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Epcoritamab

Phase 3

Diffuse Large B-Cell Lymphoma | Monoclonal antibody | Oncology |Genmab A/S|Last Updated: Jun 2, 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
RandomizedCONTROLLEDDMCBiomarker
Total Trials7
Total Enrollment2,673
FDA Designations
No designations recorded
Clinical Trials (7)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05578976A Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)PHASE3 ACTIVE NOT_RECRUITING 900Feb 1, 2023Dec 1, 2029Jan 22, 2025 -
NCT07226752A Sub-study Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL) in ChinaPHASE3 ACTIVE NOT_RECRUITING 72Oct 1, 2022Jun 1, 2028Mar 2, 2026 -
NCT04628494A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL)PHASE3 ACTIVE NOT_RECRUITING 484Jan 1, 2021Apr 1, 2028Mar 2, 2026 -
NCT06508658A Study of Subcutaneously Injected Epcoritamab Plus Oral Lenalidomide Tablets Compared to Intravenously (IV) Infused Rituximab Plus IV Infused Gemcitabine and IV Infused Oxaliplatin in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell LymphomaPHASE3 ACTIVE NOT_RECRUITING 379Aug 13, 2024Mar 1, 2028Apr 8, 2026176 United States, Argentina +26
NCT05660967Subcutaneous Epcoritamab With or Without Lenalidomide as First Line Therapy for Diffuse Large B-Cell LymphomaPHASE2 ACTIVE NOT_RECRUITING 111Mar 1, 2023Jun 1, 2026Mar 2, 2026 -
NCT05451810A Study to Evaluate Adverse Events of Subcutaneous (SC) Epcoritamab Administered in the Outpatient Setting in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Classic Follicular LymphomaPHASE2 ACTIVE NOT_RECRUITING 184Aug 17, 2022Mar 1, 2027Jan 24, 202572 United States, Puerto Rico
NCT04663347Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)PHASE1 ACTIVE NOT_RECRUITING 543Nov 3, 2020Sep 30, 2027Jun 2, 202657 United States, Australia +11
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Study Endpoints
Primary Endpoints
Arm A vs Arm B: Progression-Free Survival (PFS)
Up to 4 Years

PFS is defined as the duration from the date of randomization to the date of disease progression determined per Lugano 2014 criteria as assessed by an independent review committee (IRC), or death, whichever occurs first.

Percentage of Participants Experiencing Grade 3 or Higher Cytokine Release Syndrome (CRS) Events
Up to 3 Months

Cytokine Release Syndrome events will be graded using American Society for Transplantation and Cellular Therapy (ASTCT), with a higher grade indicating higher severity.

Percentage of Participants Experiencing Grade 3 or Higher Immune Cell-Associated Neurotoxicity Syndrome (ICANS) Events
Up to 3 Months

ICANS events will be graded using ASTCT, with a higher grade indicating higher severity.

Percentage of Participants Experiencing Grade 3 or Higher Neurotoxicity (Ntox) Events
Up to 3 Months

Ntox is defined as the percentage of participants who developed at least 1 Grade 3 or higher Ntox since the initiation of epcoritamab treatment.

Part 1: Number of Participants With Dose limiting Toxicities (DLTs)
During the first cycle (Cycle length= 28 days) in each cohort

DLT events are defined as clinically significant adverse events (AEs) or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications as assessed per Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria version 5.0.

Part 1 and Part 2 (Arms 1-5, 7 and 10): Number of Participants With Adverse Events (AEs)
From first dose of drug until either 60 days after last dose, date participant withdraws consent, date participant starts a new systemic anticancer therapy, or date participant dies, whichever occurs first (up to approximately 3 years)

An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign. (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

Part 2 (Except Arm 7): Overall Response Rate (ORR)
Up to 3 years

ORR is defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on Lugano criteria.

