Evidence map›Paper›PMID 40511820›Full record

ArticleFuture oncology (London, England)2025

LiGeR-HN phase III trials of petosemtamab + pembrolizumab and petosemtamab monotherapy in recurrent or metastatic HNSCC.

Jean-Pascal Machiels, Jérôme Fayette, Robert Haddad, Douglas Adkins, Maura Gillison, Kevin J Harrington, Sung-Bae Kim, Christophe Le Tourneau, Amanda Psyrri, Ari Rosenberg and 10 more

2 registry-linked trialsAbstract readClinical Trial Protocol
In one paragraph

Article in Future oncology (London, England), 2025. 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 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing 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.

NCT06496178 phase3recruitingnot on this map

A Phase 3 Open-label, Randomized Controlled Study to Evaluate the Efficacy and Safety of Petosemtamab Compared With Investigator's Choice Monotherapy Treatment in Previously Treated Patients With Incurable, Metastatic/Recurrent Head and Neck Squamous Cell Carcinoma

TypeinterventionalSponsorMerus B.V.Ran2024 to 2029Enrolled600ConditionsHead and Neck Squamous Cell CarcinomaArmsPetosemtamab, Investigator's Choice
NCT06525220 phase3recruitingnot on this map

A Phase 3 Randomized, Open-label Study to Evaluate the Efficacy and Safety of Petosemtamab Plus Pembrolizumab vs Pembrolizumab in First-line Treatment of Recurrent or Metastatic PD-L1+ Head and Neck Squamous Cell Carcinoma

TypeinterventionalSponsorMerus B.V.Ran2024 to 2030Enrolled700ConditionsHead and Neck Squamous Cell CarcinomaArmsPetosemtamab, Pembrolizumab
3 · Its place in the literature

Who cites it

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

  1. 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

20 authors.

Jean-Pascal MachielsAdult and Pediatric Oncology and Hematology Center, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium.ORCID 0000-0001-6369-9742
Jérôme FayetteLéon Bérard Center, University of Lyon, Lyon, France.ORCID 0000-0002-8126-7019
Robert HaddadDivision of Head and Neck Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.ORCID 0000-0003-1413-0079
Douglas AdkinsDivision of Oncology, Washington University School of Medicine, St. Louis, MO, USA.ORCID 0000-0003-3207-8227
Maura GillisonDepartment of Thoracic/Head & Neck Medical Oncology, MD Anderson Cancer Center, Houston, TX, USA.ORCID 0000-0002-8145-5749
Kevin J HarringtonDivision of Radiotherapy and Imaging, The Institute of Cancer Research/Royal Marsden, London, UK.ORCID 0000-0002-6014-348X
Sung-Bae KimAsan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.ORCID 0000-0001-5588-8332
Christophe Le TourneauEarly Phase Clinical Trials Program & Head & Neck Oncology, Department of Drug Development & Innovation (D3i), Institut Curie, Paris, France.ORCID 0000-0001-9772-4686
Amanda PsyrriInternal Medicine and Medical Oncology, National Kapodistrian University of Athens Medical School, Athens, Greece.ORCID 0000-0002-4321-766X
Ari RosenbergSection of Hematology/Oncology, University of Chicago, Chicago, IL, USA.ORCID 0000-0002-8606-2987
Lillian L SiuCancer Clinical Research Unit (CCRU), Princess Margaret Cancer Centre, Toronto, ON, Canada.ORCID 0000-0002-3500-0540
Makoto TaharaDepartment of Head and Neck Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan.ORCID 0000-0001-9035-3106
William N WilliamDepartments of Thoracic Oncology and Head and Neck Oncology, Grupo Oncoclínicas, São Paulo, Brazil.ORCID 0000-0001-5008-8854
Jim FordClinical Operations, Merus N.V., Utrecht, Netherlands.
Shekeab JauhariClinical Development, Merus N.V., Utrecht, Netherlands.
Rebecca PyleClinical Operations, Merus N.V., Utrecht, Netherlands.
Yu-Ming ShenBiostatistics, Merus N.V., Utrecht, Netherlands.
David YaoClinical Development, Merus N.V., Utrecht, Netherlands.
Fabian ZohrenClinical Development, Merus N.V., Utrecht, Netherlands.
Everett VokesDepartment of Medicine, University of Chicago Medical Center, Chicago, IL, USA.ORCID 0000-0002-8645-8068

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Patients with recurrent/metastatic (r/m) head and neck squamous cell carcinoma (HNSCC) have limited treatment options and a dismal prognosis, especially when their cancer is resistant to standard treatments like anti-programmed cell death protein 1 and platinum-based therapies. Petosemtamab - a human, common light chain, bispecific antibody with enhanced antibody-dependent cellular cytotoxicity targeting epidermal growth factor receptor (EGFR) and leucine-rich repeat-containing G-protein coupled receptor 5 (LGR5) - demonstrated antitumor activity in r/m HNSCC. In many tumor types, including HNSCC, EGFR is an oncogenic driver, while LGR5 is upregulated. LGR5 can potentiate the wingless-type integration site (WNT)/β-catenin signaling pathway in response to ligand binding, stimulating cancer stem cell proliferation and self-renewal. This article describes two registration-intent, open-label, randomized phase III trials evaluating efficacy and safety of petosemtamab. LiGeR-HN1 (NCT06525220) evaluates petosemtamab plus pembrolizumab versus pembrolizumab as first-line therapy for patients with programmed cell death ligand 1-positive r/m HNSCC. LiGeR-HN2 (NCT06496178) evaluates petosemtamab versus investigator's choice of monotherapy (cetuximab, methotrexate, or docetaxel) in patients with previously treated r/m HNSCC. Primary endpoints in both trials are objective response rate per Response Evaluation Criteria in Solid Tumors version 1.1 by blinded independent central review, and overall survival. Both trials are recruiting at the time of publication.

Indexed as

Antibodies, BispecificAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsHead and Neck NeoplasmsNeoplasm Recurrence, LocalSquamous Cell Carcinoma of Head and NeckClinical Trials, Phase III as TopicHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicTreatment OutcomeAntibodies, BispecificAntibodies, Monoclonal, HumanizedpembrolizumabEGFRHNSCCLGR5LiGeR-HNLiGeR-HN1LiGeR-HN2petosemtamab

Identifiers

PMID40511820
PMCPMC12218485

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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.