Innovating

Antibodies,

Improving Lives

Investor Presentation November 2020

Forward Looking Statement

This presentation contains forward looking statements. The words "believe", "expect", "anticipate", "intend" and "plan" and similar expressions identify forward looking statements. All statements other than statements of historical facts included in this presentation, including, without limitation, those regarding our financial position, business strategy, plans and objectives of management for future operations (including development plans and objectives relating to our products), are forward looking statements. Such forward looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward looking statements. Such forward looking statements are based on numerous assumptions regarding our present and future business strategies and the environment in which we will operate in the future. The important factors that could cause our actual results, performance or achievements to differ materially from those in the forward looking statements include, among others, risks associated with product discovery and development, uncertainties related to the outcome of clinical trials, slower than expected rates of patient recruitment, unforeseen safety issues resulting from the administration of our products in patients, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products obsolete, and other factors. Further, certain forward looking statements are based upon assumptions of future events which may not prove to be accurate. The forward looking statements in this document speak only as at the date of this presentation. Genmab does not undertake any obligation to update or revise forward looking statements in this presentation nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.

2

Our Core Purpose, Strategy & Vision Guide Our Work

Core Purpose

Our Strategy

Vision

To improve the lives of patients

Turn science into medicine

By 2025, our own product has

by creating & developing innovative

transformed cancer treatment and

antibody products

Build a profitable & successful biotech

we have a pipeline of knock-your-

socks off antibodies

Focus on Core Competence

3

The Genmab Difference

Innovation Powerhouse Transforming Cancer Treatment & Creating Value

Strong pipeline

of 1st-in-class /

best-in-class

products

Proprietary

technologies

Deep insight into

allow us

antibody biology

to build a

& disease targets

world-class

pipeline

Match in-house

expertise with

strategic

partnerships

4

Track Record & Growth

Over 20 Years

of Achievement

37 Cumulative INDs since 1999

23 Genmab created product candidates in Ongoing Clinical Trials

Multiple Genmab-created Products

Approved

7 Years of Profitability

  • Expanding Top Line
    Dual-listed in US & DK with 2019 US IPO

5

Solid Foundation Built

on a Differentiated Pipeline

Potential 1st-in-Class/Best-in-Class

Our Own Clinical Pipeline

Tisotumab Vedotin5

DuoBody-CD40x4-1BB7

Enapotamab Vedotin

DuoBody-PD-L1x4-1BB7

HexaBody®-DR5/DR5

DuoHexaBody®-CD376

Epcoritamab (DuoBody®-CD3xCD20)6

DuoBody-CD3x5T46

R&D Engine

Technologies & Pre-Clinical(innovaTV

• DuoBody technology 206) study

• HexaBody technology in

• HexElect® technology Japanese

• DuoHexaBody® technology population

• Rich Pre-Clinical Pipeline incl. HexaBody-CD388

Solid Financial Base

Approved Partnered Products

•DARZALEX® (daratumumab) / DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj)1

•Kesimpta® (ofatumumab)2 •TEPEZZA® (teprotumumab)3 •Arzerra® (ofatumumab)4

Programs Built on Genmab's Innovation

Partner-owned Programs in the Clinic

  • 15 product candidates in clinical development w/ partners
  • Incl. 7 DuoBody products with Janssen, 1 with Novo Nordisk

6

1In dev. by Janssen; 2 in dev. by Novartis; 3In dev. by Horizon; 4Commercialized by Novartis, no longer in active development. 550:50 w/ Seattle Genetics; 650:50 w/ AbbVie; 750:50 w/ BioNTech, GEN1046 & GEN1042 respectively; 8Genmab is developing HexaBody-CD38 in an exclusive worldwide license and option agreement with Janssen Biotech, Inc

DARZALEX® (daratumumab) & DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj): Redefining Treatment of Multiple Myeloma

First-in-class CD38 antibody in development to treat cancer

Collaboration with Janssen: Genmab entitled to tiered royalty of 12-20% of net sales

Approved in certain territories for various multiple myeloma (MM) indications1

DARZALEX FASPRO first and only SubQ CD38 mAb approved in U.S. for treatment of MM

$

2019 WW net sales by J&J: $2,998M

See local country prescribing information for approved indications

7

DARZALEX Approvals: US and EU

On Track for Approval Across All Lines of MM Treatment

US Approvals

US Submissions:

