Linvoseltamab

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

Multiple MyelomaRelapsed/refractoryMaintenance TherapyRecurrent Multiple MyelomaRelapsed/refractory Multiple MyelomaPlasma Cell NeoplasmFood AllergyMonoclonal Gammopathy

259 competitors in Multiple Myeloma

#DrugCompanyPhaseTrials

1

Fludara

Sanofi

Phase 3

472

TALVEY

Johnson & Johnson

Phase 3

223

Venclexta

AbbVie

Phase 3

174

Xpovio

KKaryopharm Therapeutics Inc

Phase 3

285

Azatiq

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Phase 3

226

Vepesid

AAvyxa

Phase 3

177

Elranatamab

Pfizer

Phase 3

268

BLENREP

GGlaxo Dba Glaxosmithkline

Phase 3

119

Platinol

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Phase 3

910

Sylvant

RRECORDATI GROUP

Phase 3

8Show 28 more competitors

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

Timeline

Expected Milestones

Clinical

Trials by Indication[1]

Multiple Myeloma9 trials

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

Not yet recruiting·Regeneron·Phase 2/3·NCT07428369·1,570 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·Phase 1/2·NCT05828511·149 enrolled

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·Phase 2·NCT05955508·40 enrolled

Show 6 more trials

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

Phase 1/2 FIH Study of REGN5458 (Anti-BCMA x Anti-CD3 Bispecific Antibody) in Patients With Relapsed or Refractory Multiple Myeloma

Recruiting·Regeneron·Preclinical·NCT03761108·387 enrolled

Determination 2 - Isatuximab, Iberdomide, Bortezomib and Dexamethasone Induction, Followed by Risk- and Response-Adapted Consolidation and Maintenance Therapy, in Transplant-Eligible Patients With Newly Diagnosed Multiple Myeloma (NDMM)

Recruiting·DDana-Farber Cancer Institute·Phase 3·NCT07624513·720 enrolled

Immuno-consolidation for Newly Diagnosed Multiple Myeloma Using Lack of MRD Negativity After Initial cOmbination Therapy to Pursue Deeper Responses With Linvoseltamab ANd Delay Transplant

Recruiting·DDickran Kazandjian, MD·Phase 2·NCT06376526·150 enrolled

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

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·Phase 1·NCT05137054·317 enrolled

Relapsed Refractory Multiple Myeloma (RRMM)3 trials

A Phase 4, Single-Arm, Multicenter Study of Prophylactic Tocilizumab in Participants With Relapsed/Refractory Multiple Myeloma Treated With Linvoseltamab in the Outpatient Setting

Recruiting·Regeneron·Approved·NCT07609940·30 enrolled

An Open-label, Randomized, Phase 3 Study of Linvoseltamab (REGN5458; Anti- BCMA x Anti-CD3 Bispecific Antibody) Versus the Combination of Elotuzumab, Pomalidomide, and Dexamethasone (EPd), in Patients With Relapsed/Refractory Multiple Myeloma (LINKER-MM3)

Recruiting·Regeneron·Phase 3·NCT05730036·410 enrolled

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·Preclinical·NCT07455851·150 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

Amyloidosis1 trial

An Open-Label, Randomized Phase 3 Trial of Linvoseltamab Compared With Daratumumab, Bortezomib, Cyclophosphamide, and Dexamethasone (Dara-Vcd) in Participants With Newly Diagnosed Systemic Light Chain Amyloidosis

Not yet recruiting·Regeneron·Phase 3·NCT07901725·382 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·Phase 3·NCT07222761·915 enrolled

6 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·Phase 3·NCT07393282·270 enrolled

Recurrent Multiple Myeloma1 trial

Pharmacodynamically Monitored Linvoseltamab Dosing De-Escalation in Relapsed Multiple Myeloma

Recruiting·FFred Hutchinson Cancer Center·Preclinical·NCT07181941·30 enrolled

Relapsed/Refractory1 trial

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

Recruiting·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·Preclinical·NCT06669247·186 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·Phase 2·NCT06140524·116 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·Phase 1·NCT06369467·6 enrolled

Details

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