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Gregory J. Riely, MD, PhD


Phase III INSPIRE Trial: Iruplinalkib vs Crizotinib in Metastatic ALK-Positive NSCLC

By: Joshua D. Madera, MD
Posted: Monday, April 1, 2024

For patients with ALK-positive non–small cell lung cancer (NSCLC), the use of the investigational ALK tyrosine kinase inhibitor iruplinalkib may prove to be a future therapeutic alternative to the older tyrosine kinase inhibitor crizotinib, according to the results of the phase III INSPIRE trial, published in the Journal of Thoracic Oncology. Treatment with iruplinalkib improved progression-free survival and intracranial antitumor activity compared with crizotinib, making it a potential management strategy in patients with both ALK-positive and ALK tyrosine kinase inhibitor–naive NSCLC, explained Yuankai Shi, MD, of the Chinese Academy of Medical Sciences & Peking Union Medical College, and colleagues.

“Compared with crizotinib, iruplinalkib reduced the risk of disease progression or death by 66% (hazard ratio = 0.34; P < .0001). Results from the investigator-assessed primary endpoint were consistent with independent review committee–assessed results,” the investigators reported.

From 2019 to 2020, a total of 292 patients with ALK-positive NSCLC were recruited for the study. Patients were randomly assigned to receive treatment with either crizotinib (n = 149) or iruplinalkib (n = 143). They were monitored regularly by an independent review committee to assess their clinical outcomes and to quantify treatment-related adverse events.

The study authors reported a significantly increased progression-free survival with iruplinalkib (27.7 months) compared with crizotinib (14.6 months, hazard ratio = 0.34). The objective response rates were 93.0% and 89.3% with iruplinalkib and crizotinib, respectively. Furthermore, for patients with measurable central nervous system metastases, the intracranial objective response rates for those treated with iruplinalkib and crizotinib were 90.9% and 60.0%, respectively. Moreover, the rate of treatment-related adverse events was similar in patients treated with iruplinalkib (51.7%) and crizotinib (49.7%).

Disclosure: For full disclosures of the study authors, visit

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