November

November

June 2017,

May 2018,

September 2019,

May 2020,

August 2020

June 2019,

DARZALEX FASPRO

2016, RRMM

RRMM

FLMM NTE

February 2019,

2015,

(CASTOR;

FLMM NTE

FLMM TE

(COLUMBA;

RRMM

Monotherapy

(EQUULEUS),

(ALCYONE),

Split dosing

(CASSIOPEIA),

(CANDOR),

POLLUX),

(MAIA), D-Rd

PLEIADES)

(SIRIUS)

D-Vd,D-Rd

D-Pd

D-VMP

D-VTd

D-Kd

Subcutaneous

EU Approvals

EU Submissions:

April 2016,

February 2017,

June 2018, FLMM

December

November

January 2020,

June 2020,

Monotherapy

RRMM (CASTOR;

NTE (ALCYONE),

2018,

2019, FLMM

FLMM TE

Subcutaneous

(SIRIUS)

POLLUX), D-Vd,

D-VMP

Split dosing

NTE (MAIA),

(CASSIOPEIA),

(COLUMBA;

D-Rd

D-Rd

D-VTd

PLEIADES)

8

Daratumumab

Proving to be the Critical Driver Across Different Combinations & Treatment Lines

sCR Odds Ratio1 or CR+2

MRD-neg rate

PFS risk reduction

Frontline

Relapsed/Refractory

Transplant Eligible

Transplant Ineligible

Ph 3

Ph 2

Ph 3

Ph 3

Ph 3

Ph 3

Ph 3

CASSIOPEIA1,3

GRIFFIN1,4

ALCYONE2,4

MAIA2,4

POLLUX2,4

CASTOR2,4

CANDOR2,4

(D-VTd vs. VTd)

(D-VRd vs VRd)

(D-VMP vs. VMP)

(D-Rd vs. Rd)

(D-Rd vs. Rd)

(D-Vd vs Vd)

(D-Kd vs Kd)

1.60

1.57

~2x

~2x

>2x

3x

~3x

1.5x

2.5x

4x

>3x

~5x

>7x

~10x

53%

NA

58%

44%

56%

69%

37%

(HR, 0.47)

(HR, 0.42)

(HR, 0.56)

(HR, 0.44)

(HR, 0.31)

(HR, 0.63)

Ongoing Phase 3: CEPHEUS (D-VRd, NDMM NTE), PERSEUS (D-VRd, NDMM TE)

3Data as per ASCO 2019;

4Data as per ASH 2019

9

Improved Survival for Patients with Multiple Myeloma

Overall Survival Analysis from ALCYONE Trial

Kaplan-Meier estimates of overall survival in intention-to-treat population. Mateos, MV et al, 'Overall survival with daratumumab, bortezomib, melphalan, and prednisone in newly

10

diagnosed multiple myeloma (ALCYONE): a randomized, open-label, phase 3 trial,' The Lancet, published online December 9, 2019

Kesimpta® (ofatumumab)

Approved in Relapsing Multiple Sclerosis

Human CD20 Antibody - well validated target

Injection for SubQ use approved for RMS in the US

First B-cell therapy that can be self-administered by patients at home using Sensoready® autoinjector pen

Developed by Novartis: Regulatory submission also

made in EU

$

Genmab 10% royalty payment of net sales

Second Genmab-created product with blockbuster potential

11

Tisotumab Vedotin

Genmab's Most Advanced Asset with Potential in Solid Tumors

Fully human antibody-drug conjugate (ADC) targeting Tissue

Factor (TF) in development to treat solid tumors

License and collaboration agreement with Seattle

Genetics 50:50

Very favorable topline results, Phase 2 recurrent or metastatic cervical cancer

Ongoing trials in cervical, ovarian cancer, other solid tumors

Expanding development, additional studies planned

12

Tisotumab Vedotin in Cervical Cancer

Designed to Address a High Unmet Medical Need

Recurrent or metastatic cervical cancer

  • Poor prognosis advanced / recurrent cervical cancer
    • RR standard therapies generally <15%
    • Median OS 6-8 months
  • Data ORR & survival after progression on 1L bevacizumab + doublet chemotherapy are limited

