The efficacy and safety of Yiluake Tablets (Qixinke) in the treatment of lung cancer

Introduction: Yiruake Tablets (Qixinke) is an innovative drug for the treatment of ALK-positive non-small cell lung cancer (NSCLC). It has been approved for marketing by the National Medical Products Administration (NMPA) of China, bringing new hope to the treatment of domestic ALK+ NSCLC patients. In addition, Yiruake tablets have been included in the national medical insurance catalog, which will help reduce patients' medication burden.

Indications

is a highly selective oral anaplastic lymphoma kinase (ALK) and c-ros oncogene 1 (ROS1) tyrosine kinase inhibitor (TKI) developed by Qilu Pharmaceutical Co., Ltd. for the treatment of ALK-positive (ALK+) or ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC). In June 2023, Iluak Tablets was approved in China for the treatment of patients with locally advanced or metastatic ALK+ NSCLC whose disease has progressed after previous crizotinib treatment or who are intolerant to crizotinib.

Efficacy

Iluak Tablets is an ALK/ROS1 tyrosine kinase inhibitor that has shown clinical activity in clinical studies for patients with ALK+ locally advanced or metastatic NSCLC whose disease has progressed after previous treatment with crizotinib. In a phase 3 clinical study, the median progression-free survival (PFS) of the Iluac group was 27.7 months, while that of the crizotinib group was 14.62 months, indicating that the PFS of the Iluak group was significantly improved. Iluac Tablets demonstrated higher objective response rate and intracranial objective response rate compared with crizotinib in the treatment of patients with ALK-positive NSCLC.

Compared with crizotinib, Iluac tablets can significantly improve PFS and improve intracranial anti-tumor activity. Iluac tablets may be a new treatment option for advanced ALK-positive NSCLC patients who have not received ALK TKI treatment.

Safety

In the Phase 3 clinical study, the incidence rates of grade 3/4 adverse events in the Iluac Tablets group and the crizotinib group were 58.7% and 55% respectively. The most common Grade 3/4 adverse event in the Iluac Tablets group was hypertension. The safety profile of Iluak Tablets is consistent with the safety characteristics of previous studies, showing no new safety signals, and does not increase safety risks compared with crizotinib treatment.

Medication Reference

The recommended dose of Yiruake Tablets (Qixinke) for adult patients is 60 mg once a day on days 1-7, and 180 mg once a day starting from the eighth day. It is recommended to take it on an empty stomach in the morning.