Asset profile

epcoritamab · Genmab (GMAB)

Indication: newly diagnosed diffuse large B-cell lymphoma (DLBCL) with IPI score of 2-5
Application: Phase 3 trial NCT04628494
Also known as: GEN3013, DuoBody-CD3xCD20, EPKINLY, TEPKINLY

Company

Genmab is a Copenhagen-based biotechnology company specializing in antibody therapeutics for the treatment of cancer. Genmab's proprietary antibody technologies are DuoBody, HexaBody, DuoHexaBody, and HexElect. Johnson & Johnson partnered with Genmab to create…

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On the calendar

18

Feb 2027

Feb 18, 2027

in 110 days

epcoritamab: Phase 2 trial NCT06723457 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.gov

30

Apr 2027

Apr 30, 2027

in 181 days

epcoritamab: Phase 2 trial NCT06510491 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.gov

10

Aug 2027

Aug 10, 2027

in 283 days

epcoritamab: Phase 2 trial NCT06112847 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.gov

24

Nov 2027

Nov 24, 2027

in 389 days

epcoritamab: Phase 2 trial NCT05852717 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.gov

~

Jan 2028

~ Jan 2028

epcoritamab: Phase 2 trial NCT06931652 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.govMonth only

16

Jul 2028

Jul 16, 2028

in 624 days

epcoritamab: Phase 2 trial NCT06575686 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.gov

~

Oct 2028

~ Oct 2028

epcoritamab: Phase 2 trial NCT07819214 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.govMonth only

31

Dec 2028

Dec 31, 2028

in 792 days

epcoritamab: Phase 2 trial NCT07783594 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.gov

~

Mar 2029

~ Mar 2029

epcoritamab: Phase 1/Phase 2 trial NCT05791409 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.govMonth only

08

Jun 2029

Jun 8, 2029

in 951 days

epcoritamab: Phase 2 trial NCT07218510 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.gov

31

Dec 2029

Dec 31, 2029

in 1157 days

epcoritamab: Phase 2 trial NCT07738887 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.gov

31

May 2030

May 31, 2030

in 1308 days

epcoritamab: Phase 2 trial NCT07097363 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.gov

07

Jan 2031

Jan 7, 2031

in 1529 days

epcoritamab: Phase 2 trial NCT06919939 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.gov

30

Sep 2031

Sep 30, 2031

in 1795 days

epcoritamab: Phase 1/Phase 2 trial NCT07283679 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.gov

27

Dec 2031

Dec 27, 2031

in 1883 days

epcoritamab: Phase 2 trial NCT07126236 expected to finish collecting primary-endpoint data (topline results usually follow)

Rescheduled — was Dec 1, 2031

Trial primary completionClinicalTrials.gov

~

Nov 2037

~ Nov 2037

epcoritamab: Phase 3 trial NCT06191744 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.govMonth only

Timeline

Newest first.

Oct 5, 2026

03:20 PM

epcoritamab · NCT05791409 registry update

Trial registry changeClinicalTrials.gov

Sep 29, 2026

03:20 PM

epcoritamab · NCT07126236 registry update

Trial registry changeClinicalTrials.gov

Jul 6, 2026

05:59 PM

Genmab: TEPKINLY + R2 approved by EC for 2L R/R follicular lymphoma

EMA opinionCompany press release Open record1 update

Jul 6, 2026

05:45 PM

AbbVie: EC approves TEPKINLY + R2 for R/R follicular lymphoma

EMA opinionCompany press release Open record2 updates

Jun 29, 2026

08:14 PM

Genmab: EPCORE DLBCL-4 Phase 3 met PFS endpoint for epcoritamab + lenalidomide

Topline resultsCompany press release Open record10 updates

Readiness checklist

Public facts only. We never publish an approval probability.

Updated Oct 5, 2026

Primary endpoint metFavourable

Genmab: EPCORE DLBCL-4 Phase 3 met PFS endpoint for epcoritamab + lenalidomide

Overall survival significant or trendingUnknown

US / Western patient shareMixed

107 of 586 sites in the United States

Advisory committee scheduledFavourable

No advisory committee announced

PDUFA date extendedUnknown

Manufacturing inspection recordUnknown

No public inspection record

Company language signals (label discussions)Unknown

Same-class precedentUnknown

Related companies

Each relationship is backed by the filing that stated it.

GMABGenmabPartner

ABBVAbbVieOwner

ABBVAbbViePartner

GMABGenmabOwner

Verify every date against the linked primary source. Informational only. Not investment advice. SimianX is not affiliated with the FDA or the SEC.

Registered trials

Registry ID	Phase	Status	Primary completion	Enrollment	Sites
NCT05791409	Phase 1/2	Recruiting	Mar 1, 2029	112	0 of 29 sites in the United States
NCT06510361	Phase 2	Recruiting	May 1, 2026	35	3 of 3 sites in the United States
NCT06510491	Phase 2	Recruiting	Apr 30, 2027	20	3 of 3 sites in the United States
NCT07738887	Phase 2	Not yet recruiting	Dec 31, 2029	44	0 of 29 sites in the United States
NCT06723457	Phase 2	Recruiting	Feb 18, 2027	34	1 of 1 sites in the United States
NCT05852717	Phase 2	Recruiting	Nov 24, 2027	35	4 of 4 sites in the United States
NCT07819214	Phase 2	Not yet recruiting	Oct 1, 2028	24	1 of 1 sites in the United States
NCT06191744	Phase 3	Active, not recruiting	Nov 1, 2037	1095	58 of 266 sites in the United States
NCT07783594	Phase 2	Not yet recruiting	Dec 31, 2028	40	1 of 1 sites in the United States
NCT06112847	Phase 2	Active, not recruiting	Aug 10, 2027	29	2 of 2 sites in the United States
NCT07218510	Phase 2	Recruiting	Jun 8, 2029	33	7 of 7 sites in the United States
NCT06931652	Phase 2	Recruiting	Jan 1, 2028	60	0 of 13 sites in the United States
NCT04628494	Phase 3	Active, not recruiting	Oct 13, 2025	483	15 of 186 sites in the United States
NCT07283679	Phase 1/2	Recruiting	Sep 30, 2031	30	1 of 1 sites in the United States
NCT04358458	Phase 1/2	Terminated	Nov 21, 2022	46	7 of 17 sites in the United States
NCT07126236	Phase 2	Recruiting	Dec 27, 2031	80	0 of 19 sites in the United States
NCT06575686	Phase 2	Suspended	Jul 16, 2028	33	2 of 2 sites in the United States
NCT07097363	Phase 2	Recruiting	May 31, 2030	18	1 of 1 sites in the United States
NCT06919939	Phase 2	Recruiting	Jan 7, 2031	26	1 of 1 sites in the United States

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epcoritamab · Genmab (GMAB) — FDA Timeline & Readiness Checklist | SimianX AI