Conclusions*

(previously treated recurrent or metastatic cervical cancer)

  • Compelling and durable antitumor activity with manageable and tolerable safety profile
  • ORR 24%; CR: 7%
  • Median DOR 8.3 mo
  • Median PFS (4.2 mo) and OS (12.1 mo) encouraging

Clinically meaningful and durable responses observed*

N=101

Confirmed ORR (95% CI),a %

24 (15.9−33.3)

CR, n (%)

7

(7)

PR, n (%)

17

(17)

SD, n (%)

49

(49)

PD, n (%)

24

(24)

Not evaluable, n (%)

4

(4)

Response

1.00

DOR

0.60

in

0.80

Remaining

0.40

Median DOR

(95% CI)

0.20

8.3 months

(4.2−NR)

0

0

2

4

6

8

10

12

Time (months)

No. at risk 24

22

16

11

8

3

0

*Data from innovaTV 204 study, Coleman R, et al. Tisotumab Vedotin in Cpreviously Treated Recurrent or Metastatic Cervical Cancer: Results from the Phase 2 innovaTV 204 / GOG-3023/ENGOT-cx6 Study, ESMO September 21, 2020. Data cutoff: February 06, 2020. Median13

duration of follow-up: 10.0 months. CI, confidence interval; CR, complete response; DOR, duration of response; IRC, independent review committee; NR, not reached; ORR, objective response rate; PD, disease progression; PR, partial response; SD, stable disease.

Enapotamab Vedotin

Potential in Solid Tumors

Fully human ADC, targets tumor-associated AXL

AXL over-expressed on many resistant tumors

Ph 1/2 study ongoing solid tumors

Expansion cohorts recruiting

ADC technology license from Seattle Genetics

Fully owned by Genmab

14

Epcoritamab (DuoBody-CD3xCD20)

Potential for Improved Efficacy & Safety in B Cell Malignancies

Potential best-in-class therapeutic

T cell-mediated killing of CD20-expressing cells

SubQ Ph 1/2 trials in B cell malignancies ongoing

50:50 co-development Genmab and AbbVie

15

Epcoritamab: Dose Escalation Data Presented at EHA25 Virtual Congress 2020*

Anti-tumor activity

  • 86% ORR in FL ≥ 0.76mg
  • 60% ORR, incl. 3 pts who failed prior CAR-T treatment, in DLBCL/HGBCL ≥12 mg
  • Emerging prelim. data highly encouraging with substantial single-agent efficacy
  • Induces rapid and deep responses in heavily pretreated pts with B-NHL across different subtypes

Safety

  • No DLTs observed; MTD has not been reached
  • No treatment-related deaths
  • No discontinuation due to AEs unrelated to disease progression
  • No Grade ≥ 3 CRS events observed

T cell

Target

B cell

CD3

CD20

Cytotoxic

activity

Dose-escalation data with subcutaneous epcoritamab indicate potential for best-in-class therapy

*Dose escaltion data presented on EHA25 Virtual Congress 2020 poster, Data cut-off dates: safety, April 24 2020; efficacy, May 14 2020

16

DuoHexaBody-CD37 (GEN3009)

Building Our Pipeline: First DuoHexaBody in the Clinic

Combination of DuoBody & HexaBody platforms

Novel target for hematologic malignancies

Unique mechanism-of-action

Dose escalation ongoing

50:50 co-development Genmab and AbbVie

17

DuoBody-CD3x5T4 (GEN1044)

Latest in the Clinic

Based on proprietary DuoBody technology

CD3 bispecific, T cell mediated cytotoxicity of 5T4+ tumor cells

5T4 expressed on multiple solid tumors limited expression in healthy tissue

Dose-escalation ongoing

50:50 co-development Genmab and AbbVie

18

DuoBody-PD-L1x4-1BB (GEN1046)

Bispecific Next Generation Checkpoint Immunotherapy

First-in-Class Bispecific antibody targeting PD-L1 & 4-1BB (CD137)

Designed to activate T cells through conditional 4-1BBco-stimulation, while simultaneously blocking the PD1/PD-L1 axis

Combining T cell stimulation with checkpoint blockade

Ph 1/2 study ongoing in solid tumors

50:50 co-development Genmab and BioNTech

19

DuoBody-CD40x4-1BB (GEN1042)

