Evidence map›Paper›PMID 35421228›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2022

Pembrolizumab Monotherapy for Previously Untreated Advanced Hepatocellular Carcinoma: Data from the Open-Label, Phase II KEYNOTE-224 Trial.

Gontran Verset, Ivan Borbath, Mark Karwal, Chris Verslype, Hans Van Vlierberghe, Adel Kardosh, Vittorina Zagonel, Per Stal, Debashis Sarker, Daniel H Palmer and 16 more

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

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02702414 (A Phase 2 Study of Pembrolizumab), which is not on this map. Cited by 71 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
71citing papers in PubMed, 4 pooled it
10.9field-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.

NCT02702414 phase2completednot on this map

A Phase 2 Study of Pembrolizumab (MK-3475) as Monotherapy in Subjects With Advanced Hepatocellular Carcinoma (KEYNOTE-224)

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2016 to 2023Enrolled156ConditionsHepatocellular CarcinomaArmsPembrolizumab
3 · Its place in the literature

Who cites it

71 citing papers in PubMed, 4 syntheses or guidelines pooled it, 82 citations in OpenAlex.

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11 more citing papers are in PubMed but not listed here.

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

26 authors at 20 institutions in 12 countries.

Gontran VersetGastrointestinal Oncology Unit, Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium.
Ivan BorbathCliniques Universitaires Saint-Luc and Université Catholique de Louvain, Brussels, Belgium.
Mark KarwalUniversity of Iowa, Iowa City, Iowa.
Chris VerslypeDigestive Oncology, Department of Oncology, University Hospital Leuven, Belgium.
Hans Van VlierbergheGhent University, Ghent, Belgium.ORCID 0000-0003-0647-9238
Adel KardoshOregon Health & Science University, Knight Cancer Institute, Portland, Oregon.ORCID 0000-0002-6241-4896
Vittorina ZagonelOncology Unit 1, Istituto Oncologico Veneto, IOV, IRCCS, Padua, Italy.
Per StalKarolinska Institutet, Stockholm, Sweden.ORCID 0000-0003-2915-1964
Debashis SarkerSchool of Cancer and Pharmaceutical Sciences, King's College London, London, United Kingdom.
Daniel H PalmerCancer Research UK Liverpool Experimental Cancer Medicine Centre, University of Liverpool, Liverpool, United Kingdom.
Arndt VogelDepartment of Gastroenterology, Hepatology, and Endocrinology, Medizinische Hochschule, Hannover, Germany.ORCID 0000-0003-0560-5538
Julien EdelineDepartment of Medical Oncology, Centre Eugène Marquis, Rennes, France.ORCID 0000-0002-8289-7741
Stephane CattanDepartment of Medical Oncology and Gastroenterology, Hôpital Claude Huriez, Centre Hospitalier Régional Universitaire de Lille, Lille, France.
Masatoshi KudoDepartment of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka, Japan.ORCID 0000-0002-4102-3474
Ann-Lii ChengDepartment of Medical Oncology, National Taiwan University Cancer Center, and Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan.ORCID 0000-0002-9152-6512
Sadahisa OgasawaraDepartment of Gastroenterology, Graduate School of Medicine, Chiba University, Chiba, Japan.
Bruno DanieleOncology Unit, Ospedale del Mare, Napoli, Italy.
Stephen L ChanDepartment of Clinical Oncology, State Key Laboratory of Translational Oncology, The Chinese University of Hong Kong, Shatin, Hong Kong.
Jennifer J KnoxDepartment of Medical Oncology, Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario, Canada.
Shukui QinCancer Centre of Jinling Hospital, Nanjing University of Chinese Medicine, Nanjing, China.
Abby B SiegelMerck & Co., Inc., Kenilworth, New Jersey.
Michael ChisamoreMerck & Co., Inc., Kenilworth, New Jersey.
Ken HatogaiMerck & Co., Inc., Kenilworth, New Jersey.ORCID 0000-0001-7888-7965
Anran WangMerck & Co., Inc., Kenilworth, New Jersey.
Richard S Finn *Department of Medicine, University of California, Los Angeles, California.ORCID 0000-0003-2494-2126
Andrew X Zhu *Massachusetts General Hospital Cancer Center and Department of Medicine, Harvard Medical School, Boston, Massachusetts.ORCID 0000-0003-4873-5033
Rare Breeds Survival Trust · GBCentre Eugène Marquis · FRChiba University · JPChinese University of Hong Kong · HKCliniques Universitaires Saint-Luc · BEHôpital Claude Huriez · FRIstituto Oncologico Veneto · ITKindai University Hospital · JPKing's College London · GBKU Leuven · BEMassachusetts General Hospital · USMedizinische Hochschule Hannover · DENanjing University of Chinese Medicine · CNNational Taiwan University Hospital · TWOregon Health & Science University · USOspedale D. Cotugno · ITPrincess Margaret Cancer Centre · CASvenska Örtmedicinska Institute · SEUniversité Libre de Bruxelles · BEUniversity College Ghent · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeKEYNOTE-224 cohort 1 demonstrated that pembrolizumab was efficacious and tolerable in patients with advanced hepatocellular carcinoma (HCC) previously treated with sorafenib. We report results from KEYNOTE-224 (NCT02702414) cohort 2, which enrolled patients with advanced HCC and no prior systemic therapy. PATIENTS AND

methodsKEYNOTE-224 was an open-label, multicountry phase II trial. Eligible patients in cohort 2 had advanced HCC not amenable or refractory to locoregional therapy and not previously treated with systemic therapy. Patients received pembrolizumab 200 mg intravenously every 3 weeks for ≤2 years. Primary endpoint was objective response rate (ORR) by central imaging review per RECIST v1.1. Secondary endpoints included duration of response (DOR), disease control rate (DCR), time to progression (TTP), progression-free survival (PFS), overall survival (OS), and safety/tolerability.

resultsBetween September 4, 2018, and February 20, 2019, 51 patients were allocated in cohort 2. The median time from the first dose to data cutoff (January 19, 2021) was 27 months (range, 23-29). ORR was 16% [95% confidence interval (CI), 7-29] and was similar across key subgroups. Median DOR was 16 months (range, 3-24+), and DCR was 57%. The median PFS was 4 months (95% CI, 2-8), and median TTP was 4 months (95% CI, 3-9). Median OS was 17 months (95% CI, 8-23). Grade ≥3 treatment-related adverse events occurred in 16% of patients.

conclusionsIn patients with advanced HCC with no prior systemic therapy, pembrolizumab provided durable antitumor activity, promising OS, and had a safety profile consistent with previous observations. These findings support further evaluation of pembrolizumab-based regimens for HCC.

Indexed as

Antibodies, Monoclonal, HumanizedCarcinoma, HepatocellularLiver NeoplasmsHumansAntibodies, Monoclonal, Humanizedpembrolizumab

Identifiers

PMID35421228
PMCPMC9784157
OpenAlexW4224035803

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.