Epkinly

(Epcoritamab)

Phase 3Monoclonal antibody

Epcoritamab is used to treat a type of blood cancer called diffuse large B-cell lymphoma (DLBCL) in adult patients who have already tried other treatments. It works by helping the immune system recognize and attack cancer cells.[1] Epkinly is currently being investigated across 22 indications[3], with its most advanced program in Phase 3.[1]

Epkinly is one of 319 bispecific antibody programs targeting Non-Hodgkins Lymphoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

318

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Non-Hodgkins LymphomaActive, not recruiting

B-Cell NeoplasmActive, not recruiting

Central Nervous System LymphomaActive, not recruiting

LymphomaActive, not recruiting

B-Cell Non-Hodgkins LymphomaUnknown

ImmunodeficiencyActive, not recruiting

Non-Small Cell Lung CancerRecruiting

Mantle Cell LymphomaActive, not recruiting

Diffuse Large B-Cell LymphomaTerminated

Chronic Lymphocytic LeukemiaActive, not recruiting

Non-Hodgkins LymphomaPhase 2

Active, not recruiting

B-Cell NeoplasmPhase 1

Active, not recruiting

Central Nervous System LymphomaPhase 1

Active, not recruiting

LymphomaPhase 2

Active, not recruiting

B-Cell Non-Hodgkins LymphomaPreclinical

Unknown

ImmunodeficiencyPhase 2

Active, not recruiting

Non-Small Cell Lung CancerPhase 2

Recruiting

Mantle Cell LymphomaPhase 1

Active, not recruiting

Diffuse Large B-Cell LymphomaPhase 2

Terminated

Chronic Lymphocytic LeukemiaPhase 2

Active, not recruiting

Showing 10 of 22 indications

Competition

Competitive Landscape

1774 competitors in Lymphoma

#DrugCompanyPhaseTrials

Epkinly

Genmab

Phase 3

11 2

Velban

EEastern Cooperative Oncology Group

Preclinical

15 3

Oncaspar

SServier

Preclinical

15 4

Norvir

AbbVie

Preclinical

1 5

Wellcovorin

GGlaxo Dba Glaxosmithkline

Preclinical

4 6

Emend

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

1 7

Kenalog

BBausch Health Americas, Inc.

Preclinical

1 8

Nuvigil

NNuvo Research GmbH

Preclinical

1 9

PEG-Intron

Merck & Co.

Preclinical

1 10

Systemic Therapy

Bristol-Myers Squibb

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1Recruiting

Lymphoproliferative Disorders

NCT06672705

Q1 2027

Phase 2Active, not recruiting

Diffuse Large B-Cell Lymphoma

NCT05451810

Q3 2027

Phase 1Active, not recruiting

Leukemia, Chronic Lymphocytic

NCT06676033

Phase 2Recruiting

DLBCL

NCT07451652

PreclinicalActive, not recruiting

Diffuse Large B-Cell Lymphoma

NCT04542824

PreclinicalActive, not recruiting

Diffuse Large B-Cell Lymphoma

NCT04663347

Clinical

Trials by Indication[1]

Diffuse Large B-Cell Lymphoma11 trials

A Sub-study Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL) in China

Active, not recruiting· Genmab logo

Genmab·Phase 3·NCT07226752·72 enrolled

A 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)

Active, not recruiting· Genmab logo

Genmab·Phase 3·NCT05578976·900 enrolled

A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL)

Active, not recruiting· Genmab logo

Genmab·Phase 3·NCT04628494·484 enrolled

Show 8 more trials

Study of Epcoritamab in R/R Primary Diffuse Large B-cell Lymphoma of the CNS Treated With Lenalidomide and Rituximab

Recruiting·TThe Lymphoma Academic Research Organisation·Phase 2·NCT06931652·60 enrolled

A 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 Lymphoma

Recruiting· Genmab logo

Genmab·Phase 3·NCT06508658·360 enrolled

Phase 2 Trial of Epcoritamab in Combination With Rituximab-mini CVP for Older Unfit/Frail Patients or Anthracycline-Ineligible Adult Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT06045247·40 enrolled

Epcoritamab, Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) as Salvage Therapy Before Autologous Stem Cell Transplant for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Not yet recruiting·—·Phase 2·NCT07365306·43 enrolled