Bispecific Agonistic Antibody

Bispecific antibody targeting CD40 & 4-1BB (CD137)

Conditionally activates T cells and APC in presence of CD40-expressing cells

Phase 1/2 study ongoing in solid tumors

50:50 co-development Genmab and BioNTech

See local country prescribing information for approved indications

20

HexaBody-DR5/DR5 (GEN1029)

First HexaBody in Clinical Development

Targets 2 distinct DR5 epitopes

HexaBody platform - DR5 clustering & DR5 agonist activity

First 100% Genmab-owned HexaBody product in clinic

Phase 1/2 study ongoing in multiple solid tumors

21

2020 Guidance: Recurring Revenue Growth and Focused Investments

Income

DKKM

~USDM*

Key Observations

Statement

Revenue

9,250

- 9,850

1,423

- 1,515

Operating Expenses

(3,850)

- (3,950)

(592)

- (608)

Operating Income

5,350

- 5,950

823 - 915

Summary P&L

  • DARZALEX royalties of ~DKK 4.1bn to ~DKK 4.5bn to drive recurring revenue growth
  • Nearly 90% of USD 750M upfront from AbbVie collab. recognized immediately
  • Growth in operating expenses driven by expanding and accelerating our clinical pipeline

DARZALEX Sales of USD 3.9bn - USD 4.2bn

  • Significant opportunity for growth in 1L MM market
  • SubQ DARZALEX approvals in H1 in U.S. & EU
  • Market share gain in the U.S. and RoW driven by uptake in all lines of treatment
  • 8 approved indications in U.S., late stage to 1L MM

22

*2020 Guidance - November 4, 2020 / USD 1.00 = DKK 6.50.

Key 2020 Priorities

Building a Strong Differentiated Product Pipeline

Priority

Targeted Milestones

Genmab proprietary*

» Tisotumab vedotin1 - Phase 2 innovaTV 204 safety & efficacy analysis in recurrent/metastatic

products

**

cervical cancer and engage U.S. FDA for BLA submission subject to trial results

» Tisotumab vedotin - data on other solid tumor types

» Enapotamab vedotin - data to support late stage development

» Epcoritamab (DuoBody-CD3xCD20)2 Phase 1/2 - decision on recommended Phase 2 dose &

initiate expansion cohorts

» HexaBody-DR5/DR5 Phase 1/2 - advance dose escalation

» DuoBody-PD-L1x4-1BB3 Phase 1/2 - initiate expansion cohorts

» DuoBody-PD-L1x4-1BB initial data in H2 2020

» File INDs and/or CTAs for 2 new products

Daratumumab4

» U.S. FDA and EMA decision on Phase 3 COLUMBA multiple myeloma SubQ submission

» sBLA and MAA Submission Phase 3 ANDROMEDA amyloidosis

» sBLA and MAA submission Phase 3 APOLLO multiple myeloma

Ofatumumab5

» U.S. FDA decision on regulatory dossier submission in multiple sclerosis

Teprotumumab6

» U.S. FDA decision on Phase 3 OPTIC active thyroid eye disease submission

*Certain product candidates in development with partners, as noted.

23

**Data anticipated in 2021

1. 50:50 dev. w/ Seattle Genetics; 2. 50:50 dev w/ AbbVie; 3. 50:50 dev. w/ BioNTech; 4. In dev. by Janssen; 5. In dev. by Novartis; 6. In dev. by Horizon Therapeutics

Delivering on Genmab's Promise:

Innovating Antibodies, Improving Lives

Developing new capabilities to bring own product to market

Pipeline of 1st-in-class /best-in- class therapies advancing through clinic

World-class team with track record of success

Creating

Substantial

Value

Unique R&D engine &

Significant earnings potential

from marketed products

strategic alliances

24

Innovating Antibodies, Improving Lives

Appendix

A Leading International Biotech With Large Free Float

Approx.

Approx. Warrants

ADSs, Nasdaq

Market Cap*

Global Select

DKK 151bn

outstanding*:

USA

USD ~24bn

985,691 (~2%)

Ordinary

Shares

Shares

Diluted shares:

shares Nasdaq

world-wide incl:

outstanding*:

~66M

Copenhagen, DK

USA, UK, DK, NL

~65M

As of September 30, 2020

26

Genmab & AbbVie: Collaboration Overview

A broad, long-term oncology collaboration with Genmab and AbbVie working together to jointly make all strategy, clinical development and commercialization decisions

*Source: Company information and filings.

