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Iruplinalkib, a novel ALK inhibitor, is more effective than crizotinib for patients with advanced, ALK-positive non-small cell lung cancer (NSCLC), results from the INSPIRE trial suggest.
Patients who received iruplinalkib in this phase 3 trial had a higher objective response rate (ORR) and longer progression-free survival (PFS) than patients who received crizotinib. Iruplinalkib also demonstrated greater efficacy in patients with central nervous system (CNS) metastasis.
These results were presented at the 2023 World Conference on Lung Cancer by Runxiang Yang, MD, of Yunnan Cancer Hospital in Kunming, China.
The INSPIRE trial (ClinicalTrials.gov Identifier: NCT04632758) included 292 patients with ALK-positive, stage IIIB/IV NSCLC who had received no prior treatment with an ALK tyrosine kinase inhibitor (TKI).
The patients were randomly assigned to receive iruplinalkib (n=143) or crizotinib (n=149). Patients received iruplinalkib at 180 mg daily, with a 7-day lead-in at 60 mg daily. Patients received crizotinib at 250 mg twice a day.
Baseline characteristics were generally well balanced between the arms. The median age was 55 years in both arms (overall range, 25-76). All patients were Asian, most had stage IV disease (89.5% in the iruplinalkib arm and 94.6% in the crizotinib arm), a minority had CNS metastasis (25.9% and 29.5%, respectively), and 16.8% in both arms had received prior chemotherapy.
At the interim analysis, the median follow-up for PFS was 23.98 months for the iruplinalkib arm and 24.54 months for the crizotinib arm. The median treatment duration was 23.92 months and 12.94 months, respectively.
Per independent review, the median PFS was 27.70 months in the iruplinalkib arm and 14.62 months in the crizotinib arm (hazard ratio [HR], 0.344; 95% CI, 0.226-0.523; P <.0001).
Among patients with CNS metastasis at baseline, the median PFS was 21.95 months in the iruplinalkib arm and 11.1 months in the crizotinib arm (HR, 0.242; 95% CI, 0.119-0.493; P <.0001). Among patients without CNS metastasis at baseline, the median PFS was 28.32 months in the iruplinalkib arm and 16.46 months in the crizotinib arm (HR, 0.360; 95% CI, 0.236-0.548; P <.0001).
In the overall cohort, the ORR was 93% in the iruplinalkib arm and 89.3% in the crizotinib arm. The median duration of response was 26.78 months and 12.88 months, respectively (HR, 0.312; 95% CI, 0.215-0.452; P <.0001).
The intracranial ORR was 90.9% in the iruplinalkib arm and 60.0% in the crizotinib arm. The median duration of intracranial response was 20.14 months and 9.26 months, respectively.
Treatment-related adverse events (TRAEs) occurred in 98.6% of patients in the iruplinalkib arm and 99.3% of those in the crizotinib arm. The most common TRAEs in both arms were aspartate aminotransferase increase, blood creatine phosphokinase increase, and alanine transaminase increase.
The rate of grade 3-4 TRAEs was 51.7% in the iruplinalkib arm and 49.7% in the crizotinib arm. The rate of serious TRAEs was 14.0% and 10.7%, respectively. There were no fatal TRAEs in the iruplinalkib arm, but there were 2 in the crizotinib arm.
“Iruplinalkib may be a new treatment option for patients with advanced, ALK-positive and ALK TKI-naive non-small cell lung cancer,” Dr Yang said.
Disclosures: This research was supported by Qilu Pharmaceutical Co., Ltd. No other disclosures were provided.
Reference
Shi Y, Chen J, Yang R, et al. Randomized, phase 3 study of iruplinalkib (WX-0593) vs crizotinib in locally advanced or metastatic ALK+ non-small cell lung cancer (NSCLC). Presented at WCLC 2023. September 9-12, 2023. Abstract OA03.05A.
This article originally appeared on Cancer Therapy Advisor