A 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 Lymphoma

Active, not recruiting· Genmab logo

Genmab·Phase 2·NCT05451810·184 enrolled

A Phase 1b/2, Open-Label Trial to Assess the Safety and Preliminary Efficacy of Epcoritamab (GEN3013; DuoBody®-CD3xCD20) in Combination With Other Agents in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)

Active, not recruiting· Genmab logo

Genmab·Preclinical·NCT04663347·543 enrolled

Safety and Preliminary Efficacy of Epcoritamab (GEN3013; DuoBody®-CD3×CD20) in Japanese Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma - A Phase 1/2, Open-Label, Dose-Escalation Trial With Expansion Cohorts

Active, not recruiting· Genmab logo

Genmab·Preclinical·NCT04542824·78 enrolled

Efficacy and Safety of Epcoritamab Monotherapy and in Combination With Lenalidomide as First-line Therapy for Anthracycline-ineligible Diffuse Large B-Cell Lymphoma Patients, an Open-label, Randomized, Multicenter, Global Phase 2 Trial

Terminated· Genmab logo

Genmab·Phase 2·NCT05660967·111 enrolled

Lymphoma11 trials

MRD-Directed Consolidation With Epcor-only or Epcor-R2 Post Anti-CD19 CAR TCell Therapy for Large B-Cell Lymphoma

Recruiting·PPeter MacCallum Cancer Centre, Australia·Phase 2·NCT06414148·40 enrolled

Epcoritamab Compared to Observation for Treating B-cell Lymphoma Patients Not in Complete Remission After CD19-directed CAR-T Therapy

Recruiting·—·Phase 2·NCT06238648·120 enrolled

Epcoritamab-CAR T Cells for Large B-cell Lymphomas

Recruiting·—·Phase 2·NCT06458439·31 enrolled

Show 8 more trials

Epcoritamab in Combination With Loncastuximab Tesirine in Relapsed/Refractory Large B-cell Lymphoma

Recruiting·UUniversity of Miami·Phase 2·NCT06919939·26 enrolled

First-in-Human (FIH) Trial of GEN3009 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas

Terminated· Genmab logo

Genmab·Phase 1/2·NCT04358458·46 enrolled

Epcoritamab Plus Ibrutinib for the Treatment of Relapsed or Refractory Aggressive B-Cell Non-Hodgkin Lymphoma

Recruiting·YYazeed Sawalha·Phase 1/2·NCT06536049·38 enrolled

A Study of Epcoritamab With Lenalidomide and Tafasitamab in People With Diffuse Large B Cell Lymphoma

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT07030699·27 enrolled

A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab As Monotherapy or Combined With Standard of Care Therapies in Adult Participants in China With B-Cell Non-Hodgkin Lymphoma

Active, not recruiting· Genmab logo

Genmab·Phase 1/2·NCT05201248·49 enrolled

Epcoritamab With Dose Adjusted Etoposide, Cyclophosphamide, Vincristine, Doxorubicin, Prednisone and Rituximab (EPOCH-R) for the Treatment of Aggressive B-Cell Non-Hodgkin Lymphoma

Recruiting·UUniversity of Washington·Phase 2·NCT07097363·18 enrolled

Response-adaptive to Epcoritamab In First Relapse: Study to Evaluate the Efficacy of Eptoritamab in Patients With Relapse/Refractory Large B Cell Lymphoma

Recruiting·GGrupo Español de Linfomas y Transplante Autólogo de Médula Ósea·Phase 2·NCT07126236·80 enrolled

Epcoritamab in Patients With Newly Diagnosed Marginal Zone Lymphoma (MZL)

Recruiting·—·Phase 2·NCT06796998·25 enrolled

Follicular Lymphoma5 trials

Lenalidomide and Epcoritamab for the Treatment of Previously Untreated Follicular Lymphoma

Suspended·—·Phase 2·NCT06112847·29 enrolled

Epcoritamab and Tazemetostat for the Treatment of Relapsed or Refractory Grade I-IIIa Follicular Lymphoma

Suspended·—·Phase 2·NCT06575686·33 enrolled

Epcoritamab and Rituximab for First-line Follicular Lymphoma

Recruiting·—·Phase 2·NCT05783609·100 enrolled

Show 2 more trials

Epcoritamab in Patients With Follicular Lymphoma Not Accomplishing a CR With Upfront Chemoimmunotherapy

