Odronextamab

Phase 3Monoclonal antibody

Regeneron

Odronextamab is one of 136 small molecule programs targeting B-cell Malignancies. It is currently in Phase 3.

Indications

Total Trials

Active Trials

135

Competitors

Pipeline

Status by Indication[3][1]

Indication

B-Cell MalignanciesCompleted

Recurrent Diffuse Large B-Cell LymphomaRecruiting

B-Cell Non-Hodgkin Lymphoma (b-NHL)Active, not recruiting

Relapsed/refractory Follicular LymphomaRecruiting

AdvancedRecruiting

LymphomaRecruiting

Follicular LymphomaActive, not recruiting

B-Cell MalignanciesPhase 1

Completed

Recurrent Diffuse Large B-Cell LymphomaPhase 2

Recruiting

B-Cell Non-Hodgkin Lymphoma (b-NHL)Phase 2

Active, not recruiting

Relapsed/refractory Follicular LymphomaPhase 3

Recruiting

AdvancedPhase 2

Recruiting

LymphomaPhase 3

Recruiting

Follicular LymphomaPhase 3

Active, not recruiting

Competition

Competitive Landscape

401 competitors in Lymphoma

#DrugCompanyPhaseTrials

Odronextamab

Regeneron

Phase 3

3 2

Zofran

Novartis

Preclinical

2 3

Cabenuva

GSK

Preclinical

1 4

Norvir

AbbVie

Preclinical

1 5

Emend

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

1 6

Kenalog

BBausch Health Americas, Inc.

Preclinical

1 7

Nuvigil

NNuvo Research GmbH

Preclinical

1 8

Elitek

AAzienda U.S.L. 1 di Massa e Carrara

Preclinical

—9

Decadron

QQuince Therapeutics S.p.A.

Preclinical

—10

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

Preclinical

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

Phase 3Recruiting

Lymphoma

NCT06230224

Q4 2027

Phase 1Recruiting

Recurrent Transformed Chronic Lymphocytic Leukemia

NCT06735664

Q1 2028

Phase 2Recruiting

Advanced

NCT07128641

Q4 2028

Phase 2Active, not recruiting

B-Cell Non-Hodgkin Lymphoma (b-NHL)

NCT03888105

Clinical

Trials by Indication[1]

Lymphoma3 trials

A Global Study of Novel Agents in Paediatric and Adolescent Relapsed and Refractory B-cell Non-Hodgkin Lymphoma

Recruiting·UUniversity of Birmingham·Phase 2/3·NCT05991388·210 enrolled

A Trial to Study if REGN5837 in Combination With Odronextamab is Safe for Adult Participants With Aggressive B-cell Non-Hodgkin Lymphomas

Recruiting· Regeneron logo

Regeneron·Phase 1·NCT05685173·91 enrolled

A Trial to Learn How Effective and Safe Odronextamab is Compared to Standard of Care for Adult Participants With Previously Treated Aggressive B-cell Non-Hodgkin Lymphoma

Recruiting· Regeneron logo

Regeneron·Phase 3·NCT06230224·216 enrolled

B-cell Malignancies2 trials

A Study to Learn How Safe and Tolerable Odronextamab and Cemiplimab Are in Adult Patients With B-cell Malignancies

Active, not recruiting· Regeneron logo

Regeneron·Phase 1·NCT02651662·105 enrolled

Study to Investigate the Safety and Tolerability of Odronextamab in Patients With CD20+ B-Cell Malignancies

Completed· Regeneron logo

Regeneron·Phase 1·NCT02290951·200 enrolled

Recurrent Diffuse Large B-Cell Lymphoma2 trials

Odronextamab for Relapsed/Refractory Large B-Cell Lymphomas Before Definitive Lymphoma-Directed Therapies

Recruiting·UUniversity of Washington·Phase 2·NCT06784726·27 enrolled

A Phase 2 Study of Odronextamab in Relapsed/ Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) Before and After Chimeric Antigen Receptor (CAR) T-Cell Therapy

Recruiting·JJoseph Tuscano·Phase 2·NCT06854159·34 enrolled

Advanced1 trial

Odronextamab in Low Tumor Volume Advanced FL

Recruiting·GGottfried von Keudell, MD PhD·Phase 2·NCT07128641·35 enrolled

MPA1 trial

A Compassionate Use (CU) Program of Odronextamab

Available· Regeneron logo

Regeneron··NCT05619367

7 more indications

Follicular Lymphoma1 trial

A Trial to Learn if Odronextamab Combined With Chemotherapy is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Chemotherapy for Adult Participants With Follicular Lymphoma

Active, not recruiting· Regeneron logo

Regeneron·Phase 3·NCT06097364·733 enrolled

Recurrent Transformed Chronic Lymphocytic Leukemia1 trial

A Phase I Study of Covalent BTK Inhibitor Zanubrutinib in Combination With a CD3-CD20 Bispecific Antibody Odronextamab in Patients With Richter's Transformation

Recruiting·CCity of Hope Medical Center·Phase 1·NCT06735664·23 enrolled

Diffuse Large B-cell Lymphoma(DLBCL)1 trial

A Phase 3, Open Label, Randomized Study Comparing the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 × Anti-CD3 Bispecific Antibody, in Combination With CHOP (ODRO-CHOP) Versus Rituximab in Combination With CHOP (R-CHOP) in Previously Untreated Participants With Diffuse Large B-cell Lymphoma (DLBCL) (OLYMPIA-3)

Recruiting· Regeneron logo

Regeneron·Phase 3·NCT06091865·904 enrolled

Lupus Nephritis (LN)1 trial

A Dose Escalation Study Investigating Bispecific Antibody Therapy in Patients With Lupus Nephritis

Recruiting· Regeneron logo

Regeneron·Phase 1·NCT06975787·90 enrolled

Follicular Lymphoma (FL)1 trial

A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 X Anti-CD3 Bispecific Antibody Versus Investigator's Choice in Previously Untreated Participants With Follicular Lymphoma (OLYMPIA-1)

Recruiting· Regeneron logo

Regeneron·Phase 3·NCT06091254·822 enrolled

Relapsed/Refractory Follicular Lymphoma1 trial

A Phase 3, Open Label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 x Anti-CD3 Bispecific Antibody, in Combination With Lenalidomide Versus Rituximab in Combination With Lenalidomide in Relapsed/Refractory Participants With Follicular Lymphoma and Marginal Zone Lymphoma (OLYMPIA-5)

Recruiting· Regeneron logo

Regeneron·Phase 3·NCT06149286·580 enrolled

B-cell Non-Hodgkin Lymphoma (B-NHL)1 trial

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

Active, not recruiting· Regeneron logo

Regeneron·Phase 2·NCT03888105·515 enrolled

Sources

References

[1]
ClinicalTrials.gov — 16 trial records for Odronextamab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Odronextamab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Odronextamab. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Regeneron company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: Regeneron

Odronextamab

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q4 2027

Q1 2028

Q4 2028

Trials by Indication[1]

Lymphoma3 trials

B-cell Malignancies2 trials

Recurrent Diffuse Large B-Cell Lymphoma2 trials

Advanced1 trial

MPA1 trial

Follicular Lymphoma1 trial

Recurrent Transformed Chronic Lymphocytic Leukemia1 trial

Diffuse Large B-cell Lymphoma(DLBCL)1 trial

Lupus Nephritis (LN)1 trial

Follicular Lymphoma (FL)1 trial

Relapsed/Refractory Follicular Lymphoma1 trial

B-cell Non-Hodgkin Lymphoma (B-NHL)1 trial

References

Drug Info

Quick Facts

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