Evidence map›Paper›PMID 38401247›Full record

Trial reportESMO open2024

A phase II study of retifanlimab, a humanized anti-PD-1 monoclonal antibody, in patients with solid tumors (POD1UM-203).

A M Di Giacomo, M Schenker, J Medioni, S Mandziuk, M Majem, G Gravis, M Cornfeld, S Ranganathan, S Lou, T Csoszi

Open access · goldAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in ESMO open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
2.3field-weighted citation impact, top 11% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 8 citations in OpenAlex.

  1. Trial
  2. 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

10 authors at 7 institutions in 6 countries.

A M Di GiacomoUniversity of Siena, Siena, Italy; Center for Immuno-Oncology, University Hospital of Siena, Siena, Italy.
M SchenkerCentrul de Oncologie Sf. Nectarie, Oncologie Medicala, Craiova, Romania.
J MedioniCentre of Early Clinical Trials in Cancer, Hôpital Européen Georges-Pompidou, Université Paris Cité, Paris, France.
S MandziukDepartment of Clinical Oncology and Chemotherapy, Medical University of Lublin, Lublin, Poland.
M MajemMedical Oncology Department, Hospital de Sant Pau, Barcelona, Spain.
G GravisDepartment of Medical Oncology, Institut Paoli-Calmettes, Aix-Marseille Université, CRCM, Marseille, France.
M CornfeldIncyte Corporation, Wilmington, USA.
S RanganathanIncyte Corporation, Wilmington, USA.
S LouIncyte Corporation, Wilmington, USA.
T CsosziHetényi Géza Kórház Onkológiai Központ, Szolnok, Hungary. Electronic address: dr.cstibor@freemail.hu.
Incyte (United States) · USAix-Marseille Université · FRBM Központi Kórház · HUHospital de Sant Pau · ESMedical University of Lublin · PLUniversité Paris Cité · FRUniversity of Siena · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPOD1UM-203, an open-label, multicenter, phase II study, evaluated retifanlimab, a humanized monoclonal antibody targeting programmed cell death protein-1 (PD-1) in patients with selected solid tumors where immune checkpoint inhibitor therapies have previously shown efficacy. PATIENTS AND

methodsEligible patients (≥18 years) had measurable disease and included unresectable or metastatic melanoma, treatment-naive metastatic non-small-cell lung cancer (NSCLC) with high programmed death-ligand 1 (PD-L1) expression (tumor proportion score ≥50%), cisplatin-ineligible locally advanced/metastatic urothelial carcinoma (UC) with PD-L1 expression (combined positive score ≥10%), or treatment-naive locally advanced/metastatic clear-cell renal cell carcinoma (RCC). Retifanlimab 500 mg was administered intravenously every 4 weeks as a 30-min infusion. The primary endpoint was investigator-assessed overall response rate.

resultsOverall, 121 patients (35 melanoma, 23 NSCLC, 29 UC, 34 RCC) were enrolled and treated. The overall response rate [95% confidence interval (CI)] was 40.0% (23.9-57.9) in the melanoma cohort, 34.8% (16.4-57.3) in the NSCLC cohort, 37.9% (20.7-57.7) in the UC cohort, and 23.5% (10.7-41.2) in the RCC cohort. Median duration of response was 11.5 months (95% CI 2.2-not reached) in the UC cohort, and was not reached in the other cohorts. Retifanlimab safety was consistent with previous experience for PD-(L)1 inhibitors.

conclusionsRetifanlimab demonstrated durable antitumor activity in patients with melanoma, NSCLC, UC, or RCC. The efficacy and safety of retifanlimab were as expected for a PD-(L)1 inhibitor. These data support further study of retifanlimab in solid tumors.

Indexed as

Carcinoma, Non-Small-Cell LungCarcinoma, Renal CellCarcinoma, Transitional CellLung NeoplasmsMelanomaUrinary Bladder NeoplasmsAntibodies, MonoclonalB7-H1 AntigenHumansImmune Checkpoint InhibitorsAntibodies, MonoclonalB7-H1 AntigenImmune Checkpoint Inhibitorscheckpoint inhibitorPD-1 inhibitorphase IIretifanlimabsolid tumor

Identifiers

PMID38401247
PMCPMC10982862
OpenAlexW4392122311

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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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.