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Epcoritamab

Phase 2

Large B Cell Lymphoma | Small molecule | Oncology |Incyte Corporation|Last Updated: Aug 17, 2025

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment80
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07126236Response-adaptive to Epcoritamab In First Relapse: Study to Evaluate the Efficacy of Eptoritamab in Patients With Relapse/Refractory Large B Cell LymphomaPHASE2 RECRUITING 80Aug 4, 2025Dec 1, 2031Aug 17, 202515 Spain
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Study Endpoints
Primary Endpoints
Efficacy of Epcoritamab monotherapy
Cycle 3, cycle 4, cycle 7, cycle 10, cycle 13 (for combination therapy) and EoT (28 days after last administration of investigational product) visits. Each cycle is 28 days.

The efficacy of Epcoritamab monotherapy will be centrally evaluated by the best CRR at any moment since initiation. The CRR will be assessed by PET-CT according to Lugano Classification and is defined as the proportion of patients who achieve a best response of complete response (CR) at any moment since initiation of Epcoritamab first administration.

Secondary Endpoints
Efficacy of Epcoritamab monotherapy after 3 cycles
At the end of cycle 3 (each cycle is 28 days)
Efficacy of Epcoritamab monotherapy and combination therapy by CRR
Cycle 3, cycle 4, cycle 7, cycle 10, cycle 13 (for combination therapy) and EoT (28 days after last administration of investigational product) visits. Each cycle is 28 days.
Evaluation of MRD
Cycles 3, 4, 7, 10, 12, 13, 15 (each cycle is 28 days), EoT (28 days after last administration of Study drug) and cycles 18 and 24 (epcoritamab monotherapy) or cycles 21 and 27 (combination therapy) visits (each cycle is 28 days).
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
EPCO monotherapyEXPERIMENTALEpcoritamab in monotherapy will be administred until cycle 12.
Combination therapyEXPERIMENTAL3 cycles of Epcoritamab in monotherapy will be administred and then Epcoritamab will be administred with Tafasitamab and Lenalidomide from cycle 4 until cycle 15.
Interventions
NameTypeDescription
EpcoritamabDRUGPatients will receive 12 cycles of Epcoritamab monotherapy.
Epcoritamab, tafasitamab and lenalidomideDRUGPatients will receive 3 cycles of Epcoritamab monotherapy and then 12 cycles of Epcoritamab, Tafasitamab and Lenalidomide.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: 1. Written informed consent must be obtained before any study-specific assessment is performed. 2. Age \>18 years 3. Patients with Relapse/Refractory histologically confirmed LBCL, including, Diffuse Large B Cell Lymphoma (DLBCL); Primary Mediastinal Large B Cell Lymphoma (PMBCL...

Countries:Spain
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07126236primaryCompletionDate: changed
LOWMay 24, 2026NCT07126236studyFirstPostDate: changed