Evidence map›Paper›PMID 40796223›Full record

Trial reportJournal for immunotherapy of cancer2025

Phase II study of retifanlimab in patients with recurrent locally advanced or metastatic Merkel cell carcinoma (POD1UM-201).

Giovanni Grignani, Piotr Rutkowski, Céleste Lebbé, Michele Guida, Caroline Gaudy-Marqueste, Francesco Spagnolo, Melissa Burgess, Federica Morano, Henri Montaudié, Roberta Depenni and 6 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal for immunotherapy of cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03599713 (A Phase 2 Study of INCMGA00012 in Participants With Metastatic Merkel Cell Carcinoma), which is not on this map. Cited by 22 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 4 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.

NCT03599713 phase2completednot on this map

A Phase 2 Study of INCMGA00012 in Participants With Metastatic Merkel Cell Carcinoma (POD1UM-201)

TypeinterventionalSponsorIncyte CorporationRan2019 to 2024Enrolled107ConditionsMetastatic Merkel Cell CarcinomaArmsRetifanlimab
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
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  4. Pooled it
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  18. Merkel Cell Carcinoma.Hematology/oncology clinics of North America · 2024
    Review
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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

16 authors.

Giovanni GrignaniDepartment of Oncology, Candiolo Cancer Institute, FPO - IRCCS, Candiolo, Italy giovanni.grignani@ircc.it.ORCID http://orcid.org/0000-0001-5515-569X
Piotr RutkowskiDepartment of Soft Tissue/Bone Sarcoma and Melanoma, The Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw, Warsaw, Poland.
Céleste LebbéUniversité Paris Cité, AP-HP Dermato-oncology, CIC, Cancer Institute AP-HP. Nord-Paris Cité, INSERM U1342 - Equipe 1 - CNRS EMR8000, Saint Louis Hospital, Paris, France.
Michele GuidaUnit Melanoma and Rare Tumors, IRCCS Istituto Tumori Giovanni Paolo II, Bari, Italy.ORCID http://orcid.org/0000-0001-8411-0319
Caroline Gaudy-MarquesteAPHM, Service de Dermatologie et de Cancérologie Cutanée, Aix-Marseille University, Marseille, France.
Francesco SpagnoloMedical Oncology 2, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.
Melissa BurgessUPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, USA.
Federica MoranoOncologia Medica 1, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.
Henri MontaudiéDepartment of Dermatology, Centre Hospitalier Universitaire de Nice, Université Côte d'Azur, Nice, France.
Roberta DepenniDepartment of Oncology and Haematology, Division of Oncology, University Hospital of Modena, Modena, Italy.
Francesca SpadaDivision of Gastrointestinal Medical Oncology and Neuroendocrine Tumors, European Institute of Oncology (IEO), IRCCS, Milan, Italy.
Cecilia C S YeungTranslational Science and Therapeutics Division, Fred Hutchinson Cancer Center and Department of Laboratory Medicine and Pathology, University of Washington, Seattle, Washington, USA.
Jennifer PuliniIncyte Corporation, Wilmington, Delaware, USA.
Mark CornfeldIncyte Corporation, Wilmington, Delaware, USA.
Chuan TianIncyte Corporation, Wilmington, Delaware, USA.
Shailender BhatiaDivision of Medical Oncology, Department of Medicine, University of Washington and Fred Hutchinson Cancer Center, Seattle, Washington, USA.ORCID http://orcid.org/0000-0002-3816-2238

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPOD1UM-201, an open-label, single-arm, phase II multiregional study, evaluated efficacy and tolerability of retifanlimab, a humanized monoclonal antibody targeting programmed cell death protein-1 (PD-1) in chemotherapy-naive patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).

methodsPatients were enrolled across 34 sites in the USA, Canada, and Europe. Eligible patients were ≥18 years with confirmed recurrent advanced locoregional or metastatic MCC not amenable to surgery or radiation therapy, had not received previous systemic treatment, had measurable disease, and Eastern Cooperative Oncology Group performance status 0-1. Retifanlimab 500 mg was administered intravenously every 4 weeks (Q4W) for up to 2 years. The primary endpoint was objective response rate (ORR). Key secondary endpoints included duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety.

resultsA total of 101 patients were enrolled between February 12, 2019, and June 16, 2021, with a median duration of follow-up for response of 22.2 (range: 1.1-55.3) months. ORR was 54.5% (95% CI: 44.2% to 64.4%; n=55), including 18 patients (17.8%) with complete responses (CRs) and 37 (36.6%) with partial responses (PRs). DCR was 60.4% (95% CI: 50.2% to 70.0%; n=61). Median DOR was not reached (95% CI: 14.0 months to not estimable (NE)) in patients who achieved CR and was 25.3 months (95% CI: 14.2 months to NE) in those with PR. With a median follow-up of 9.3 (range: 0.0-57.1) months, the estimated median PFS was 16.0 months (95% CI: 9.0 months to 32.2). Median OS was not reached with 63% of patients alive at 3 years. The safety profile was representative of the PD-(ligand)1 inhibitor class, with grade 3 immune-related adverse events occurring in 11 patients (10.9%).

conclusionsRetifanlimab 500 mg Q4W led to frequent and durable responses in chemotherapy-naive patients with advanced MCC with an acceptable safety profile. Retifanlimab represents a new immunotherapy option for patients with locally advanced or metastatic MCC. TRIAL REGISTRATION NUMBER: NCT03599713; EudraCT 2018-001627-39.

Indexed as

Antibodies, Monoclonal, HumanizedCarcinoma, Merkel CellImmune Checkpoint InhibitorsNeoplasm Recurrence, LocalSkin NeoplasmsAdultAgedAged, 80 and overFemaleHumansMaleMiddle AgedNeoplasm MetastasisAntibodies, Monoclonal, HumanizedImmune Checkpoint InhibitorsImmune Checkpoint InhibitorMonoclonal antibodySkin Cancer

Identifiers

PMID40796223
PMCPMC12359524

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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.