Linvoseltamab

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

Multiple MyelomaRelapsed/refractoryMaintenance TherapyRelapsed/refractory Multiple MyelomaRecurrent Multiple MyelomaPlasma Cell NeoplasmFood AllergyMonoclonal Gammopathy

282 competitors in Multiple Myeloma

#DrugCompanyPhaseTrials

1

Empliciti

Bristol-Myers Squibb

Phase 3

452

Ninlaro

Takeda

Phase 3

183

Venclexta

AbbVie

Phase 3

174

Biaxin

AbbVie

Phase 3

155

Xpovio

KKaryopharm Therapeutics Inc

Phase 3

296

Azatiq

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Phase 3

237

Vepesid

AAvyxa

Phase 3

178

Mozobil

GGenzyme, a Sanofi Company

Phase 3

159

BLENREP

GGlaxo Dba Glaxosmithkline

Phase 3

1010

Sylvant

RRECORDATI GROUP

Phase 3

8Show 27 more competitors

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

Timeline

Expected Milestones

Clinical

Trials by Indication[1]

Multiple Myeloma10 trials

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

Recruiting·Regeneron·Phase 1/2·NCT03761108·387 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·Phase 1/2·NCT05828511·149 enrolled

Show 7 more 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·Phase 2·NCT05955508·40 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·Phase 3·NCT05730036·410 enrolled

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

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)

Not yet 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)2 trials

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

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

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

Recurrent Multiple Myeloma1 trial

Pharmacodynamically Monitored Linvoseltamab Dosing De-Escalation in Relapsed Multiple Myeloma

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

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

5 more indications

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

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

Drug Info

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