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REGN5459

Phase 1

Relapsed Multiple Myeloma | Small molecule | Oncology |Regeneron Pharmaceuticals, Inc.|Last Updated: May 4, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment43
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04083534First In Human (FIH) Study of REGN5459 in Adult Patients With Relapsed or Refractory Multiple Myeloma (MM)PHASE1 COMPLETED 43 — — Sep 26, 2019May 1, 2025May 4, 20267 United States
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Study Endpoints
Primary Endpoints
Incidence of dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period
Up to 35 Days

Phase 1

Incidence and severity of treatment-emergent adverse events (TEAEs) during REGN5459 treatment period
Up to 12 Weeks After the Last Dose

Phase 1

Incidence and severity of adverse events of special interest (AESI) with REGN5459 treatment period
Up to 12 Weeks After the Last Dose

Phase 1

Objective response rate (ORR) as measured using the International Myeloma Working Group (IMWG) criteria
Up to Approximately 104 Weeks

Phase 2

Secondary Endpoints
Concentrations of REGN5459 in the serum over time
Up to 12 Weeks After the Last Dose
Incidence over time of anti-drug antibodies (ADAs) to REGN5459
Up to 12 Weeks After the Last Dose
Duration of response (DOR) using the IMWG criteria
Up to Approximately 104 Weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
REGN5459EXPERIMENTALCohorts of multiple REGN5459 dose levels
Interventions
NameTypeDescription
REGN5459DRUGAdministered by intravenous (IV) infusion
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites7

Key Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status ≤1 * Patients must have myeloma that is response-evaluable according to the 2016 International Myeloma Working Group (IMWG) response criteria * Measurable disease is defined as 1 or more of the following: 1. S...

Countries:United States
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Competitive Landscape -Multiple Myeloma 228 trials
CompanyTickerTrialsLead PhaseDrugs
Johnson & JohnsonJNJ30PHASE3Daratumumab, Lenalidomide, Bortezomib, Dexamethasone, Cilta-cel
AbbVie, Inc.ABBV16PHASE3Pomalidomide, Dexamethasone, Venetoclax, Etentamig, Carfilzomib
Bristol-Myers Squibb CompanyBMY19PHASE3Mezigdomide, Carfilzomib, Dexamethasone, Daratumumab, Bortezomib
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK5PHASE3IGI, 10%, Clarithromycin, Dexamethasone, Ixazomib, Pomalidomide
GSK plc Sponsored ADRGSK17PHASE3Belantamab mafodotin, Pomalidomide, Dexamethasone, Bortezomib, Daratumumab
Regeneron Pharmaceuticals, Inc.REGN12PHASE3Linvoseltamab, Daratumumab, Carfilzomib, Dexamethasone, Pomalidomide
Pfizer Inc.PFE12PHASE3Elranatamab, Lenalidomide, Elotuzumab, Pomalidomide, Dexamethasone
Sanofi SA Sponsored ADRSNY18PHASE3Isatuximab, Dexamethasone, Pomalidomide, Montelukast, Paracetamol / Acetaminophen
AstraZeneca PLCAZN5PHASE3AZD0120, Daratumumab, Carfilzomib, Dexamethasone, Bortezomib
Gilead Sciences, Inc.GILD3PHASE3Anitocabtagene Autoleucel, Cyclophosphamide, Fludarabine, Pomalidomide, Bortezomib
Karyopharm Therapeutics, Inc.KPTI6PHASE3Selinexor, Elotuzumab, Pomalidomide, Dexamethasone, Bortezomib
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
BioLineRX Ltd. Sponsored ADRBLRX1PHASE3BL-8040 /kg + G-CSF
C4 Therapeutics, Inc.CCCC3PHASE2Cemsidomide, Dexamethasone, cemsidomide, Elranatamab
Cellectar Biosciences, Inc.CLRB1PHASE2Iopofosine I 131 single dose, Iopofosine I 131 fractionated dose
GeoVax Labs, Inc.GOVX1PHASE2COVID-19 Vaccine, Synthetic MVA-based SARS-CoV-2 Vaccine GEO-CM04S1
Autolus Therapeutics Plc Sponsored ADRAUTL1PHASE2AUTO CAR T cell therapy
Incyte CorporationINCY2PHASE1Ruxolitinib, Lenalidomide, Methylprednisolone
Eli Lilly and CompanyLLY1PHASE1LOXO-338, Pirtobrutinib
Moderna, Inc.MRNA2PHASE1mRNA-2808
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Recent Changes (Last 90 Days)
MEDIUMJun 4, 2026NCT04083534TRIAL_REMOVED: changed
MEDIUMJun 4, 2026NCT04083534TRIAL_REMOVED: changed
MEDIUMJun 4, 2026NCT04083534TRIAL_REMOVED: changed
MEDIUMJun 4, 2026NCT04083534TRIAL_REMOVED: changed
MEDIUMJun 4, 2026NCT04083534TRIAL_REMOVED: changed