Results of the Phase III INSPIRE Study on Qilu Pharmaceutical's Iruplinalkib Published in the Journal of Thoracic Oncology

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. The INSPIRE study, a randomized, open-label, multicenter Phase III clinical trial compared the efficacy and safety of iruplinalkib against crizotinib in...

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: https://www.jto.org/article/S1556-0864(24)00033-9/fulltext

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