Evidence map›Paper›PMID 39489541›Full record

Observational studyJournal for immunotherapy of cancer2024

Multicenter validation of an RNA-based assay to predict anti-PD-1 disease control in patients with recurrent or metastatic head and neck squamous cell carcinoma: the PREDAPT study.

Kevin C Flanagan, Jon Earls, Jeffrey Hiken, Rachel L Wellinghoff, Michelle M Ponder, Howard L McLeod, William H Westra, Vera Vavinskaya, Leisa Sutton, Ida Deichaite and 19 more

2 registry-linked trialsAbstract readMulticenter StudyObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Journal for immunotherapy of cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing 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.

NCT04510129 recruitingnot on this map

Predicting Immunotherapy Efficacy from Analysis of Pre-treatment Tumor Biopsies

TypeobservationalSponsorCofactor Genomics, Inc.Ran2020 to 2027Enrolled1,650ConditionsCancer of Head and Neck, Lung Cancer, Nonsmall Cell, Small-cell Lung Cancer, Urothelial CarcinomaArmsOncoPrism™ assay
NCT05296135 withdrawnnot on this map

Predicting Immunotherapy Efficacy From Analysis of Pre-treatment Tumor Biopsies, Head and Neck Squamous Cell Cancer, Study 2

TypeobservationalSponsorCofactor Genomics, Inc.Ran2020 to 2025Enrolled0ConditionsHead and Neck Squamous Cell CarcinomaArmsOncoPrism-HNSCC™
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Review
  3. Article
  4. Review
  5. Review
  6. Review
  7. Article
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

29 authors.

Kevin C FlanaganCofactor Genomics Inc, Saint Louis, Missouri, USA kevin_flanagan@cofactorgenomics.com.ORCID 0009-0005-3364-1677
Jon EarlsCofactor Genomics Inc, Saint Louis, Missouri, USA.
Jeffrey HikenCofactor Genomics Inc, Saint Louis, Missouri, USA.
Rachel L WellinghoffCofactor Genomics Inc, Saint Louis, Missouri, USA.
Michelle M PonderCofactor Genomics Inc, Saint Louis, Missouri, USA.
Howard L McLeodUtah Tech University, St George, Utah, USA.
William H WestraIcahn School of Medicine at Mount Sinai, New York, New York, USA.
Vera VavinskayaDivision of Hematology and Oncology, UCSD Moores Cancer Center, La Jolla, California, USA.
Leisa SuttonUCSD Moores Cancer Center, La Jolla, California, USA.
Ida DeichaiteRadiation Medicine and Applied Sciences, UCSD Moores Cancer Center, La Jolla, California, USA.
Orlan K MacdonaldCancer Care Northwest, Spokane Valley, Washington, USA.
Karim WelayaCoxHealth Medical Oncology, Springfield, Missouri, UK.
James WadeDecatur Memorial Hospital, Decatur, Illinois, USA.
Georges AzziHoly Cross Hospital Medical Group, Fort Lauderdale, Florida, USA.
Andrew W PippasJohn B Amos Cancer Center, Columbus Regional Research Institute, Centricity Research, Columbus, Georgia, USA.
Jennifer SlimMulticare Institute for Research and Innovation, Tacoma, Washington, USA.
Bruce BankNorthwest Oncology & Hematology, Elk Grove Village, Illinois, USA.
Xingwei SuiProvidence Regional Cancer System, Lacey, Washington, USA.
Steven E KossmanSharp Clinical Oncology Research, San Diego, California, USA.
Todd D ShenkenbergValley Cancer Associates, Harlingen, Texas, USA.
Warren L AlexanderWilliam Beaumont Army Medical Center and The Geneva Foundation, Fort Bliss, Texas, USA.
Katharine A PriceMayo Clinic, Rochester, Minnesota, USA.
Jessica LeyDivision of Oncology, Department of Medicine, Washington University in St Louis School of Medicine, St Louis, Missouri, USA.
David N MessinaCofactor Genomics Inc, Saint Louis, Missouri, USA.
Jarret I GlasscockCofactor Genomics Inc, Saint Louis, Missouri, USA.
A Dimitrios ColevasStanford University, Stanford, California, USA.
Ezra E W CohenDivision of Hematology and Oncology, University of California San Diego, La Jolla, California, USA.
Douglas AdkinsDivision of Oncology, Department of Medicine, Washington University in St Louis School of Medicine, St Louis, Missouri, USA.
Eric J DuncavageDepartment of Pathology and Immunology, Washington University in St Louis School of Medicine, St Louis, Missouri, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDespite advances in cancer care and detection, >65% of patients with squamous cell cancer of the head and neck (HNSCC) will develop recurrent and/or metastatic disease. The prognosis for these patients is poor with a 5-year overall survival of 39%. Recent treatment advances in immunotherapy, including immune checkpoint inhibitors like pembrolizumab and nivolumab, have resulted in clinical benefit in a subset of patients. There is a critical clinical need to identify patients who benefit from these antiprogrammed cell death protein 1 (anti-PD-1) immune checkpoint inhibitors.

methodsHere, we report findings from a multicenter observational study, PREDicting immunotherapy efficacy from Analysis of Pre-treatment Tumor biopsies (PREDAPT), conducted across 17 US healthcare systems. PREDAPT aimed to validate OncoPrism-HNSCC, a clinical biomarker assay predictive of disease control in patients with recurrent or metastatic HNSCC treated with anti-PD-1 immune checkpoint inhibitors as a single agent (monotherapy) and in combination with chemotherapy (chemo-immunotherapy). The test used RNA-sequencing data and machine learning models to score each patient and place them into groups of low, medium, or high.

resultsThe OncoPrism-HNSCC prediction significantly correlated with disease control in both the monotherapy cohort (n=62, p=0.004) and the chemo-immunotherapy cohort (n=50, p=0.01). OncoPrism-HNSCC also significantly predicted progression-free survival in both cohorts (p=0.015 and p=0.037, respectively). OncoPrism-HNSCC had more than threefold higher specificity than programmed death-ligand 1 combined positive score and nearly fourfold higher sensitivity than tumor mutational burden for predicting disease control.

conclusionsHere, we demonstrate the clinical validity of the OncoPrism-HNSCC assay in identifying patients with disease control in response to anti-PD-1 immune checkpoint inhibitors. TRIAL REGISTRATION NUMBER: NCT04510129.

Indexed as

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and NeckAdultAgedBiomarkers, TumorFemaleHumansImmune Checkpoint InhibitorsMaleMiddle AgedNeoplasm MetastasisNeoplasm Recurrence, LocalProgrammed Cell Death 1 ReceptorBiomarkers, TumorImmune Checkpoint InhibitorsPDCD1 protein, humanProgrammed Cell Death 1 Receptorbiomarkerhead and neck cancerimmune checkpoint inhibitornext generation sequencing (NGS)tumor mutation burden (TMB)

Identifiers

PMID39489541
PMCPMC11535711

What OpenQuestion holds

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LicenceCC BY-NC
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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.