Qilu Pharmaceutical's Iruplinalkib (Qixinke®) Phase III INSPIRE Study Meets Primary Endpoint and Selected for Oral Presentation at 2023 World Conference on Lung Cancer

JinanAugust 17, 2023PR Newswire -- August 16, 2023, the 2023 World Conference on Lung Cancer (WCLC) announced all selected abstracts, among which the results of Qilu Pharmaceutical's Phase III clinical study (INSPIRE) of Yiluak were selected for oral presentation at this conference.

The INSPIRE Study of Iruac is a randomized, open-label, multicenter Phase III clinical trial designed to evaluate the efficacy and safety of Iruac (orally administered at 180 mg once daily; 60 mg once daily during the initial 7-day lead-in period) compared with Crizotinib (orally administered at 250 mg twice daily) in ALK-positive advanced non-small cell lung cancer (NSCLC) patients who have not previously received ALK TKI treatment. The primary endpoint is progression-free survival (PFS) assessed by an Independent Review Committee (IRC). The principal investigator of this study is Professor Shiyuankai from the Cancer Hospital of the Chinese Academy of Medical Sciences, and the research is being conducted across 40 hospitals in China.

Between September 4, 2019, and December 2, 2020, a total of 292 patients were enrolled and received treatment (143 in the IruAlk group; 149 in the Crizotinib group). The results published this time are based on the interim analysis reviewed by the Independent Data Monitoring Committee (IDMC) (data cutoff date for interim analysis: November 13, 2022). The median follow-up times for the IruAlk group and the Crizotinib group were 23.98 months and 24.54 months, respectively. The results showed that the primary endpoint, PFS (assessed by IRC based on RECIST v1.1), met the pre-specified criteria. The PFS was significantly improved in the IruAlk group compared to the Crizotinib group, with median PFS of 27.70 months and 14.62 months, respectively (hazard ratio, 0.344 [98.02% confidence interval 0.226-0.523]). In terms of secondary endpoints, including Duration of Response (DoR) and intracranial disease control, the IruAlk group also demonstrated significant superiority over the Crizotinib group. In this study, the safety profile of IruAlk was consistent with its safety characteristics observed in previous studies, showing good safety without increasing safety risks compared to Crizotinib treatment.

On June 28 this year, the National Medical Products Administration approved Irulac tablets (trade name: Qixinke).^®) has been approved for marketing in China, indicated for the treatment of patients with locally advanced or metastatic ALK-positive NSCLC who have experienced disease progression after prior crizotinib treatment or are intolerant to crizotinib. Currently, the new drug application for iruplakib as a first-line treatment for ALK-positive, advanced NSCLC patients has been submitted and accepted by the CDE. Iruplakib is expected to provide a new treatment option for patients.