Evidence map›Paper›PMID 35816951›Full record

Trial reportESMO open2022

A phase II study of retifanlimab (INCMGA00012) in patients with squamous carcinoma of the anal canal who have progressed following platinum-based chemotherapy (POD1UM-202).

S Rao, G Anandappa, J Capdevila, L Dahan, L Evesque, S Kim, M P Saunders, D C Gilbert, L H Jensen, E Samalin and 12 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in ESMO open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03597295 (A Phase 2 Study of INCMGA00012 in Participants With Squamous Carcinoma of the Anal Canal Who Have Progressed Following Platinum-Based Chemotherapy), which is not on this map. Cited by 51 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
51citing papers in PubMed, 4 pooled it
14.2field-weighted citation impact, top 1% of its field
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.

NCT03597295 phase2completednot on this map

A Phase 2 Study of INCMGA00012 in Participants With Squamous Carcinoma of the Anal Canal Who Have Progressed Following Platinum-Based Chemotherapy (POD1UM-202)

TypeinterventionalSponsorIncyte CorporationRan2018 to 2021Enrolled94ConditionsSquamous Cell Carcinoma of Anal CanalArmsRetifanlimab
3 · Its place in the literature

Who cites it

51 citing papers in PubMed, 4 syntheses or guidelines pooled it, 70 citations in OpenAlex.

  1. SEOM-GEMCAD-TTD clinical guidelines for anal cancer (2025).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Guideline
  2. Improving our understanding of the quality of life of patients with metastatic or recurrent/persistent anal cancer: a systematic review.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025
    Pooled it
  3. Pooled it
  4. Guideline
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
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  11. Review
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  14. Article
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  17. Observational
  18. Efficacy of Immune Checkpoint Inhibitors and Oncoviruses in Solid Tumors.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Review
  19. Article
  20. Review
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

22 authors at 18 institutions in 9 countries.

S RaoThe Royal Marsden, London, UK. Electronic address: Sheela.Rao@rmh.nhs.uk.
G AnandappaThe Royal Marsden, London, UK.
J CapdevilaVall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology (VHIO), Teknon-IOB, Barcelona, Spain.
L DahanHôpital de la Timone, Marseille, France.
L EvesqueDepartment of Medical Oncology, Centre Antoine Lacassagne, Nice, France.
S KimCentre Hospitalier Régional Universitaire de Besançon, Besançon, France.
M P SaundersThe Christie NHS Foundation Trust, Manchester.
D C GilbertSussex Cancer Centre, Royal Sussex County Hospital, Brighton, UK.
L H JensenUniversity Hospital of Southern Denmark, Vejle, Denmark.
E SamalinDepartment of Digestive Oncology, Montpellier Cancer Institute (ICM), Montpellier University, Montpellier, France.
K-L SpindlerAarhus University Hospital, Aarhus, Denmark.
S TamberiDepartment of Oncology/Haematology, AUSL Romagna Oncology Unit Faenza Hospital (RA), Faenza, Italy.
A DemolsDepartment of Gastroenterology and GI Oncology, CUB Hôpital Erasme, Université Libre de Bruxelles, Anderlecht, Belgium.
M G GurenOslo University Hospital and University of Oslo, Oslo, Norway.
D ArnoldAsklepios Tumorzentrum Hamburg, AK Altona, Hamburg, Germany.
M FakihCity of Hope Comprehensive Cancer Center, Duarte, USA.
T KayyalRenovatio Clinical, Houston, USA.
M CornfeldIncyte Corporation, Wilmington, USA.
C TianIncyte Corporation, Wilmington, USA.
M CatlettIncyte Corporation, Wilmington, USA.
M SmithIncyte Corporation, Wilmington, USA.
J-P SpanoAPHP-Sorbonne University-IUC, Paris, France.
Incyte (United States) · USAarhus University Hospital · DKAsklepios Klinik Altona · DECentre Antoine Lacassagne · FRCentre Hospitalier Universitaire de Besançon · FRCity of Hope · USHôpital de la Timone · FROslo University Hospital · NOOspedale per gli Infermi · ITRegion of Southern Denmark · DKRoyal Marsden Hospital · GBRoyal Marsden NHS Foundation Trust · GBRoyal Sussex County Hospital · GBSorbonne Université · FRThe Christie NHS Foundation Trust · GBUniversité de Montpellier · FRUniversité Libre de Bruxelles · BEVall d'Hebron Institute of Oncology · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLocally advanced or metastatic squamous carcinoma of the anal canal (SCAC) has poor prognosis following platinum-based chemotherapy. Retifanlimab (INCMGA00012), a humanized monoclonal antibody targeting programmed death protein-1 (PD-1), demonstrated clinical activity across a range of solid tumors in clinical trials. We present results from POD1UM-202 (NCT03597295), an open-label, single-arm, multicenter, phase II study evaluating retifanlimab in patients with previously treated advanced or metastatic SCAC. PATIENTS AND

methodsPatients ≥18 years of age had measurable disease and had progressed following, or were ineligible for, platinum-based therapy. Retifanlimab 500 mg was administered intravenously every 4 weeks. The primary endpoint was overall response rate (ORR) by independent central review. Secondary endpoints were duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety.

resultsOverall, 94 patients were enrolled. At a median follow-up of 7.1 months (range, 0.9-19.4 months), ORR was 13.8% [95% confidence interval (CI) 7.6% to 22.5%], with one complete response (1.1%) and 12 partial responses (12.8%). Responses were observed regardless of human immunodeficiency virus or human papillomavirus status, programmed death ligand 1 (PD-L1) expression, or liver metastases. Stable disease was observed in 33 patients (35.1%) for a DCR of 48.9% (95% CI 38.5% to 59.5%). Median DOR was 9.5 months (range, 5.6 months-not estimable). Median (95% CI) PFS and OS were 2.3 (1.9-3.6) and 10.1 (7.9-not estimable) months, respectively. Retifanlimab safety in this population was consistent with previous experience for the PD-(L)1 inhibitor class.

conclusionsRetifanlimab demonstrated clinically meaningful and durable antitumor activity, and an acceptable safety profile in patients with previously treated locally advanced or metastatic SCAC who have progressed on or are intolerant to platinum-based chemotherapy.

Indexed as

Carcinoma, Squamous CellPlatinumAnal CanalAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsAnus NeoplasmsHumansImmune Checkpoint InhibitorsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsImmune Checkpoint InhibitorsPlatinumanal cancerclinical trialINCMGA00012PD-(L)1 inhibitorphase IIretifanlimab

Identifiers

PMID35816951
PMCPMC9463376
OpenAlexW4284974088

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.