50/50 partnership across three clinical next- generation bispecific antibody product candidates (epcoritamab, DuoHexaBody-CD37,DuoBody-CD3x5T4)

Genmab to book epcoritamab sales in the U.S. and Japan; AbbVie to commercialize epcoritamab RoW - Genmab to receive tiered royalties on RoW net sales

Worldwide co-commercialization and profit split of all other programs

Discovery Research Collaboration

Fourth* largest oncology partnership with total

potential value ~USD 3.9bn (up-front cash +

milestone payments) to Genmab

27

Advancing Pipeline: Delivering on Our Promise & Creating Value

Accelerating Development of Potential "Next Winners"

Delivering on Genmab's Promise to Patients

DuoBody-CD3xCD20 (epcoritamab)

  • Potential best-in-class:SubQ administration
  • Pre-clinical /preliminary clinical data shows encouraging safety & efficacy
  • Expeditious and comprehensive clinical development plan
  • RP2D decision & expansion cohorts initiation
  • 50:50 AbbVie

DuoBody-PD-L1x4-1BB (GEN1046)

  • Potential first-in-class:Next generation IO
  • Unmet medical need
  • FiH clinical study: escalation phase is ongoing
  • 50:50 BioNTech

Track Record of Success

28

Advancing Pipeline: Delivering on Our Promise & Creating Value

Delivering on Genmab's Promise to Patients

Bolstering early stage portfolio

•DuoBody-CD40x4-1BB1;DuoHexaBody-CD372;DuoBody-CD3x5T42;HexaBody-CD383

Adding new technologies

Data sciences

Expanding early stage discovery programs

Enhancing clinical development capabilities

Track Record of Success

29

1GEN1042, 50:50 w/ BioNTech; 250:50 w/ AbbVie; 3Genmab is developing HexaBody-CD38 in an exclusive worldwide license and option agreement w/ Janssen Biotech, Inc

Genmab's Commitment to Society

Building a Socially Responsible & Sustainable Company

Anchored in our Core Purpose

CSR Committee comprised

Focus on four main areas

of representatives from

& Vision

variety of functions, chaired by

CEO

• To improve the lives of

• Ensures that Genmab carries

• Employee well-being, including

patients by creating and

out CSR activities effectively

health, safety & development

developing innovative

& communicates clearly and

• Ethics in relation to pre-clinical

antibody products

openly

and clinical studies

• By 2025 our own product has

• Focus on Environment,

• Environment, including waste

transformed cancer

Society and Governance

management & recycling

treatment and we have a

reporting

• Business ethics & transparency

pipeline of knock-your-socks-

off antibodies

30

Innovation Powerhouse:

Cutting Edge Proprietary Technologies

Technology

Principle

Applications

DuoBody

Bispecific antibodies

Dual targeting

HexaBody

Target-mediated

Enhanced potency

enhanced hexamerization

DuoHexaBody

Bispecific antibodies with target-

Dual targeting +

mediated enhanced

enhanced potency

hexamerization

HexElect

Two co-dependent antibodies

Dual targeting +

with target-mediated enhanced

enhanced potency & selectivity

hexamerization

31

Innovative Clinical and Pre-Clinical Pipeline

Genmab's Proprietary1 Products

Product

Target

Developed By Disease Indications

Most Advanced Development Phase

Pre-Clinical

1

1/2

2

3

Approved

Tisotumab vedotin

TF

50:50 Genmab

Cervical cancer

/ Seattle

Genetics

Ovarian cancer

Solid tumors

Enapotamab vedotin

AXL

Genmab

Solid tumors

Epcoritamab

CD3, CD20

50:50 Genmab

Hematological malignancies

(DuoBody-CD3xCD20)

/ AbbVie

DuoBody-PD-L1x4-1BB

PD-L1,

50:50 Genmab

Solid tumors

(GEN1046)

4-1BB

/ BioNTech

HexaBody-DR5/DR5

DR5

Genmab

Solid tumors

(GEN1029)

DuoBody-CD40x4-1BB

CD40,

50:50 Genmab

Solid tumors

(GEN1042)

