Evidence map›Paper›PMID 40764401›Full record

ArticleNPJ precision oncology2025

Inflammation and limited adaptive immunity predict worse outcomes on immunotherapy in head and neck cancer.

Lisa Paschold, Christoph Schultheiss, Paul Schmidt-Barbo, Konrad Klinghammer, Dennis Hahn, Mareike Tometten, Philippe Schafhausen, Markus Blaurock, Anna Brandt, Ingunn Westgaard and 4 more

Registry-linked trialAbstract read
In one paragraph

Article in NPJ precision oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05075122 (Phase 2 Multicenter Study Investigating the Tolerability and Efficacy of UV1 Vaccine in Patients With Recurrent or Metastatic PD-L1 Positive), which is not on this map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT05075122 phase2unknown statusnot on this map

Phase 2 Multicenter Study Investigating the Tolerability and Efficacy of UV1 Vaccine in Patients With Recurrent or Metastatic PD-L1 Positive (CPS≥1) Head and Neck Squamous Cell Carcinoma Planned for First-line Treatment With Pembrolizumab

TypeinterventionalSponsorMartin-Luther-Universität Halle-WittenbergRan2021 to 2025Enrolled75ConditionsHead and Neck Squamous Cell CarcinomaArmsUV1, Sargramostim for Injection, Pembrolizumab injection
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Lisa Paschold *Department of Internal Medicine IV, Oncology/Hematology, Martin-Luther-University Halle-Wittenberg, Halle (Saale), Germany.
Christoph Schultheiss *Division of Medical Oncology, University Hospital Basel, Basel, Switzerland.
Paul Schmidt-BarboDivision of Medical Oncology, University Hospital Basel, Basel, Switzerland.
Konrad KlinghammerDepartment of Hematology and Oncology, Campus Benjamin Franklin, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.
Dennis HahnDepartment of Hematology, Oncology, Stem-Cell Transplantation and Palliative Care, Klinikum Stuttgart, Stuttgart, Germany.
Mareike TomettenDepartment of Hematology, Oncology, Hemostaseology and Stem Cell Transplantation, Medical Faculty, RWTH Aachen University, Aachen, Germany.
Philippe SchafhausenDepartment of Oncology, Hematology and Bone Marrow Transplantation with Section of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Markus BlaurockDepartment of Otorhinolaryngology, Head and Neck Surgery, University Medicine Greifswald, Greifswald, Germany.
Anna BrandtDivision of Medical Oncology, University Hospital Basel, Basel, Switzerland.
Ingunn WestgaardUltimovacs, Oslo, Norway.
Simone KowollKoordinierungszentrum für Klinische Studien Halle (KKS), Medical Faculty, Martin-Luther-University Halle-Wittenberg, Halle (Saale), Germany.
Alexander SteinHematology-Oncology Practice Eppendorf (HOPE), Hamburg, Germany.
Axel HinkeClinical Cancer Research Consulting (CCRC), Düsseldorf, Germany.
Mascha BinderDivision of Medical Oncology, University Hospital Basel, Basel, Switzerland. mascha.binder@unibas.ch.

Funding

Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung 10.001.762
6 · The paper itself

Abstract

Most patients with relapsed or metastatic head and neck squamous cell carcinoma (rmHNSCC) do not experience durable responses to PD-1 immune checkpoint inhibitors. PD-L1 tissue expression is the most commonly assessed response marker, but an insufficient predictor of treatment outcome. To identify suitable response biomarkers, we profiled the FOCUS trial (Registered at ClinicalTrials.gov: NCT05075122) cohort for several blood- and tissue-based markers. PD-L1 levels in the tumor or tumor microenvironment were not associated with treatment benefit. In contrast, inflammation-related markers such as IL-6, sCD25, and sTIM-3, as well as high peripheral neutrophils, cell-free DNA levels, and T cell receptor repertoire clonality, were associated with poor clinical outcomes. Patients lacking these high-risk markers performed remarkably well on inhibition of immune checkpoints with pembrolizumab. Biomarker-guided patient selection for pembrolizumab monotherapy or novel combinatorial approaches-potentially including anti-inflammatory agents-for patients with immune-impaired, inflammatory profiles may be the next step in personalizing immunotherapy for these hard-to-treat patients.

Identifiers

PMID40764401
PMCPMC12325939

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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.