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Updated: Jun 14, 2026

Multiplexed Immunofluorescence Analysis and Quantification of Intratumoral PD-1+ Tim-3+ CD8+ T Cells

Multiplexed Immunofluorescence Analysis and Quantification of Intratumoral PD-1+ Tim-3+ CD8+ T Cells

Published on: February 8, 2018

Noninvasive Early Identification of Therapeutic Benefit from Immune Checkpoint Inhibition.

Barzin Y Nabet¹, Mohammad S Esfahani², Everett J Moding¹

¹Department of Radiation Oncology, Stanford University, Stanford, CA, USA; Stanford Cancer Institute, Stanford University, Stanford, CA, USA.

|October 2, 2020

Summary

This summary is machine-generated.

Predicting durable clinical benefit in non-small cell lung cancer (NSCLC) patients treated with immune checkpoint inhibitors (ICIs) is challenging. A new noninvasive assay integrating circulating tumor DNA (ctDNA) and immune cell profiling accurately forecasts patient outcomes early.

Keywords:

circulating tumor DNA immune checkpoint inhibition immunotherapy liquid biopsy non-small cell lung cancer response classification

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Last Updated: Jun 14, 2026

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Published on: February 8, 2018

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Predictive Immune Modeling of Solid Tumors

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Published on: February 25, 2020

Area of Science:

Oncology
Immunotherapy
Molecular Diagnostics

Background:

Immune checkpoint inhibitors (ICIs) offer durable responses in non-small cell lung cancer (NSCLC), but most patients experience early progression.
Conventional imaging lacks accuracy in predicting durable clinical benefit (DCB) from ICIs.
Identifying patients likely to benefit from ICIs remains a critical unmet need.

Purpose of the Study:

To identify noninvasive biomarkers for predicting durable clinical benefit (DCB) in NSCLC patients receiving ICIs.
To develop and validate a multiparameter assay for early and accurate outcome prediction.

Main Methods:

Analysis of pre-treatment circulating tumor DNA (ctDNA) and peripheral CD8 T cell levels.
Monitoring ctDNA dynamics after the first ICI infusion.
Development and validation of the noninvasive DIREct-On assay integrating these biomarkers.

Main Results:

Pre-treatment ctDNA and CD8 T cell levels were independently associated with DCB.
ctDNA dynamics post-infusion further aided in identifying patients with DCB.
The integrated DIREct-On assay demonstrated higher accuracy in predicting DCB than individual markers.

Conclusions:

Integrated ctDNA and immune cell profiling provide accurate, noninvasive, and early prediction of outcomes for NSCLC patients on ICIs.
The DIREct-On assay offers a promising tool for optimizing immunotherapy selection and management in NSCLC.
This approach may improve treatment strategies by enabling early identification of patients likely to achieve durable responses.