Recruiting·—·Phase 2·NCT06510361·35 enrolled

Relapsed Follicular Lymphoma Randomised Trial Against Standard ChemoTherapy

Recruiting·UUniversity of Birmingham·Phase 2·NCT05848765·284 enrolled

DLBCL3 trials

Low Dose Epcoritamab Plus GemOx in R/R DLBCL

Recruiting·HHospital Universitario Dr. Jose E. Gonzalez·Phase 2·NCT07451652·10 enrolled

Outpatient Epcoritamab as 2L in NTE R/R DLBCL

Recruiting·MMassachusetts General Hospital·Phase 2·NCT06811272·30 enrolled

A Phase 1/2, Open-label Safety Trial of GEN3013 in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma

Active, not recruiting· Genmab logo

Genmab·Preclinical·NCT03625037·666 enrolled

ESS2 trials

Expanded Access Program for Epcoritamab

Approved for marketing· Genmab logo

Genmab··NCT05733650

Expanded Access to Epcoritamab

No longer available· AbbVie logo

AbbVie··NCT05692050

18 more indications

Follicular Lymphoma (FL)2 trials

A Phase 3, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With Rituximab and Lenalidomide (R2) Compared to R2 in Subjects With Relapsed or Refractory Follicular Lymphoma (EPCORE FL-1)

Active, not recruiting· Genmab logo

Genmab·Phase 3·NCT05409066·549 enrolled

A Phase 3, Multicenter, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of Epcoritamab + Rituximab and Lenalidomide (R2) Compared to Chemoimmunotherapy in Previously Untreated Follicular Lymphoma (EPCORE™FL-2)

Recruiting· Genmab logo

Genmab·Phase 3·NCT06191744·1,095 enrolled

Non-Hodgkin Lymphoma2 trials

Phase 1b/2, Open-Label Study to Evaluate Safety and Tolerability of Epcoritamab in Combination With Anti-Neoplastic Agents in Subjects With Non-Hodgkin Lymphoma

Active, not recruiting· Genmab logo

Genmab·Phase 2·NCT05283720·264 enrolled

Pilot Safety-feasibility Study of Cytokine Release Syndrome Prophylaxis and Treatment With Siltuximab Prior to Epcoritamab

Recruiting·TTaylor Brooks·Phase 1·NCT06447376·20 enrolled

Central Nervous System Lymphoma1 trial

A Study of Epcoritamab and Ibrutinib in People With Central Nervous System Lymphoma (CNSL)

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT07082868·26 enrolled

B-cell neoplasm1 trial

Study of the Adverse Events and Change in Disease State of Pediatric Participants (and Young Adults Between the Ages of 18-25) With Relapsed/Refractory Aggressive Mature B-cell Neoplasms Receiving Subcutaneous (SC) Injections of Epcoritamab

Active, not recruiting· Genmab logo

Genmab·Phase 1·NCT05206357·17 enrolled

Lymphoproliferative Disorders1 trial

Epcoritamab for the Treatment of Relapsed or Refractory Post Transplant Lymphoproliferative Disorders

Recruiting·TTimothy Voorhees·Phase 1·NCT06672705·26 enrolled

Relapse1 trial

Epcoritamab (Epcor)-Containing Combination Salvage Therapy Followed by ASCT & Epcor Consolidation in Patients With Relapsed LBCL

Recruiting·AAustralasian Leukaemia and Lymphoma Group·Phase 2·NCT06287398·39 enrolled

Consolidation Therapy1 trial

Study of Epcoritamab as a Consolidation Therapy in CLL/SLL

Recruiting·ZZulfa Omer·Phase 2·NCT07108998·22 enrolled

Chronic Lymphocytic Leukemia1 trial

Venetoclax and Obinutuzumab Followed by Epcoritamab for the Treatment of Untreated Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, LonGEVity Trial

Recruiting·—·Phase 2·NCT07218510·33 enrolled

Relapsed or Refractory1 trial

Venetoclax Treatment (26 Cycles) With 6 Cycles or 12 Cycles of Epcoritamab in Patients With Relapsed or Refractory CLL or SLL

Recruiting·SStichting Hemato-Oncologie voor Volwassenen Nederland·Phase 1/2·NCT05791409·112 enrolled

