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Linvoseltamab

Phase 3

High Risk Smoldering Multiple Myeloma (HR-SMM) | Small molecule | Oncology |Regeneron Pharmaceuticals, Inc.|Last Updated: Mar 16, 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
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment270
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07393282A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM)PHASE3 NOT YET_RECRUITING 270Mar 25, 2026Jul 22, 2033Mar 16, 2026 -
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Study Endpoints
Primary Endpoints
Clinical Progression Free Survival (PFS) per International Myeloma Working Group (IMWG) criteria
Up to 5 years
Biochemical PFS per IMWG criteria
Up to 5 years
Secondary Endpoints
Achievement of Minimal Residual Disease (MRD) Complete Response (CR) at 10^-5 per IMWG criteria
Up to 3 years
Time to death
Up to 9 years
Achievement of Overall Response Rate (ORR) of Partial Response or better (≥PR) per IMWG criteria
Up to 3 years
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LinvoseltamabEXPERIMENTAL -
DaratumumabACTIVE_COMPARATOR -
Interventions
NameTypeDescription
LinvoseltamabDRUGAdministered per the protocol
DaratumumabDRUGAdministered per the protocol
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Key Inclusion Criteria: 1. Eastern Cooperative Oncology Group performance status score ≤1 2. SMM diagnosis per IMWG criteria as defined in the protocol 3. Meets HR-SMM criteria by 1 of the risk models as defined in the protocol Key Exclusion Criteria: 1. Evidence of myeloma-defining events attrib...

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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07393282primaryCompletionDate: changed
LOWMay 24, 2026NCT07393282studyFirstPostDate: changed