Iruplinalkib Shows Sustained Benefit in Crizotinib-Resistant NSCLC
核心洞察
Updated data from the Phase II INTELLECT study reveals that iruplinalkib demonstrates a median overall survival of 41.79 months in NSCLC (搜索) patients.
The study reported an objective response rate of 63.7% and a disease control rate of 94.5% with iruplinalkib in crizotinib-resistant NSCLC (搜索).
Iruplinalkib showed promising intracranial activity in patients with CNS metastasis, with an intracranial objective response rate of 64.3%.
Updated findings from the Phase II INTELLECT study, presented at the World Conference on Lung Cancer (WCLC) 2024, demonstrate the sustained efficacy and safety of Qilu Pharmaceutical (搜索)'s iruplinalkib tablets (Qixinke®) in treating patients with anaplastic lymphoma kinase (ALK (搜索))-positive crizotinib-resistant non-small-cell lung cancer (搜索) (NSCLC (搜索)). The study's highlights were presented in a poster at the conference held in San Diego, California.
Iruplinalkib, a next-generation ALK (搜索)/ROS1 (搜索) kinase inhibitor, received approval from the NMPA in June 2023 for ALK-positive locally advanced or metastatic NSCLC (搜索) patients who progressed on or were intolerant to crizotinib. It was further approved in January 2024 for first-line treatment of ALK-positive NSCLC.
INTELLECT Study: Efficacy and Safety Results
The INTELLECT study, led by Prof. Yuankai Shi, enrolled 146 subjects. As of December 29, 2023, with a median follow-up of 42.41 months, the study revealed a median overall survival (OS) of 41.79 months. The investigator-evaluated objective response rate (ORR) was 63.7%, and the disease control rate (DCR) reached 94.5%. The median duration of response (DoR) was 14.06 months, and the median progression-free survival (PFS) was 14.55 months.
Activity in CNS Metastasis
In a subgroup of 90 patients with CNS metastasis at baseline, the ORR was 55.6%, and the DCR was 93.3%, according to RECIST v1.1 criteria. The median DoR and median PFS were 17.25 months, and the median OS was 43.01 months.
Based on RANO-BM criteria, intracranial complete response (CR) was achieved in 17 (18.9%) of the 90 patients with CNS metastasis at baseline. Among the 42 subjects with measurable intracranial lesions at baseline, the intracranial objective response rate (iORR) was 64.3%, while the intracranial disease control rate (iDCR) reached 95.2%.
Safety Profile
The safety profile showed a 93.8% incidence of treatment-related adverse events (TRAEs), with 30.8% being grade 3 or 4. The most common TRAEs included elevated aspartate aminotransferase (45.2%), hypercholesterolemia (37.7%), and increased alanine aminotransferase (37.0%). No new safety signals were identified during the extended follow-up.
The long-term follow-up results confirm that iruplinalkib provides a significant OS benefit with a consistent safety profile in patients with ALK (搜索)-positive crizotinib-resistant advanced NSCLC (搜索).