Linvoseltamab

Phase 3Monoclonal antibody

Regeneron

Linvoseltamab is one of 87 small molecule programs targeting Monoclonal Gammopathy. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Monoclonal GammopathyActive, not recruiting

AL AmyloidosisActive, not recruiting

Food AllergyActive, not recruiting

Plasma Cell NeoplasmActive, not recruiting

Multiple MyelomaRecruiting

Relapsed/refractory Multiple MyelomaRecruiting

Relapsed/refractoryRecruiting

Relapsed Refractory Multiple Myeloma (RRMM)Recruiting

Relapsed And/or Refractory Multiple MyelomaRecruiting

High Risk Smoldering Multiple Myeloma (HR-SMM)Recruiting

Monoclonal GammopathyPhase 2

Active, not recruiting

AL AmyloidosisPhase 1

Active, not recruiting

Food AllergyPhase 1

Active, not recruiting

Plasma Cell NeoplasmPreclinical

Active, not recruiting

Multiple MyelomaPhase 1

Recruiting

Relapsed/refractory Multiple MyelomaPreclinical

Recruiting

Relapsed/refractoryPreclinical

Recruiting

Relapsed Refractory Multiple Myeloma (RRMM)Preclinical

Recruiting

Relapsed And/or Refractory Multiple MyelomaPhase 3

Recruiting

High Risk Smoldering Multiple Myeloma (HR-SMM)Phase 3

Recruiting

Competition

Competitive Landscape

1135 competitors in Multiple Myeloma

#DrugCompanyPhaseTrials

Linvoseltamab

Regeneron

Phase 3

9 2

Ninlaro

Takeda

Preclinical

18 3

Eliquis

Bristol-Myers Squibb

Preclinical

3 4

Epogen

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Preclinical

2 5

Nolvadex

AstraZeneca

Preclinical

1 6

Systemic Therapy

Bristol-Myers Squibb

Preclinical

1 7

Abecma

Bristol-Myers Squibb

Preclinical

4 8

Oblimersen Sodium

NNational Cancer Institute (NCI)

Preclinical

2 9

Chemotherapy Drug

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Preclinical

1 10

Florbetaben

LLife Molecular Imaging GmbH

Preclinical

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

Timeline

Expected Milestones

Q3 2027

Phase 1Active, not recruiting

Food Allergy

NCT06369467

Q2 2028

Phase 1/2Recruiting

Multiple Myeloma

NCT07181941

Q1 2029

Phase 2Not yet recruiting

Bispecific Antibody

NCT07009899

Q3 2029

Phase 2Recruiting

Multiple Myeloma

NCT06376526

Clinical

Trials by Indication[1]

Multiple Myeloma9 trials

A Proof-of-Concept Trial to Study the Safety and Activity of Linvoseltamab in Participants With Smoldering Multiple Myeloma at High Risk of Developing Multiple Myeloma

Active, not recruiting· Regeneron logo

Regeneron·Phase 2·NCT05955508·40 enrolled

A Study of Linvo-VR vs DVRd in Transplant-Eligible Adult Participants With Newly Diagnosed Multiple Myeloma (NDMM)

Not yet recruiting· Regeneron logo

Regeneron·Phase 2/3·NCT07428369·1,570 enrolled

Phase 1/2 Study of Linvoseltamab in Adult Patients With Relapsed or Refractory Multiple Myeloma

Recruiting· Regeneron logo

Regeneron·Phase 1/2·NCT03761108·387 enrolled

Show 6 more trials

Response-Based Dose Reduction of Linvoseltamab in the Treatment of Relapsed, Refractory, or Triple-Class Relapsed/Refractory Multiple Myeloma

Recruiting·FFred Hutchinson Cancer Center·Phase 1/2·NCT07181941·30 enrolled

IMMUNOPLANT for Newly Diagnosed Multiple Myeloma

Recruiting·—·Phase 2·NCT06376526·28 enrolled

A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma

Recruiting· Regeneron logo

Regeneron·Phase 3·NCT05730036·410 enrolled

A Study to Learn How Safe and How Well Linvoseltamab Works Compared to Standard Treatment in Adult Patients With Multiple Myeloma Who Are Not Eligible for Transplant

Recruiting·EEuropean Myeloma Network B.V.·Phase 3·NCT06932562·1,000 enrolled

A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment

Recruiting· Regeneron logo

Regeneron·Phase 1/2·NCT05828511·149 enrolled

Phase 1b Study of REGN5458 (Anti-BCMA x Anti-CD3 Bispecific Antibody) Plus Other Cancer Treatments for Patients With Relapsed/Refractory Multiple Myeloma