TED1 trial

Epcoritamab in Previously Treated WM

Recruiting·GGottfried von Keudell, MD PhD·Phase 2·NCT06510491·20 enrolled

PCO1 trial

Epco, Zanu, Ritux for R/R FL or MZL

Recruiting·—·Phase 2·NCT06563596·45 enrolled

Large Cell Lymphoma, Diffuse1 trial

A Phase II Trial Evaluating Safety and Efficacy of Epcoritamab With Gemcitabine, Dexamethasone, and Cisplatin (GDP) Salvage Chemotherapy in Relapsed Refractory Large B-cell Lymphoma

Recruiting·DDipenkumar Modi·Phase 2·NCT05852717·35 enrolled

Recurrent B-Cell Non-Hodgkin Lymphoma1 trial

A Phase II Study of Combination Epcoritamab-Lenalidomide in Patients With Refractory/Relapsed Immunodeficiency-Related Large B-Cell Lymphoma

Recruiting·NNorthwestern University·Phase 2·NCT06723457·34 enrolled

Leukemia, Chronic Lymphocytic1 trial

Correlative Study of Epcoritamab in Chronic Lymphocytic Leukemia and Richter Syndrome

Active, not recruiting·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 1·NCT06676033·5 enrolled

Relapsed/Refractory Chronic Lymphocytic Leukemia1 trial

A Phase 1b/2, Open-Label, Safety and Efficacy Study of Epcoritamab (GEN3013; DuoBody®-CD3xCD20) in Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome

Active, not recruiting· Genmab logo

Genmab·Preclinical·NCT04623541·194 enrolled

Recurrent Diffuse Large B-Cell Lymphoma1 trial

A Phase 2 Study of Epcoritamab (Epco) Plus Physician's Choice of Platinum-Containing Chemotherapy Pre-Autologous Hematopoietic Cell Transplantation (AutoHCT) Followed by Post-AutoHCT Epco Consolidation/ Maintenance in Relapsed/ Refractory Large B-Cell Lymphoma (R/R LBCL)

Recruiting·JJoseph Tuscano·Phase 2·NCT06905509·25 enrolled

Burkitt Lymphoma1 trial

Epcoritamab in Combination With Dose Adjusted R-EPOCH for High Risk Burkitt Lymphoma (BL) (BEDROCK Study)

Not yet recruiting·AAIDS Malignancy Consortium·Phase 2·NCT07662928·43 enrolled

Relapsed/Refractory Non-Hodgkin Lymphoma1 trial

A Phase 1/2, Multi-Center, Open-Label, Dose-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BMS-986458, Alone and in Combination With Anti-lymphoma Agents in Participants With Relapsed/Refractory Non-Hodgkin Lymphomas (R/R NHL)

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Preclinical·NCT06090539·460 enrolled

Regulatory

FDA Approval Timeline[4]

May 19, 2023

EPKINLY

BLA BLA761324

Sources

References

[1]
ClinicalTrials.gov — 52 trial records for Epcoritamab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Epcoritamab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Epcoritamab. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA761324). U.S. Food & Drug Administration.
[5]
PubMed — 1 publication indexed for Epcoritamab. U.S. National Library of Medicine.
[6]
SEC EDGAR — Genmab company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Cd3xcd20 Bispecific[2]
Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: Genmab

Key Publications[5]

Epcoritamab in Relapsed/Refractory DLBCL: EPCORE NHL-1

N Engl J MedApr 14, 2023DOI: 10.1056/NEJMoa2302968

Epkinly

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q3 2027

Trials by Indication[1]

Diffuse Large B-Cell Lymphoma11 trials

Lymphoma11 trials

Follicular Lymphoma5 trials

DLBCL3 trials

ESS2 trials

Follicular Lymphoma (FL)2 trials

Non-Hodgkin Lymphoma2 trials

Central Nervous System Lymphoma1 trial

B-cell neoplasm1 trial

Lymphoproliferative Disorders1 trial

Relapse1 trial

Consolidation Therapy1 trial

Chronic Lymphocytic Leukemia1 trial

Relapsed or Refractory1 trial

TED1 trial

PCO1 trial

Large Cell Lymphoma, Diffuse1 trial

Recurrent B-Cell Non-Hodgkin Lymphoma1 trial

Leukemia, Chronic Lymphocytic1 trial

Relapsed/Refractory Chronic Lymphocytic Leukemia1 trial

Recurrent Diffuse Large B-Cell Lymphoma1 trial

Burkitt Lymphoma1 trial

Relapsed/Refractory Non-Hodgkin Lymphoma1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Key Publications[5]

Related News