On January 30, 2024 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), reported to 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) (Press release, Qilu Pharmaceutical, JAN 30, 2024, View Source [SID1234639724]). 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.

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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.