Recruiting· Regeneron logo

Regeneron·Phase 1·NCT05137054·317 enrolled

Bispecific Antibody1 trial

BCMA Bispecific Antibody Therapy for Post-BCMA CAR T-Cell Therapy Relapse (RECLAIM)

Not yet recruiting·MMedical College of Wisconsin·Phase 2·NCT07009899·34 enrolled

Maintenance Therapy1 trial

Linvoseltamab in Addition to Lenalidomide (L2) During Maintenance Therapy of NDMM to Deepen Responses or Redrive MRD Negativity After Relapse

Recruiting·—·Phase 2·NCT06910124·32 enrolled

Relapsed Refractory Multiple Myeloma (RRMM)1 trial

A FIH Phase 1/2 Study to Assess Safety, Tolerability, and Preliminary Anti-Tumor Activity of REGN17372, an Anti-GPRC5D x Anti-CD28 Costimulatory Bispecific Monoclonal Antibody, in Combination With Linvoseltamab, an Anti-BCMA x Anti-CD3 Bispecific Monoclonal Antibody, in Participants With Relapsed/Refractory Multiple Myeloma

Recruiting· Regeneron logo

Regeneron·Preclinical·NCT07455851·150 enrolled

Monoclonal Gammopathy1 trial

Phase 2 Dose-Ranging and Interception Study of Linvoseltamab in Patients With High-Risk Monoclonal Gammopathy of Undetermined Significance or Non-High-Risk Smoldering Multiple Myeloma

Recruiting· Regeneron logo

Regeneron·Phase 2·NCT06140524·116 enrolled

5 more indications

High Risk Smoldering Multiple Myeloma (HR-SMM)1 trial

A Phase 3, Randomized, Open-Label Study of Linvoseltamab Versus Daratumumab in Participants With Smoldering Multiple Myeloma at High Risk of Developing Multiple Myeloma

Recruiting· Regeneron logo

Regeneron·Phase 3·NCT07393282·270 enrolled

Relapsed and/or Refractory Multiple Myeloma1 trial

An Open-Label, Randomized Phase 3 Study of Linvoseltamab Monotherapy and Linvoseltamab Plus Carfilzomib Versus Standard of Care Combination Regimens in Patients With Relapsed/Refractory Multiple Myeloma

Recruiting· Regeneron logo

Regeneron·Phase 3·NCT07222761·915 enrolled

Food Allergy1 trial

A Phase 1 Dose-Escalation Study in Adults With Severe IgE-Mediated Food Allergy, to Assess the Safety, Tolerability, and Pharmacodynamic Effects of Short-Term Linvoseltamab Treatment, a BCMAxCD3 Bispecific Antibody to Induce T-Cell Killing of IgE Producing Plasma Cells, on Top of Chronic Dupilumab Treatment, to Prevent the Formation of New IgE Producing Plasma Cells

Active, not recruiting· Regeneron logo

Regeneron·Phase 1·NCT06369467·6 enrolled

Relapsed/Refractory1 trial

A Phase 1/2 Study of Linvoseltamab in Patients With Relapsed or Refractory Systemic Light Chain Amyloidosis

Recruiting· Regeneron logo

Regeneron·Preclinical·NCT06292780·220 enrolled

Relapsed/Refractory Multiple Myeloma1 trial

A First-in-Human (FIH) Phase 1/2 Study to Assess Safety, Tolerability, and Preliminary Anti-Tumor Activity of REGN7945, an Anti-CD38 x Anti-CD28 Costimulatory Bispecific Monoclonal Antibody, in Combination With Linvoseltamab, an Anti-BCMA x Anti-CD3 Bispecific Monoclonal Antibody, in Participants With Relapsed/Refractory Multiple Myeloma

Recruiting· Regeneron logo

Regeneron·Preclinical·NCT06669247·186 enrolled

Sources

References

[1]
ClinicalTrials.gov — 18 trial records for Linvoseltamab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Linvoseltamab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Linvoseltamab. 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

Linvoseltamab

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2027

Q2 2028

Q1 2029

Q3 2029

Trials by Indication[1]

Multiple Myeloma9 trials

Bispecific Antibody1 trial

Maintenance Therapy1 trial

Relapsed Refractory Multiple Myeloma (RRMM)1 trial

Monoclonal Gammopathy1 trial

High Risk Smoldering Multiple Myeloma (HR-SMM)1 trial

Relapsed and/or Refractory Multiple Myeloma1 trial

Food Allergy1 trial

Relapsed/Refractory1 trial

Relapsed/Refractory Multiple Myeloma1 trial

References

Drug Info

Quick Facts

Related News