Secondary Endpoints
Arm A vs Arm B: Percentage of Participants Who Achieve Complete response (CR)
Up to 4 Years
Arm A vs Arm B: Overall Survival (OS)
Up to 4 Years
Arm A vs Arm B: Percentage of Participants Who Achieve Minimal Residual Disease (MRD) Negativity Rate
Up to 4 Years
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Study Design & Arms
Treatment Arms
ArmTypeDescription
Arm A: Epcoritamab Plus Lenalidomide (E-Len)EXPERIMENTALParticipants will receive E-Len for up to 12 cycles (each cycle is 28 days).
Arm B: Rituximab Plus Gemcitabine and Oxaliplatin (R-GemOx)EXPERIMENTALParticipants will receive R-GemOx for up to 4 cycles (each cycle is 28 days)
Arm C: EpcoritamabEXPERIMENTALParticipants will receive epcoritamab for up to 12 cycles (each cycle is 28 days).
Main Cohort: Epcoritamab Diffuse Large B-Cell Lymphoma (DLBCL)EXPERIMENTALParticipants with relapsed or refractory (R/R) DLBCL will receive subcutaneous (SC) epcoritamab in 28 day cycles.
Main Cohort: Epcoritamab Classic Follicular Lymphoma (cFL)EXPERIMENTALParticipants with R/R cFL will receive SC epcoritamab in 28 day cycles.
Diversity Enriched Cohort: Epcoritamab DLBCLEXPERIMENTALParticipants with R/R DLBCL will receive SC epcoritamab in 28 day cycles.
Diversity Enriched Cohort: Epcoritamab cFLEXPERIMENTALParticipants with R/R cFL will receive SC epcoritamab in 28 day cycles.
Arm 1 - Epcoritamab + R-CHOPEXPERIMENTALIn participants with previously untreated DLBCL.
Arm 2 - Epcoritamab + R2EXPERIMENTALIn participants with R/R FL.
Arm 3 - Epcoritamab + BREXPERIMENTALIn participants with previously untreated FL.
Arm 4 - Epcoritamab + R-DHAX/CEXPERIMENTALIn participants with R/R DLBCL eligible for ASCT.
Arm 5 - Epcoritamab + GemOxEXPERIMENTALIn participants with R/R DLBCL ineligible ASCT.
Arm 6 - Epcoritamab + R2EXPERIMENTALIn participants with previously untreated FL.
Arm 7 - Epcoritamab maintenanceEXPERIMENTALIn participants with FL who achieved a CR or PR after receiving SOC treatment in 1L or 2L.
Arm 8 - Epcoritamab + R mini-CHOPEXPERIMENTALIn participants with previously untreated DLBCL who are ineligible to receive full-dose anthracycline.
Arm 9 - Epcoritamab + LenalidomideEXPERIMENTALIn participants with R/R FL who progressed within 24 months of initiation of first-line anti-CD20-containing immunochemotherapy.
Arm 10 - Epcoritamab + R-ICEEXPERIMENTALIn participants with R/R DLBCL eligible for ASCT.
Interventions
NameTypeDescription
EpcoritamabDRUGSubcutaneous Injection (SC)
CyclophosphamideDRUGIntravenous (IV) Injection
RituximabDRUGIV Infusion
VincristineDRUGIV Infusion
DoxorubicinDRUGIV Infusion
PrednisoneDRUGOral; Tablet
Investigator's Choice ChemotherapyDRUGFollowing mandatory pre-medication, participants will be administered intravenously either BR or R-GemOx.
LenalidomideDRUGOral Capsule
OxaliplatinDRUGIV Infusion
GemcitabineDRUGIV Infusion
rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisoneDRUG6 cycles (21-day cycles)
rituximab and lenalidomideDRUGrituximab 6 cycles and lenalidomide 12 cycles (28-day cycles)
rituximab and bendamustineDRUG6 cycles (28-day cycles)
rituximab, cytarabine, dexamethasone, and oxaliplatin/carboplatinDRUG3 cycles (21-day cycles)
gemcitabine and oxaliplatinDRUG4 cycles (28-day cycles)
rituximab, cyclophosphamide, reduced dose of doxorubicin, vincristine, and prednisoneDRUG6 cycles (21-day cycles)
rituximab, ifosfamide, carboplatin, and etoposide phosphateDRUG3 cycles (21-day cycles)
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Eligibility Criteria
Age Range18 Years — N/A
SexALL

Inclusion Criteria: * Eastern Cooperative Oncology Group Performance status score of 0 to 2. * Histologically confirmed CD20+ Diffuse Large B-Cell Lymphoma (DLBCL) and documented in the most recent and representative pathology report, inclusive of the following according to the World Health Organiz...

Countries:United StatesArgentinaAustraliaBelgiumBrazilBulgariaCanadaChileChinaCroatiaCzechiaFranceGreeceHungaryJapanMexicoNetherlandsNew ZealandPolandPortugalRomaniaSerbiaSingaporeSouth AfricaSouth KoreaTaiwanTurkey (Türkiye)United KingdomPuerto RicoDenmarkFinlandItalyNorwaySpainSweden
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Recent Changes (Last 90 Days)
LOWJun 2, 2026NCT04663347lastUpdatePostDate: changed
LOWJun 2, 2026NCT04663347lastUpdatePostDate: changed
LOWJun 2, 2026NCT04663347lastUpdatePostDate: changed
LOWMay 26, 2026NCT04663347primaryCompletionDate: changed
LOWMay 26, 2026NCT05451810primaryCompletionDate: changed
MEDIUMMay 26, 2026NCT06508658Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 24, 2026NCT06508658studyFirstPostDate: changed
LOWMay 24, 2026NCT07226752studyFirstPostDate: changed
LOWMay 24, 2026NCT04628494studyFirstPostDate: changed
LOWMay 24, 2026NCT05660967studyFirstPostDate: changed
LOWMay 24, 2026NCT05578976studyFirstPostDate: changed
LOWMay 24, 2026NCT04663347studyFirstPostDate: changed
LOWMay 24, 2026NCT05451810studyFirstPostDate: changed