Evidence map›Paper›PMID 42190314›Full record

ArticleESMO open2026

Concordance of pathologic response assessment between local and central review in melanoma: a post hoc analysis of KEYMAKER-U02 substudy 02C.

M Tetzlaff, J M Taube, G V Long, R Dummer, C Robert, A M Menzies, A Hill, C Gaudy-Marqueste, D C Portnoy, C Lebbe and 5 more

Abstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in ESMO open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0citing papers in PubMed
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1 · What the graph read from it

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2 · The registry

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3 · Its place in the literature

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0 citing papers in PubMed.

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4 · The record

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5 · Who and what money

Authors and funding

15 authors.

M TetzlaffDepartments of Pathology and Dermatology, Dermatopathology and Oral Pathology Unit, University of California San Francisco, San Francisco, USA.
J M TaubeDepartment of Dermatology, The Mark Foundation Center for Advanced Genomics and Imaging at Johns Hopkins and Bloomberg-Kimmel Institute for Cancer Immunotherapy, Baltimore, USA.
G V LongDepartment of Medical Oncology, Melanoma Institute Australia, The University of Sydney, and Mater and Royal North Shore Hospitals, Sydney, Australia.
R DummerDepartment of Dermatology, University Hospital Zurich, Zurich, Switzerland.
C RobertDermatology Unit, Gustave Roussy, Paris, France; Paris-Saclay University, Villejuif, France.
A M MenziesDepartment of Medical Oncology, Melanoma Institute Australia, The University of Sydney, and Mater and Royal North Shore Hospitals, Sydney, Australia.
A HillTasman Health Care, Southport, Australia.
C Gaudy-MarquesteDermatology and Skin Cancer Department, Aix-Marseille University, APHM, Hôpital Timone, CEPCM, Marseille, France.
D C PortnoyWest Cancer Center & Research Institute, Germantown, USA.
C LebbeUniversité Paris Cité, AP-HP Dermato-Oncology and CIC, Cancer Institute AP-HP, Nord Paris Cité, INSERM U1342 - Equipe 1 - CNRS EMR8000, Saint Louis Hospital, Paris, France.
R KrishnanMerck & Co., Inc., Rahway, USA.
J XuMerck & Co., Inc., Rahway, USA.
M Fukunaga-KalabisMerck & Co., Inc., Rahway, USA.
C KreplerMerck & Co., Inc., Rahway, USA.
R A ScolyerMelanoma Institute Australia, The University of Sydney, Sydney, Australia; Faculty of Medicine and Health, The University of Sydney, Sydney, Australia; Royal Prince Alfred Hospital and NSW Health Pathology, Charles Perkins Centre, The University of Sydney, Sydney, Australia. Electronic address: richard.scolyer@health.nsw.gov.au.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSubstudy 02C of the phase I-II KEYMAKER-U02 study was designed to evaluate neoadjuvant pembrolizumab as monotherapy and in combination with investigational agents, followed by surgery and adjuvant pembrolizumab in participants with resectable stage IIIB-D melanoma. Here, we report a post hoc analysis of concordance of pathologic response assessment between local and central review and among central reviewers in the KEYMAKER-U02 substudy 02C. PATIENTS AND

methodsParticipants received neoadjuvant pembrolizumab plus vibostolimab, pembrolizumab plus gebasaxturev, or pembrolizumab monotherapy followed by resection and adjuvant pembrolizumab. Pathologic response was categorized by percent age of residual viable tumor (%RVT) in the treated tumor bed as follows: pathologic complete response (pCR; 0% RVT), near-pCR (RVT >0% but ≤10%), partial pathologic response (pPR; RVT >10% but ≤50%), and pathologic nonresponse (pNR; RVT >50%).

resultsBy local review of 60 participants, 24 (40%) had pCR, 7 (12%) had near-pCR, 12 (20%) had pPR, and 17 (28%) had pNR. By central review of 60 participants, 23 (38%) had pCR, 7 (12%) had near-pCR, 14 (23%) had pPR, and 16 (27%) had pNR. The weighted kappa for concordance between local and central review for these categories was 0.79 (95% CI 0.70-0.89). The three central reviewers agreed on the response category for 54 of 61 participants (89%). For the seven participants (11%) without agreement, the maximum difference in response was one category; for four of these participants, the dissenting response assessment was close to a %RVT category cut point. The weighted Gwet's agreement coefficient was 0.94 (95% CI 0.90-0.98).

conclusionThese results confirm a high level of concordance in pathologic response assessment between local and central review and among central reviewers and provide confidence in the accuracy of pathologic response assessment following neoadjuvant therapy.

Indexed as

Antibodies, Monoclonal, HumanizedMelanomaAgedFemaleHumansMaleMiddle AgedNeoadjuvant TherapyPathologic Complete ResponseAntibodies, Monoclonal, Humanizedpembrolizumabcentral reviewlocal reviewmelanomaneoadjuvantpathologic responsepembrolizumab

Identifiers

PMID42190314
PMCPMC13234465

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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.