymphoma kinase (ALK) mutations in non-small cell lung cancer (NSCLC) generally extend survival and alleviate symptoms. However, significant tumor reduction or complete remission remains rare. We report a rare case of a 14-year-old girl, whose father and grandfather both had lung cancer, diagnosed with advanced, multi-site metastatic ALK-positive NSCLC. She was treated with Iruplinalkib, a newly approved targeted therapy in China, resulting in remarkable tumor shrinkage. The patient presented with severe symptoms, including persistent cough, pain, and hemoptysis. A lung CT scan revealed a large mass, which was pathologically diagnosed as pulmonary adenocarcinoma. After initiating Iruplinalkib therapy, the primary tumor rapidly decreased in size by 80.3%, from 132 mm × 97 mm to 26 mm × 21 mm, within one month. Most metastatic lesions also showed significant regression. By six months, the pulmonary tumor had almost disappeared. This case underscores the potential of Iruplinalkib, which is currently not available outside of China, to induce rapid and profound tumor regression in ALK-positive NSCLC, particularly in adolescent patients with aggressive clinical presentations. We hope that the anticancer efficacy of Iruplinalkib will be recognized globally and that it will become accessible to ALK-positive lung cancer patients worldwide.

Keywords: ALK fusion gene mutation; Iruplinalkib; case report; non-small cell lung cancer; targeted therapy.

Figure 1

Graphic summary of the case.

Figure 2

The pathology and immunohistochemistry of the mass in the right lower lobe. Hematoxylin and eosin (HE) staining revealed that the tumor cells were arranged in acinar, nest-like, and solid patterns. Intracytoplasmic mucin was observed in the tumor cells, with focal areas suggesting the presence of signet-ring-like cells. Immunohistochemical analysis showed diffuse positivity for TTF-1, CK7, and Napsin A, indicating a pulmonary origin. The absence of P40 expression excluded squamous cell carcinoma. Based on these findings, the tumor was considered to be a pulmonary adenocarcinoma. (Immunohistochemical staining was performed using the Ventana Medical Systems platform; detailed protocols are provided in the Supplementary Materials .).