2023 World Conference on Lung Cancer (Posters)-P2.10. Liquid Biopsy-based Umbrella Trial for Advanced NSCLC: Results of Phase 2 Plasma ALK-positive Cohort (A-Liquid)

P2.10. Liquid Biopsy-based Umbrella Trial for Advanced NSCLC: Results of Phase 2 Plasma ALK-positive Cohort (A-Liquid) - PDF(Slides)

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Researchers conducted a phase 2 umbrella trial, called A-Liquid, to evaluate the clinical utility of liquid biopsy-based next-generation sequencing (Liquid NGS) in identifying actionable genomic alterations in patients with non-small cell lung carcinoma (NSCLC). The trial focused on NSCLC patients with oncogene alterations detected by Liquid NGS. The primary endpoint of the study was the objective response rate (ORR) assessed by independent radiology review (IRR), with secondary endpoints including progression-free survival (PFS), duration of response (DoR), and overall survival (OS).<br /><br />The study included 25 patients with ALK fusion-positive NSCLC who were naive to ALK tyrosine kinase inhibitors (TKIs) and had an ECOG performance status of 0-2. These patients were treated with alectinib, a targeted therapy for ALK-rearranged NSCLC. The ORR assessed by IRR was 100%, with a median PFS of 24.7 months and a median OS that was not reached. The 12-month PFS and OS rates were 73.9% and 96.0%, respectively.<br /><br />The study also compared the concordance between Liquid NGS and tissue-based assays. The concordance rate for ALK fusion detection was 77% when compared to gene tests in clinical practice. The most frequently observed targetable gene alterations were EGFR mutation, ALK fusion, KRAS G12C, MET ex14 skip, RET fusion, ROS1 fusion, HER2 ex20ins, and BRAF V600E.<br /><br />In terms of safety, alectinib was well-tolerated, with no new safety concerns identified. The most common treatment-related adverse events were constipation, dysgeusia, peripheral edema, and increased blood bilirubin.<br /><br />In summary, alectinib demonstrated remarkable efficacy in patients with ALK fusion-positive NSCLC detected by both liquid biopsy and tissue-based assays. Liquid NGS remains challenging for detecting fusion genes, highlighting the need for further advancements in precision medicine. Overall, these findings support the use of liquid biopsy-based approaches in identifying actionable genomic alterations in NSCLC.

Asset Subtitle

Yuki Nakatani

Meta Tag

Speaker Yuki Nakatani

Topic Metastatic NSCLC: Targeted Therapy - FUSIONS

Keywords

liquid biopsy-based next-generation sequencing

non-small cell lung carcinoma

ALK fusion-positive NSCLC

alectinib

progression-free survival

overall survival

gene alterations

tissue-based assays

precision medicine

efficacy