Trial reportJournal for immunotherapy of cancer2019
Automated image analysis of NSCLC biopsies to predict response to anti-PD-L1 therapy.
Trial report in Journal for immunotherapy of cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01693562 (A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI4736 in Subjects With Advanced Solid Tumors), which is not on this map. Cited by 66 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI4736 in Subjects With Advanced Solid Tumors
Who cites it
66 citing papers in PubMed, 1 synthesis or guideline pooled it, 104 citations in OpenAlex.
- Artificial intelligence-based non-small cell lung cancer transcriptome RNA-sequence analysis technology selection guide.Frontiers in bioengineering and biotechnology · 2023Pooled it
- Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy from a First-in-Human Study of Volrustomig, a Novel PD-1/CTLA-4 Bispecific Antibody.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026Trial
- A Randomized Phase II Study of MEDI0680 in Combination with Durvalumab versus Nivolumab Monotherapy in Patients with Advanced or Metastatic Clear-cell Renal Cell Carcinoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2022Trial
- Matching Patients With Cell Surface-Targeted Clinical Trials Using Large Language Models.JCO precision oncology · 2026Article
- CRISPR/Cas9-mediated PD-1 attenuation enhances tumor infiltrating lymphocyte-based adoptive cellular therapy in humanized-PDX model of hepatocellular carcinoma.Translational oncology · 2025Article
- Deep Learning and Image Generator Health Tabular Data (IGHT) for Predicting Overall Survival in Patients With Colorectal Cancer: Retrospective Study.JMIR medical informatics · 2025Article
- Assessment of PD-L1 expression and tumour infiltrating lymphocytes in early-stage non-small cell lung carcinoma with artificial intelligence algorithms.Journal of clinical pathology · 2025Article
- PD-L1 Scoring Models for Non-Small Cell Lung Cancer in China: Current Status, AI-Assisted Solutions and Future Perspectives.Thoracic cancer · 2025Review
- The Impact of the Tumor Microenvironment on the Effect of IL-1β Blockade in NSCLC: Biomarker Analyses from CANOPY-1 and CANOPY-N Trials.Cancer research communications · 2025Article
- Biological and clinical significance of tumour-infiltrating lymphocytes in the era of immunotherapy: a multidimensional approach.Nature reviews. Clinical oncology · 2025Review
- Role of Artificial Intelligence in Nanomedicine and Organ-specific Therapy: An Updated Review.Current drug targets · 2025Review
- Overview on biomarkers for immune oncology drugs.Exploration of targeted anti-tumor therapy · 2025Review
- Prediction performance comparison of biomarkers for response to immune checkpoint inhibitors in advanced non-small cell lung cancer.Thoracic cancer · 2024Article
- Digital Pathology for Better Clinical Practice.Cancers · 2024Review
- Review
- CD57-positive CD8 + T cells define the response to anti-programmed cell death protein-1 immunotherapy in patients with advanced non-small cell lung cancer.NPJ precision oncology · 2024Article
- Refining PD-1/PD-L1 assessment for biomarker-guided immunotherapy: A review.Biomolecules & biomedicine · 2024Review
- Challenges Coexist with Opportunities: Spatial Heterogeneity Expression of PD-L1 in Cancer Therapy.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2024Review
- Article
- The Mutational, Prognostic, and Therapeutic Landscape of Neuroendocrine Neoplasms.The oncologist · 2023Article
6 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 7 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundImmune checkpoint therapies (ICTs) targeting the programmed cell death-1 (PD1)/programmed cell death ligand-1 (PD-L1) pathway have improved outcomes for patients with non-small cell lung cancer (NSCLC), particularly those with high PD-L1 expression. However, the predictive value of manual PD-L1 scoring is imperfect and alternative measures are needed. We report an automated image analysis solution to determine the predictive and prognostic values of the product of PD-L1+ cell and CD8+ tumor infiltrating lymphocyte (TIL) densities (CD8xPD-L1 signature) in baseline tumor biopsies.
methodsArchival or fresh tumor biopsies were analyzed for PD-L1 and CD8 expression by immunohistochemistry. Samples were collected from 163 patients in Study 1108/NCT01693562, a Phase 1/2 trial to evaluate durvalumab across multiple tumor types, including NSCLC, and a separate cohort of 199 non-ICT- patients. Digital images were automatically scored for PD-L1+ and CD8+ cell densities using customized algorithms applied with Developer XD™ 2.7 software.
resultsFor patients who received durvalumab, median overall survival (OS) was 21.0 months for CD8xPD-L1 signature-positive patients and 7.8 months for signature-negative patients (p = 0.00002). The CD8xPD-L1 signature provided greater stratification of OS than high densities of CD8+ cells, high densities of PD-L1+ cells, or manually assessed tumor cell PD-L1 expression ≥25%. The CD8xPD-L1 signature did not stratify OS in non-ICT patients, although a high density of CD8+ cells was associated with higher median OS (high: 67 months; low: 39.5 months, p = 0.0009) in this group.
conclusionsAn automated CD8xPD-L1 signature may help to identify NSCLC patients with improved response to durvalumab therapy. Our data also support the prognostic value of CD8+ TILS in NSCLC patients who do not receive ICT.
trial registrationClinicalTrials.gov identifier: NCT01693562 . Study code: CD-ON-MEDI4736-1108. Interventional study (ongoing but not currently recruiting). Actual study start date: August 29, 2012. Primary completion date: June 23, 2017 (final data collection date for primary outcome measure).
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.