QiLu Pharmaceutical's Iruplinalkib Phase III INSPIRE Study Researched Primary Endpoint and was Selected for 2023 WCLC Oral Presentation

JINAN, China, Aug. 17, 2023 /PRNewswire/ — August 16, 2023, at the 2023 World Conference on Lung Cancer (WCLC), the complete list of selected abstracts was announced, among which QiLu Pharmaceutical’s iruplinalkib phase III clinical trial (INSPIRE) results were chosen for oral presentation at the conference.

The iruplinalkib INSPIRE study is a randomized, open, multi-center phase III clinical trial, designed to evaluate the efficacy and safety of Iruplinalkib (oral 180 mg, once daily; 60 mg once daily for the 7-day lead-in phase) versus crizotinib (oral 250 mg, twice daily) in patients with ALK-positive advanced non-small cell lung cancer (NSCLC) who have not previously received ALK TKI treatment. The primary endpoint is progression-free survival (PFS), as assessed by an Independent Review Committee (IRC). The leading investigator of the study is Professor Yuankai Shi from the Cancer Hospital Chinese Academy of Medical Sciences. The study was carried out across 40 hospitals in China.

Between September 4, 2019, and December 2, 2020, a total of 292 patients were enrolled and randomized to treatment (iruplinalkib group 143; crizotinib group 149). The published results were based on an interim analysis of the study, reviewed by the Independent Data Monitoring Committee (IDMC) (data cut-off date: November 13, 2022). The median follow-up time for the iruplinalkib and crizotinib groups was 23.98 months and 24.54 months, respectively. The results showed that the primary endpoint PFS (per RECIST v1.1 by IRC) met the pre-defined criteria, and the PFS in iruplinalkib group was significantly improved 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 such as duration of response (DoR) and control of intracranial disease, the results in iruplinalkib group were also superior to those from the crizotinib group. In this study, the safety of Iruplinalkib was consistent with the safety profile of previous studies. Iruplinalkib showed a good safety profile and no increased safety risk compared to crizotinib.

On June 28, 2023, the China National Medical Products Administration approved iruplinalkib tablets for market launch, for the treatment of patients with locally advanced or metastatic ALK-positive NSCLC who have progressed or are intolerant to crizotinib. Currently, the new drug application for iruplinalkib as a first-line treatment for ALK-positive, advanced NSCLC patients has been submitted and accepted by China CDE. Iruplinalkib may be a new treatment option for patients.

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