CLINICAL EVIDENCE

Dynamics of EGFR Mutational Load in Urine and Plasma Correlates with Treatment Response in Advanced NSCLC

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EGFR Mutational Load in Urine and Plasma Correlates with Treatment Response in Advanced NSCLC

Introduction

  • Non-small cell lung cancer (NSCLC) is a heterogeneous and dynamic disease where testing for key mutations is essential.
  • With the emergence of clonal resistance, obtaining serial biopsies to assist in the real-time treatment decision-making has proven challenging.
  • Noninvasive urinary circulating tumor (ct) DNA-based liquid biopsy approach can be used to detect and track cancer driver mutations for rapid diagnosis and disease monitoring.
  • Here, using a highly sensitive ctDNA mutation detection platform, we demonstrate detection of EGFR mutations in urine and plasma samples obtained from patients with NSCLC.

Clinical Study Design

  • This is a prospective observational study of patients with non-squamous, tissue-confirmed EGFR, KRAS or ALK-mutant NSCLC preparing to receive a systemic treatment regimen.
  • The primary endpoints are correlation between ctDNA and tumor-based molecular results, and measurable change in ctDNA with response by RECIST v1.1.
  • Urine and blood specimens are collected from patients at baseline, on treatment, and at progression for ctDNA analyses.
  • This study has enrolled 34 patients, and presented here is an interim analysis of 20 NSCLC patients with EGFR-positive tumors.

Highlighted Tables and Graphs

Clinical Study Design

EGFR Clinical Evidence Chart 1

Longitudinal Monitoring of ctDNA EGFR in Non-Responders

EGFR Clinical Evidence Chart 3

Conclusions

  • Mutation enrichment NGS testing by urine and plasma ctDNA correctly identified EGFR activating mutations in 85% of patients.
  • Monitoring EGFR levels in urine/plasma enabled accurate assessment of response in advance of radiographic evaluation and regardless of therapy type in 100% of patients, with a cut-off of 90% decrease in EGFR load, discriminating between patients with disease control (PR or SD) and patients with disease progression (PD).
  • Analysis of urine and plasma for EGFR mutations may be a viable approach for therapeutic monitoring of patients with advanced cancers.
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