Application of Yiluake Tablets (Qixinke) in the treatment of ALK-positive lung cancer

Introduction: Yiruake Tablets (Qixinke) is a new oral ALK/ROS1 inhibitor independently developed by Qilu Pharmaceutical for the treatment of ALK-positive non-small cell lung cancer. Yiruake tablets have been approved by the National Medical Products Administration (NMPA) of China for the first-line treatment of patients with ALK-positive NSCLC. The launch of Yiruake Tablets provides a new treatment option for domestic patients with ALK-positive NSCLC, and as a domestic drug, it helps reduce the cost of medication for patients.

Application in the treatment of ALK-positive lung cancer

is a new generation of potent ALK TKI that can effectively target wild-type and mutant ALK fusion genes. Preclinical studies have found that it has inhibitory effects on wild-type ALK and mutant ALK (including ALK L1196M and ALK C1156Y). Iruak tablets were found to have encouraging anti-tumor activity as first-line treatment in patients with ALK-positive NSCLC and exceeded or equaled that of previous treatments in phase 1 studies.

Efficacy study data for the treatment of ALK-positive lung cancer

In an open-label, randomized, multi-center, phase 3 study, 292 patients with ALK-positive non-small cell lung cancer were randomly assigned to receive Iluac tablets 180 mg once daily (n=143) or crizotinib 250 mg twice daily (n=149). The median follow-up time was 26.7 months in the Iluac tablets group and 25.9 months in the crizotinib group. The IRC-assessed PFS of patients in the Iluac tablets group was significantly longer, with the median PFS in the Iluac tablets group being 27.7 months compared with 14.6 months in the crizotinib group.

The ORR assessed by IRC was 93% in the Iluac tablets group and 89.3% in the crizotinib group. For patients with measurable central nervous system metastases at baseline, the intracranial ORR was 90.9% in the Iluac tablets group and 60% in the crizotinib group. The incidence of grade 3 or 4 treatment-related adverse events was 51.7% in the ilunakib group and 49.7% in the crizotinib group.

Notes

1. No dose adjustment is required for patients with mild liver damage, mild renal damage, and elderly patients aged 65 and above.

2. It is prohibited for patients who are allergic to Iluac or any excipients.

3. The patient's liver function, blood lipid levels and blood pressure should be monitored during medication and managed if necessary.

4. The effect of Yiluak Tablets on pregnant women has not been determined, so its use during pregnancy is not recommended unless the potential benefits outweigh the potential risks to the fetus.