Evidence map›Paper›PMID 40434509›Full record

Trial reportInternational journal of clinical oncology2025

Efficacy and safety of epcoritamab in Japanese patients with relapsed or refractory diffuse large B-cell lymphoma: 3-year follow-up from the EPCORE NHL-3 trial.

Koji Izutsu, Takahiro Kumode, Junichiro Yuda, Hirokazu Nagai, Yuko Mishima, Youko Suehiro, Kazuhito Yamamoto, Tomoaki Fujisaki, Kenji Ishitsuka, Kenichi Ishizawa and 10 more

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

Trial report in International journal of clinical oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04542824 (Safety and Preliminary Efficacy of Epcoritamab), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–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.

NCT04542824 phase1 / phase2active not recruitingnot on this map

Safety and Preliminary Efficacy of Epcoritamab (GEN3013; DuoBody®-CD3×CD20) in Japanese Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma - A Phase 1/2, Open-Label, Dose-Escalation Trial With Expansion Cohorts

TypeinterventionalSponsorGenmabRan2020 to 2027Enrolled78ConditionsDiffuse Large B Cell Lymphoma, High-grade B-cell Lymphoma, Primary Mediastinal Large B Cell Lymphoma, Follicular LymphomaArmsEpcoritamab (monotherapy), Epcoritamab, Rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone, Gemcitabine and oxaliplatin, Epcoritamab (maintenance)
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Review
  6. Review
  7. Article
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

20 authors.

Koji IzutsuDepartment of Hematology, National Cancer Center Hospital, Tsukiji 5-1-1, Chuo-ku, Tokyo, 104-0045, Japan. kizutsu@ncc.go.jp.ORCID http://orcid.org/0000-0001-9129-8057
Takahiro KumodeDepartment of Hematology and Rheumatology, Kindai University, Osaka, Japan.
Junichiro YudaDepartments of Hematology and Experimental Therapeutics, Office for the Promotion of Hematological Treatment Development, National Cancer Center Hospital East, Kashiwa, Japan.
Hirokazu NagaiDepartment of Hematology, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
Yuko MishimaDepartment of Hematology Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.
Youko SuehiroDepartment of Hematology and Cell Therapy, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
Kazuhito YamamotoDepartment of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan.ORCID http://orcid.org/0000-0002-8588-8955
Tomoaki FujisakiDepartment of Hematology, Japan Red Cross Society, Matsuyama Red Cross Hospital, Matsuyama, Japan.
Kenji IshitsukaDepartment of Hematology and Rheumatology, Kagoshima University, Kagoshima, Japan.
Kenichi IshizawaThird Department of Internal Medicine, Yamagata University, Yamagata, Japan.
Takayuki IkezoeDepartment of Hematology, Fukushima Medical University Hospital, Fukushima, Japan.
Momoko NishikoriDepartment of Hematology, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Daigo AkahaneDepartment of Hematology, Tokyo Medical University, Tokyo, Japan.
Jiro FujitaDepartment of Hematology and Oncology, Graduate School of Medicine, Osaka University, Osaka, Japan.
Pegah JafarinasabianAbbVie, North Chicago, IL, USA.
David SoongGenmab, Plainsboro, NJ, USA.
Barbara D'Angelo MånssonGenmab, Copenhagen, Denmark.
Ami TakahashiGenmab, Tokyo, Japan.
Elena FavaroGenmab, Copenhagen, Denmark.
Noriko FukuharaDepartment of Hematology, Tohoku University, Sendai, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPrimary results from the EPCORE NHL-3 trial (NCT04542824) showed deep, durable responses in Japanese patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) treated with single-agent epcoritamab, a subcutaneous CD3xCD20 bispecific antibody. Here, we report 3-year follow-up of safety and efficacy.

methodsJapanese patients with R/R CD20

resultsAs of July 12, 2024, 36 patients received epcoritamab (median follow-up, 36.7 months). Overall/complete response rates were 56%/47%. Median duration of response was 15.2 months. Median duration of complete response was not reached; an estimated 53% of complete responders remained in complete response at 3 years. Median progression-free/overall survival (PFS/OS) were 4.1/14.9 months overall; neither was reached among complete responders. Three-year PFS/OS estimates were 25%/39% overall and 53%/71% in complete responders. Among 30 evaluable patients, 17 (57%) became minimal residual disease (MRD) negative, which was associated with longer PFS (cycle 3 day 1 landmark analysis). The most common treatment-emergent adverse events (TEAEs) were cytokine release syndrome (83%), injection-site reaction (69%), and neutropenia (39%), consistent with previous reports. No fatal TEAEs occurred.

conclusionsWith  > 3 years of follow-up, epcoritamab treatment has consistently shown durable responses and high rates of MRD negativity in Japanese patients with R/R DLBCL. Safety was similar to previous reports. These long-term remissions reaffirm encouraging outcomes with epcoritamab for this challenging-to-treat population.

Indexed as

Antibodies, BispecificLymphoma, Large B-Cell, DiffuseNeoplasm Recurrence, LocalAdultAgedAged, 80 and overEast Asian PeopleFemaleFollow-Up StudiesHumansJapanMaleMiddle AgedTreatment OutcomeAntibodies, BispecificB-cell lymphomaBispecific antibodiesClinical trialNon-Hodgkin lymphoma

Identifiers

PMID40434509
PMCPMC12296760

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.