Trial reportDiagnostic pathology2016
Development of a programmed cell death ligand-1 immunohistochemical assay validated for analysis of non-small cell lung cancer and head and neck squamous cell carcinoma.
Trial report in Diagnostic pathology, 2016. 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 98 papers, 4 of them syntheses 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
98 citing papers in PubMed, 4 syntheses or guidelines pooled it, 177 citations in OpenAlex.
- Tumour PD-L1 Expression in Small-Cell Lung Cancer: A Systematic Review and Meta-Analysis.Cells · 2020Pooled it
- Comparability of PD-L1 immunohistochemistry assays for non-small-cell lung cancer: a systematic review.Histopathology · 2020Pooled it
- "Interchangeability" of PD-L1 immunohistochemistry assays: a meta-analysis of diagnostic accuracy.Modern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc · 2020Pooled it
- PD-L1 diagnostic tests: a systematic literature review of scoring algorithms and test-validation metrics.Diagnostic pathology · 2018Pooled 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
- Trastuzumab deruxtecan in HER2-expressing gynecologic cancers from DESTINY-PanTumor02: antitumor activity, safety, and exploratory biomarker analyses.Journal of gynecologic oncology · 2026Trial
- IMpower010: 5-Year Outcomes of Atezolizumab in Japanese Patients With Resected Stage IB-IIIA Non-Small Cell Lung Cancer.Cancer science · 2026Trial
- Anti-LAG-3 Antibody LBL-007 plus Tislelizumab and Chemotherapy as First-Line Therapy for Advanced Nasopharyngeal Carcinoma: A Multicenter Phase 2 Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026Trial
- Durvalumab ± Tremelimumab + Platinum-Etoposide in Extensive-Stage Small Cell Lung Cancer (CASPIAN): Outcomes by PD-L1 Expression and Tissue Tumor Mutational Burden.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024Trial
- Durvalumab With or Without Tremelimumab in Combination With Chemotherapy as First-Line Therapy for Metastatic Non-Small-Cell Lung Cancer: The Phase III POSEIDON Study.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023Trial
- Adjuvant atezolizumab in Japanese patients with resected stage IB-IIIA non-small cell lung cancer (IMpower010).Cancer science · 2022Trial
- Automated image analysis of NSCLC biopsies to predict response to anti-PD-L1 therapy.Journal for immunotherapy of cancer · 2019Trial
- Durvalumab as third-line or later treatment for advanced non-small-cell lung cancer (ATLANTIC): an open-label, single-arm, phase 2 study.The Lancet. Oncology · 2018Trial
- Article
- Chorus line in oral squamous cell carcinoma: How stromal and immune players orchestrate tumor progression (Review).International journal of molecular medicine · 2026Review
- PD-L1-stratified health-related quality of life in solid tumors: pembrolizumab versus chemotherapy-a narrative review.Frontiers in medicine · 2026Review
- Comparative effectiveness of different adjuvant therapy modalities for stage IIIA-N2 non-small cell lung cancer following complete resection: a retrospective analysis.American journal of cancer research · 2026Article
- Association between autologous formalin-fixed tumor vaccine (AFTV) therapy, molecular pathological markers, and survival outcomes in glioblastoma.Brain tumor pathology · 2025Article
- Durable response to nivolumab in combination with regional hyperthermia in a patient with PD-L1-negative metastatic head and neck squamous cell carcinoma.Cancer immunology, immunotherapy : CII · 2025Article
- Adding checkpoint inhibitors to first-line chemotherapy for NUT carcinoma patients.NPJ precision oncology · 2025Article
38 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
11 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundA high-quality programmed cell-death ligand 1 (PD-L1) diagnostic assay may help predict which patients are more likely to respond to anti-programmed cell death-1 (PD-1)/PD-L1 antibody-based cancer therapy. Here we describe a PD-L1 immunohistochemical (IHC) staining protocol developed by Ventana Medical Systems Inc. and key analytical parameters of its use in formalin-fixed, paraffin-embedded (FFPE) samples of non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma (HNSCC).
methodsAn anti-human PD-L1 rabbit monoclonal antibody (SP263) was optimized for use with the VENTANA OptiView DAB IHC Detection Kit on the automated VENTANA BenchMark ULTRA platform. The VENTANA PD-L1 (SP263) Assay was validated for use with FFPE NSCLC and HNSCC tissue samples in a series of studies addressing sensitivity, specificity, robustness, and precision. Samples from a subset of 181 patients from a Phase 1/2 study of durvalumab (NCT01693562) were analyzed to determine the optimal PD-L1 staining cut-off for enriching the probability of responses to treatment. The scoring algorithm was defined using statistical analysis of clinical response data from this clinical trial and PD-L1 staining parameters in HNSCC and NSCLC tissue. Inter-reader agreement was established by three pathologists who evaluated 81 NSCLC and 100 HNSCC samples across the range of PD-L1 expression levels.
resultsThe VENTANA PD-L1 (SP263) Assay met all pre-defined acceptance criteria. For both cancer types, a cut-off of 25 % of tumor cells with PD-L1 membrane staining of any intensity best discriminated responders from nonresponders. Samples with staining above this value were deemed to have high PD-L1 expression, and those with staining below it were deemed to have low or no PD-L1 expression. Inter-reader agreement on PD-L1 status was 97 and 92 % for NSCLC and HNSCC, respectively.
conclusionsThese results highlight the robustness and reproducibility of the VENTANA PD-L1 (SP263) Assay and support its suitability for use in the evaluation of NSCLC and HNSCC FFPE tumor samples using the devised ≥25 % tumor cell staining cut-off in a clinical setting. The clinical utility of the PD-L1 diagnostic assay as a predictive biomarker will be further validated in ongoing durvalumab studies.
trial registrationClinicalTrials.gov: NCT01693562.
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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.