Qilu Pharmaceutical's Iruplinalkib (WX-0593) INSPIRE Phase III Study Published in Journal of Thoracic Oncology

Jinan, January 30, 2024 /PRNewswire/ -- Recently, the interim analysis results of the Phase III INSPIRE study on Qilu Pharmaceutical's Irulast® tablets for first-line treatment of locally advanced or metastatic anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer were published in the official journal of the International Association for the Study of Lung Cancer, the "Journal of Thoracic Oncology" (IF=20.4). The publication of the Irulast® INSPIRE study results in this prestigious international journal reflects the high recognition by the global academic community of the clinical significance of this research and further enhances academic awareness of both the INSPIRE study and Irulast®.

Iruac is a new generation of ALK receptor tyrosine kinase inhibitor (TKI), which inhibits both wild-type and mutant ALK fusion genes. This study was conducted across 40 centers in China, led by Professor Shi Yuankai from the Cancer Hospital of the Chinese Academy of Medical Sciences. The results showed that, compared with the control group, Iruac significantly prolonged progression-free survival (PFS) and demonstrated superior intracranial antitumor activity.

INSPIRE is a randomized, open-label, multicenter Phase III clinical trial designed to evaluate the efficacy and safety of Iruplak versus Crizotinib in patients with ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received ALK inhibitor treatment. Some data were previously presented as an oral report at the 2023 World Conference on Lung Cancer.

From September 4, 2019, to December 2, 2020, the study enrolled a total of 292 patients with ALK-positive locally advanced or metastatic NSCLC, including 81 patients with central nervous system (CNS) metastases.

Based on the results published in the Journal of Thoracic Oncology, as of November 13, 2022, the IRC-assessed results showed that the median PFS for the Iruac group and the Crizotinib group were 27.7 months and 14.6 months, respectively, with a hazard ratio (HR) of 0.34 (98.02% Confidence Interval CI, 0.23-0.52). Compared with the Crizotinib group, the risk of disease progression or death in the Iruac group was reduced by 66%. The PFS results assessed by the investigators were consistent with the IRC assessment. As of the data cutoff, the median follow-up time for OS in the Iruac group was 26.7 months, and the median follow-up time in the control group was 25.9 months. The median OS has not yet been reached.

Subgroup analysis and other secondary endpoints also support the superior efficacy of Iruplak. The tumor response with Iruplak was more durable compared to the control group (median DoR, 26.8 months vs. 12.9 months; HR, 0.31). In patients with baseline CNS metastases, the CNS objective response rate was higher in the Iruplak group (intracranial ORR, 57.9% vs. 25.6%; intracranial CR, 31.6% vs. 2.6%); in patients with measurable baseline CNS metastatic lesions, the intracranial ORR in the Iruplak group reached 90.9%.

In terms of safety, although patients in the Irulak group were treated for a longer duration than those in the control group (23.9 months vs. 12.9 months), the incidence rates of severe adverse reactions (Grade 3 or 4) were comparable between the two groups (51.7% vs. 49.7%).

Based on the results of the INSPIRE study, Iruac was approved by the National Medical Products Administration in January this year for monotherapy in patients with ALK-positive locally advanced or metastatic NSCLC. Long-term follow-up of this study is still ongoing, and new data will be gradually disclosed at various academic conferences.

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