Iruplinalkib (WX-0593) Versus Crizotinib in ALK TKI-Naive Locally Advanced or Metastatic ALK-Positive NSCLC: Interim Analysis of a Randomized, Open-Label, Phase 3 Study (INSPIRE)

J o u r n a l P r e -p r o o f patients in the iruplinalkib group (median PFS, 27.7 months [95% CI, in the crizotinib group; HR, 0.34 [98.02% CI, 0.23-0.52];p<0.0001).The ORR assessed by IRC was 93.0% (95% CI, 87.5-96.6) in the iruplinalkib group and 89.3% (95% CI, 83.1-93.7) in the crizotinib group.The intracranial ORR was 90.9% (10/11, 95% CI, 58.7-99.8) in the iruplinalkib group and 60.0% (9/15, 95% CI, 32.3-83.7) in the crizotinib group for patients with measurable baseline CNS metastases.Incidence of grade 3 or 4 treatment-related adverse events was 51.7% in the iruplinalkib group and 49.7% in the crizotinib group.Interpretation: Iruplinalkib demonstrated significantly improved PFS and improved intracranial antitumor activity versus crizotinib.Iruplinalkib may be a new treatment option for patients with advanced ALK positive and ALK TKI-naïve NSCLC.