Iruplinalkib

JINAN, China, Jan. 30, 2024 /PRNewswire/ -- The interim analysis results from the phase III INSPIRE study of iruplinalkib developed by Qilu Pharmaceutical, which focuses on the first-line treatment of locally advanced or metastatic anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), have recently been featured in the Journal of Thoracic Oncology (Impact Factor=20.4), the official journal of the International Association for the Study of Lung Cancer (IASLC). The publication of the findings in the prestigious international journal underscores the global academic community's strong recognition of the clinical value of these results, while significantly enhancing the community's comprehension of the INSPIRE study and iruplinalkib. Iruplinalkib is a next-generation ALK receptor tyrosine kinase inhibitor (TKI) that effectively targets both the wild-type and mutant ALK fusion genes. The study, conducted at 40 centers throughout China and led by Prof. Shi Yuankai from the Cancer Hospital of Chinese Academy of Medical Sciences, showed that iruplinalkib significantly extended progression-free survival (PFS) and demonstrated enhanced intracranial anti-tumor activity relative to the control group. The INSPIRE study, a randomized, open-label, multicenter Phase III clinical trial compared the efficacy and safety of iruplinalkib against crizotinib in locally advanced or metastatic ALK-positive NSCLC patients who had not previously been treated with an ALK inhibitor. Key findings were presented at the 2023 World Conference on Lung Cancer. Between September 4, 2019 and December 2, 2020, the trial enrolled 292 patients diagnosed with locally advanced or metastatic ALK-positive NSCLC, including 81 with central nervous system (CNS) metastases. The results of the INSPIRE study, as published in the Journal of Thoracic Oncology and assessed by the Independent Review Committee (IRC) as of November 13, 2022, indicate that the median PFS was significantly longer in the iruplinalkib group (27.7 months) compared to the crizotinib group (14.6 months), with a hazard ratio (HR) of 0.34 (98.02% CI: 0.23-0.52), demonstrating a 66% reduction in disease progression or death risk. The PFS outcomes assessed by investigators were consistent with those determined by the IRC. As of the data cut-off, the median follow-up time for overall survival (OS) was 26.7 months for the iruplinalkib group and 25.9 months for the control group. The median OS had not yet been reached. Subgroup analyses and additional secondary endpoints further supported iruplinalkib's superior efficacy. Iruplinalkib led to longer duration of tumor response compared to the control group (median duration of response: 26.8 months versus 12.9 months; HR: 0.31). In patients with CNS metastases at baseline, the iruplinalkib group exhibited a higher intracranial objective response rate (ORR). The intracranial ORR was 57.9% in the iruplinalkib group versus 25.6% in the control group The intracranial complete response (CR) rate was 31.6% compared to 2.6% in the control group. Furthermore, among those with measurable CNS metastases at baseline, the intracranial ORR for the iruplinalkib group reached 90.9%. In terms of safety, although patients in the iruplinalkib group underwent treatment for a longer duration than those in the control group (23.9 months versus 12.9 months), the frequency of severe adverse reactions (grade 3 or 4) was comparable between the two groups, with 51.7% in the iruplinalkib group versus 49.7% in the control group. Following the positive outcomes of the INSPIRE study, iruplinalkib was approved by the China National Medical Products Administration (NMPA) in January of this year for use as a single-agent therapy in treating locally advanced or metastatic ALK-positive NSCLC. Longer follow-up of the study is in progress. Updated results will be presented at upcoming academic conferences. Link to the article: (24)00033-9/fulltext SOURCE Qilu Pharmaceutical Co., Ltd.

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. SOURCE Qilu Pharmaceutical Co., Ltd.