Evidence map›Paper›PMID 40097657›Full record

Trial reportNature cancer2025

Odronextamab monotherapy in patients with relapsed/refractory diffuse large B cell lymphoma: primary efficacy and safety analysis in phase 2 ELM-2 trial.

Won Seog Kim, Tae Min Kim, Seok-Goo Cho, Isidro Jarque, Elżbieta Iskierka-Jażdżewska, Li Mei Poon, H Miles Prince, Huilai Zhang, Junning Cao, Mingzhi Zhang and 16 more

Erratum issued Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Nature cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03888105 (An Open-Label Study to Assess the Anti-Tumor Activity and Safety of REGN1979, an Anti-CD20 x Anti-CD3 Bispecific Antibody, in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma), which is not on this map. Cited by 38 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 4 pooled it
–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.

NCT03888105 phase2active not recruitingnot on this map

An Open-Label Study to Assess the Anti-Tumor Activity and Safety of REGN1979, an Anti-CD20 x Anti-CD3 Bispecific Antibody, in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

TypeinterventionalSponsorRegeneron PharmaceuticalsRan2019 to 2028Enrolled515ConditionsB-cell Non-Hodgkin Lymphoma (B-NHL)ArmsOdronextamab
3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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  4. SEOM-GOTEL clinical guidelines on diffuse large B-cell lymphoma (update 2025).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

26 authors.

Won Seog KimSungkyunkwan University School of Medicine, Samsung Medical Center Division of Hematology-Oncology, Seoul, South Korea. wskimsmc@gmail.com.ORCID http://orcid.org/0000-0002-5400-0466
Tae Min KimSeoul National University Hospital, Seoul National University Cancer Research Institute, Seoul, South Korea.ORCID http://orcid.org/0000-0001-6145-4426
Seok-Goo ChoSeoul St. Mary's Hospital, The Catholic University of Korea, Seoul, South Korea.
Isidro JarqueHematology Department, Hospital Universitari i Politècnic La Fe, Centro de Investigación Biomédica en Red de Cáncer-CIBERONC, Valencia, Spain.
Elżbieta Iskierka-JażdżewskaCopernicus Memorial Hospital, Department of General Hematology, Medical University of Łódź, Łódź, Poland.
Li Mei PoonDepartment of Haematology-Oncology, National University Cancer Institute, National University Hospital, Singapore, Singapore.
H Miles PrinceEpworth HealthCare and University of Melbourne, Melbourne, Victoria, Australia.ORCID http://orcid.org/0000-0002-0058-2448
Huilai ZhangDepartment of Lymphoma, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin, China.
Junning CaoFudan University Shanghai Cancer Center, Shanghai, China.
Mingzhi ZhangDepartment of Oncology, First Affiliated Hospital, Zhengzhou University, Zhengzhou, China.
Benoît TessoulinHematology Department, Nantes University Hospital, Nantes, France.
Sung Yong OhDong-A University Hospital, Busan, South Korea.
Francesca LimSingapore General Hospital, Singapore, Singapore.
Cecilia CarpioDepartment of Hematology, Vall d'Hebron Institute of Oncology (VHIO), University Hospital Vall d'Hebron, Autonomous University of Barcelona (UAB), Barcelona, Spain.
Tran-Der TanHematology and Medical Oncology, Koo Foundation Sun Yat Sen Cancer Center, Taipei City, Taiwan.
Sabarish AyyappanUniversity of Iowa Hospital and Clinics, Iowa City, IA, USA.
Antonio GutierrezDepartment of Hematology, Hospital Universitario Son Espases, IdISBa, Palma, Spain.
Jingxian CaiRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Melanie UfkinRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Saleem ShariffRegeneron UK, Ltd., Uxbridge, UK.
Jurriaan Brouwer-VisserRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Aafia ChaudhryRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Hesham MohamedRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Srikanth AmbatiRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Jan WalewskiNarodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy, Warszawa, Poland.
ELM-2 Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The phase 2, multicohort, ongoing ELM-2 study evaluates odronextamab, a CD20×CD3 bispecific antibody, in patients with relapsed/refractory (R/R) B cell non-Hodgkin lymphoma after ≥2 lines of therapy. Here primary analysis of the diffuse large B cell lymphoma (DLBCL) cohort is reported. Patients received intravenous odronextamab in 21-day cycles until progression or unacceptable toxicity, with cycle 1 step-up dosing to mitigate cytokine release syndrome (CRS) risk. The primary endpoint was objective response rate (ORR). Secondary endpoints included complete response (CR) rate, duration of response, progression-free survival (PFS) and overall survival. A total of 127 patients were enrolled. At the 29.9-month efficacy follow-up, the ORR was 52.0% and CR rate was 31.5%. Median durations of response and CR were 10.2 and 17.9 months, respectively. Undetectable minimal residual disease at cycle 4 day 15 was associated with PFS benefit. With a step-up of 0.7 to 4 to 20 mg (n = 60), CRS was the most common treatment-emergent adverse event (53.3% (grade ≥3, 1.7%)). No immune effector cell-associated neurotoxicity syndrome was reported. Infections were reported in 82/127 (64.6%) patients (grade ≥3, 38.6%; coronavirus disease 2019, 18.1% (grade ≥3, 12.6%)). In conclusion, odronextamab showed encouraging efficacy in heavily pretreated R/R DLBCL and generally manageable safety with supportive care. Clinical trial registration: NCT03888105 .

Indexed as

Antibodies, BispecificLymphoma, Large B-Cell, DiffuseNeoplasm Recurrence, LocalAdultAgedAged, 80 and overFemaleHumansMaleMiddle AgedProgression-Free SurvivalTreatment OutcomeYoung AdultAntibodies, Bispecific

Identifiers

PMID40097657
PMCPMC12003196

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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.