Multicenter phase 3 trial of iruplinalkib versus crizotinib for ALK TKI-naïve advanced ALK-positive non-small cell lung cancer

Iruplinalkib (WX-0593) is a new-generation ALK tyrosine kinase inhibitor (TKI). The multicenter phase 3 INSPIRE trial in China compared iruplinalkib versus crizotinib for ALK TKI-naïve locally advanced or metastastic ALK-positive non-small cell lung cancer. Interim analysis, after 26.7 months follow-up in the iruplinalkib group and 25.9 months in the crizotinib group, found median progression-free survival of 27.7 months with iruplinalkib versus 14.6 months with crizotinib (HR 0.34; p<0.0001). The objective response rate was 93.0% with iruplinalkib and 89.3% with crizotinib. The intracranial ORR in patients with baseline CNS metastases was 90.9% with iruplinalkib versus 60.0% with crizotinib. Incidence of grade 3 or 4 treatment-related adverse events was 51.7% in the iruplinalkib group and 49.7% in the crizotinib group. The authors conclude that iruplinalkib may be a new treatment option for patients with ALK TKI-naïve advanced ALK-positive NSCLC.