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Research Square 2025 Preprint

Combined CTLA-4/CD80 and PD-1/PD-L1 Checkpoint Interactions Predict Response to Anti-PD-1/PD-L1 Therapy in NSCLC

Gumuzio J, Sanchez-Magraner L, Miles J, et al.

What This Study Shows

Building on the breakthrough PD-1/PD-L1 findings, this study shows that measuring a second immune checkpoint—CTLA-4/CD80—provides additional predictive power. When both checkpoints are actively engaged, patients show the best responses to immunotherapy.

Critically, neither biomarker predicted response to chemotherapy, confirming they are specific predictors of immunotherapy benefit—not just general prognostic markers.

Key Findings

35
months

"Double High" Survival

Patients with high interaction at BOTH checkpoints (PD-1/PD-L1 + CTLA-4/CD80) had median overall survival of 35 months—the best outcomes in the study.

67
patients

Study Cohort

NSCLC patients treated with anti-PD-1/PD-L1 immunotherapy, with parallel assessment of both checkpoint pathways.

Combined Biomarker Power

The study stratified patients by both checkpoint interactions:

Both High
35
months median OS
PD-1/PD-L1 High Only
28
months median OS
CTLA-4/CD80 High Only
18
months median OS
Both Low
8
months median OS

Specificity for Immunotherapy

A critical finding: these biomarkers specifically predict response to immune checkpoint inhibitors, not chemotherapy. In a chemotherapy-treated control group, neither PD-1/PD-L1 nor CTLA-4/CD80 interaction predicted outcomes.

This confirms the biomarkers are measuring the mechanism of action—immune checkpoint engagement—rather than being general tumor biology markers.

Clinical Implications

  • 🎯 Multi-pathway profiling: Assessing both checkpoints provides a more complete picture of tumor immune evasion mechanisms.
  • 💊 Combination therapy guidance: Patients with high CTLA-4/CD80 but low PD-1/PD-L1 might benefit from ipilimumab-based regimens.
  • Mechanism confirmation: The chemotherapy non-prediction confirms biomarker specificity for ICI mechanisms.

Learn More

Abstract

The CTLA-4/CD80 pathway represents a distinct checkpoint axis regulating T-cell priming in lymphoid tissue. We hypothesized that quantitative assessment of both CTLA-4/CD80 and PD-1/PD-L1 interactions would improve predictive stratification for anti-PD-1/PD-L1 therapy. Using iFRET on the QF-Pro platform, we measured both checkpoint interactions in 67 NSCLC patients treated with anti-PD-1/PD-L1 monotherapy or combination therapy.

Methods

iFRET Assays: Sequential dual-checkpoint iFRET was performed on FFPE sections. PD-1/PD-L1 interaction was measured at the tumor-immune interface; CTLA-4/CD80 interaction was assessed in tumor-infiltrating lymphocyte (TIL) clusters.

Stratification: Patients were classified into four groups based on above/below median iFRET values for each checkpoint pathway.

Control Cohort: A separate cohort of 42 NSCLC patients treated with platinum-doublet chemotherapy served as a specificity control.

Key Findings

35
months

Double-High Median OS

Patients with high iFRET for both PD-1/PD-L1 AND CTLA-4/CD80 achieved 35-month median OS (95% CI: 28.1-41.9).

8
months

Double-Low Median OS

Double-low patients showed 8-month median OS, representing a 4.4-fold difference from double-high (P < 0.0001).

NS
chemotherapy

Specificity Control

Neither biomarker showed significant association with OS in chemotherapy-treated patients (P = 0.71 and P = 0.58), confirming ICI-specificity.

Biological Rationale

Complementary pathways: PD-1/PD-L1 primarily regulates T-cell effector function at the tumor site, while CTLA-4/CD80 modulates T-cell priming and regulatory T-cell (Treg) function. High engagement of both pathways indicates tumors employing multiple immune evasion mechanisms.

Response prediction: Paradoxically, high checkpoint engagement predicts better ICI response—tumors actively suppressing immunity via these checkpoints are vulnerable when those checkpoints are blocked.

Multivariate Analysis

Cox proportional hazards modeling including age, ECOG PS, stage, histology, and both iFRET biomarkers confirmed independent prognostic value:

  • 📊 PD-1/PD-L1 iFRET: HR = 0.42 (95% CI: 0.26-0.68), P = 0.0003
  • 📊 CTLA-4/CD80 iFRET: HR = 0.61 (95% CI: 0.39-0.95), P = 0.028
  • 📊 Combined model C-statistic: 0.74 vs. 0.62 for PD-L1 TPS alone

Related Glossary Terms