2024 World Conference on Lung Cancer (WCLC) - Posters-P1.12B.07 Iruplinalkib in Patients with ALK-Positive Crizotinib-Resistant NSCLC: Updated Efficacy and Safety Data from a Phase 2 Trial

P1.12B.07 Iruplinalkib in Patients with ALK-Positive Crizotinib-Resistant NSCLC: Updated Efficacy and Safety Data from a Phase 2 Trial

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The phase 2 INTELLECT trial assessed the efficacy and safety of iruplinalkib in patients with ALK-positive crizotinib-resistant advanced non-small cell lung cancer (NSCLC). This updated report includes two years' additional follow-up data. Iruplinalkib, previously approved for treating ALK-positive NSCLC, had shown improved progression-free survival (PFS) and intracranial anti-tumor activity compared to crizotinib.<br /><br />At the data cutoff on December 29, 2023, 146 patients were involved, with a median follow-up of 42.41 months. The median overall survival (OS) was reported at 41.79 months. Of these patients, 72 (49.3%) died, and 16 (11.0%) were lost to follow-up. The study reported a 63.7% overall response rate (ORR) and a 94.5% disease control rate (DCR) among patients.<br /><br />Regarding intracranial efficacy, in patients with measurable intracranial lesions, the intracranial ORR was 64.3%. For those with CNS metastases, 18.9% achieved complete intracranial response, and the intracranial ORR was 45.6%. The median duration of intracranial response (DoR) was 19.78 months, with a median intracranial PFS of 17.25 months.<br /><br />The trial also evaluated treatment-related adverse events (TRAEs), of which the most common included increased aspartate aminotransferase, hypercholesterolemia, and hypertriglyceridemia. Grade 3 or 4 TRAEs occurred in 30.8% of patients, with 1.4% fatalities related to TRAEs. Iruplinalkib demonstrated a sustained OS benefit with no new safety concerns emerging over the extended follow-up period.<br /><br />Overall, iruplinalkib provided considerable intracranial and systemic efficacy in this patient population, representing a viable treatment option for crizotinib-resistant ALK-positive NSCLC.

Asset Subtitle

Yuankai Shi

Meta Tag

Speaker Yuankai Shi

Topic Metastatic NSCLC – Targeted Therapy

Keywords

INTELLECT trial

iruplinalkib

ALK-positive

crizotinib-resistant

NSCLC

progression-free survival

intracranial response

adverse events

overall survival

disease control rate