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Brentuximab vedotin

Phase 3

Diffuse Large B-cell Lymphoma | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Apr 20, 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
RandomizedDouble-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment239
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04404283Brentuximab Vedotin Plus Lenalidomide and Rituximab for the Treatment of Relapsed/Refractory DLBCLPHASE3 ACTIVE NOT_RECRUITING 239Aug 20, 2020Dec 31, 2026Apr 20, 2026145 United States, Australia +12
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Study Endpoints
Primary Endpoints
Overall survival (OS)
Approximately 2 years

OS is defined as the time from the date of randomization to date of death due to any cause

Secondary Endpoints
Progression-free survival (PFS)
Approximately 1 year
Objective response rate (ORR)
Approximately 1 year
Complete response (CR) rate
Approximately 1 year
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Experimental ArmEXPERIMENTALBrentuximab vedotin + lenalidomide + rituximab
Control ArmACTIVE_COMPARATORPlacebo + lenalidomide + rituximab
Interventions
NameTypeDescription
Brentuximab vedotinDRUG1.2 mg/kg administered into the vein (IV; intravenously) infusion every 3 weeks
RituximabDRUG375 mg/m\^2 administered via intravenous infusion on Cycle 1 Day 1. 1400 mg injected under the skin (subcutaneous) permitted every 3 weeks from Cycle 2 Day 1 through end of treatment.
LenalidomideDRUG20 mg given by mouth (orally) daily
PlaceboOTHERAdministered via intravenous infusion every 3 weeks
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites145

Inclusion Criteria: * Participants with relapsed or refractory diffuse and transformed large B-cell lymphoma (R/R DLBCL). DLBCL and cell of origin (GCB versus non-GCB) will be histologically determined by local pathology assessment for the purposes of study eligibility and stratification. * Partici...

Countries:United StatesAustraliaBelgiumCanadaCzechiaDenmarkFranceItalyPolandSouth KoreaSpainSwitzerlandTaiwanUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT04404283Enrollment: 238 → 239
LOWMay 24, 2026NCT04404283studyFirstPostDate: changed