Evidence map›Paper›PMID 36548927›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2023

Epcoritamab, a Novel, Subcutaneous CD3xCD20 Bispecific T-Cell-Engaging Antibody, in Relapsed or Refractory Large B-Cell Lymphoma: Dose Expansion in a Phase I/II Trial.

Catherine Thieblemont, Tycel Phillips, Herve Ghesquieres, Chan Y Cheah, Michael Roost Clausen, David Cunningham, Young Rok Do, Tatyana Feldman, Robin Gasiorowski, Wojciech Jurczak and 13 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIClinical Trial, Phase I
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03625037 (A Phase 1/2, Open-label Safety Trial of GEN3013 in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma), which is not on this map. Cited by 351 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
351citing papers in PubMed, 7 pooled it
48.2field-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.

NCT03625037 phase1 / phase2active not recruitingnot on this map

A Phase 1/2, Open-label Safety Trial of GEN3013 in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma

TypeinterventionalSponsorGenmabRan2018 to 2029Enrolled666ConditionsDLBCL, High-grade B-cell Lymphoma (HGBCL), Primary Mediastinal Large B-cell Lymphoma (PMBCL), FLArmsEpcoritamab
3 · Its place in the literature

Who cites it

351 citing papers in PubMed, 7 syntheses or guidelines pooled it, 494 citations in OpenAlex.

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

23 authors at 19 institutions in 9 countries.

Catherine ThieblemontAssistance Publique & Hôpitaux de Paris (APHP), Hôpital Saint-Louis, Hémato-oncologie, Université de Paris, Paris, France.ORCID 0000-0002-9941-2448
Tycel PhillipsUniversity of Michigan Comprehensive Cancer Center, Ann Arbor, MI.ORCID 0000-0003-2143-9672
Herve GhesquieresHospices Civils de Lyon, Centre Hospitalier Lyon Sud, Pierre-Bénite, France.ORCID 0000-0002-3131-3718
Chan Y CheahSir Charles Gairdner Hospital, Perth, Australia.ORCID 0000-0001-7988-1565
Michael Roost ClausenVejle Hospital, Vejle, Denmark.ORCID 0000-0003-3218-3633
David CunninghamThe Royal Marsden NHS Foundation Trust, Sutton, United Kingdom.ORCID 0000-0001-5158-1069
Young Rok DoKeimyung University Dongsan Medical Center, Daegu, Republic of Korea.
Tatyana FeldmanHackensack Meridian Health Hackensack University Medical Center, Hackensack, NJ.
Robin GasiorowskiConcord Hospital, University of Sydney, Sydney, Australia.ORCID 0000-0003-1225-8757
Wojciech JurczakMSC National Research Institute of Oncology, Kraków, Poland.
Tae Min KimSeoul National University Hospital, Seoul, Republic of Korea.ORCID 0000-0001-6145-4426
David John LewisUniversity Hospitals Plymouth NHS Trust, Derriford Hospital, Plymouth, United Kingdom.ORCID 0000-0001-5903-3788
Marjolein van der PoelOn behalf of the Lunenburg Lymphoma Phase I/II Consortium-HOVON/LLPC, Maastricht, Department of Internal Medicine, Division of Hematology, GROW School for Oncology and Developmental Biology, Maastricht University Medical Center, Maastricht, the Netherlands.
Michelle Limei PoonNational University Hospital, Singapore.
Mariana Cota StirnerAbbVie, North Chicago, IL.
Nurgul KilavuzGenmab, Princeton, NJ.
Christopher ChiuGenmab, Princeton, NJ.ORCID 0000-0001-9744-991X
Menghui ChenGenmab, Princeton, NJ.
Mariana SacchiGenmab, Princeton, NJ.
Brian ElliottGenmab, Princeton, NJ.
Tahamtan AhmadiGenmab, Princeton, NJ.
Martin HutchingsRigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.ORCID 0000-0003-3873-1741
Pieternella J LugtenburgOn behalf of the Lunenburg Lymphoma Phase I/II Consortium-HOVON/LLPC, Erasmus MC Cancer Institute, University Medical Center, Department of Hematology, Rotterdam, the Netherlands.ORCID 0000-0002-6735-8651
Genmab (United States) · USAbbVie (United States) · USCopenhagen University Hospital · DKDerriford Hospital · GBErasmus MC Cancer Institute · NLHackensack University Medical Center · USHospices Civils de Lyon · FRKeimyung University Dongsan Medical Center · KRMaastricht University · NLNational University Hospital · SGPrinceton University · USRoyal Marsden NHS Foundation Trust · GBSeoul National University Hospital · KRThe Maria Sklodowska-Curie National Research Institute of Oncology · PLThe University of Sydney · AUThe University of Western Australia · AUUniversité Paris Cité · FRUniversity of Michigan · USVejle Sygehus · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeEpcoritamab is a subcutaneously administered CD3xCD20 T-cell-engaging, bispecific antibody that activates T cells, directing them to kill malignant CD20 PATIENTS AND

methodsIn the dose-expansion cohort of a phase I/II study (ClinicalTrials.gov identifier: NCT03625037), adults with relapsed or refractory CD20

resultsAs of January 31, 2022, 157 patients were treated (median age, 64 years [range, 20-83]; median of three [range, 2-11] prior therapy lines; primary refractory disease: 61.1%; prior chimeric antigen receptor (CAR) T-cell exposure: 38.9%). At a median follow-up of 10.7 months, the overall response rate was 63.1% (95% CI, 55.0 to 70.6) and the complete response rate was 38.9% (95% CI, 31.2 to 46.9). The median duration of response was 12.0 months (among complete responders: not reached). Overall and complete response rates were similar across key prespecified subgroups. The most common treatment-emergent adverse events were cytokine release syndrome (49.7%; grade 1 or 2: 47.1%; grade 3: 2.5%), pyrexia (23.6%), and fatigue (22.9%). Immune effector cell-associated neurotoxicity syndrome occurred in 6.4% of patients with one fatal event.

conclusionSubcutaneous epcoritamab resulted in deep and durable responses and manageable safety in highly refractory patients with large B-cell lymphoma, including those with prior CAR T-cell exposure.

Indexed as

Antineoplastic AgentsLymphoma, Large B-Cell, DiffuseReceptors, Chimeric AntigenAdultHumansMiddle AgedNeoplasm Recurrence, LocalNeurotoxicity SyndromesT-LymphocytesAntineoplastic Agentscell-associated neurotoxicityReceptors, Chimeric Antigen

Identifiers

PMID36548927
PMCPMC10115554
OpenAlexW4312115076

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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.