4-1BB

/ BioNTech

DuoHexaBody-CD37

CD37

50:50 Genmab

Hematologic malignancies

(GEN3009)

/ AbbVie

DuoBody-CD3x5T4

CD3, 5T4

50:50 Genmab

Solid tumors

(GEN1044)

/ AbbVie

IND/CTAs in 2020

Genmab

HexaBody-CD38 (GEN3014)2

32

1Certain product candidates in development with partners, as noted. 2Genmab is developing HexaBody-CD38 in an exclusive worldwide license and option agreement with Janssen Biotech, Inc

Products Created by Genmab*

Including Proposed Label Expansions for Marketed Products

Product

Target

Developed By

Disease Indications

Most Advanced Development Phase

Pre-Clinical

1

1/2

2

3

Approved

DARZALEX

CD38

Janssen (Tiered

(daratumumab) &

royalties to Genmab

DARZALEX

on net global sales)

Multiple myeloma1

FASPRO

(daratumumab and

hyaluronidase-fihj)

Daratumumab

AL Amyloidosis

Non-MM blood cancers

Kesimpta

CD20

Novartis (Royalties

(ofatumumab)

to Genmab on net

Relapsing multiple sclerosis1

global sales)

Arzerra

CD20

Novartis

Chronic lymphocytic leukemia1,2

(ofatumumab)

TEPEZZA

Horizon

(teprotumumab-trbw)

Therapeutics (under

IGF-1R

sublicense from

Thyroid eye disease1

Roche, royalties to

Genmab on net global sales)

Teprotumumab

Diffuse cutaneous systemic sclerosis

*Out-licensed products marketed by partner 1See local country prescribing information for precise indications, 2Not in active development

Partner-owned Products Incorporating Genmab's Innovation*

Product

Target

Developed By

Disease Indications

Most Advanced Development Phase

Pre-Clinical

1

1/2

2

3

Approved

Amivantamab

EGFR, cMet

Janssen

(JNJ-61186372)

Teclistamab

BCMA, CD3

Janssen

(JNJ-64007957)

PRV-015

IL-15

Provention Bio

(AMG 714)

Camidanlumab tesirine

(ADCT-301)

CD25

ADC Therapeutics

Mim8

FIX(a), FX

Novo Nordisk

Talquetamab

GPRC5D, CD3

Janssen

(JNJ-64407564)

JNJ-63709178

CD123, CD3

Janssen

JNJ-63898081

PSMA, CD3

Janssen

JNJ-67571244

CD33, CD3

Janssen

JNJ-70218902

Undisclosed

Janssen

HuMax-IL8

IL8

BMS

Lu AF82422

alpha-Synuclein

Lundbeck

Non-small-cell lung cancer

(NSCLC)

Relapsed or refractory MM

Celiac disease

Relapsed /Refractory Hodgkin

Lymphoma

Solid tumors

Healthy volunteers & hemophilia A

Relapsed or refractory MM

Acute Myeloid Leukemia (AML)

Solid tumors

Relapsed or refractory AML or

MDS

Solid tumors

Advanced cancers

Parkinson's disease

34

*Out-licensed Products under development by a third-party incorporating Genmab technology and innovation

Solid Foundation Built on a Differentiated Pipeline

Tisotumab Vedotin Clinical Program

innovaTV 204

Recurrent or metastatic

cervical cancer

  • Potentially registrational 102 pts
  • Single arm, monotherapy
  • 1° endpoint: confirmed ORR
  • 2° endpoints: duration of response, PFS, OS

innovaTV 205

Recurrent or metastatic

cervical cancer

• In combo or mono

w/ bevacizumab, pembrolizumab, or carboplatin or weekly monotherapy recurrent or stage IVB cervical cancer

  • Up to 170 pts
  • 1° endpoint: ORR
  • 2° endpoints: Safety, duration of response, time to response,
    PFS, OS

innovaTV 207

Solid tumors

  • Basket study
  • Up to 250 pts
  • Single arm, monotherapy
  • 1° endpoint: ORR
  • 2° endpoints: Safety, disease control rate, duration of response, time to response,
    PFS, OS

innovaTV 208

Ovarian cancer

  • Ovarian cancer, fallopian tube cancer, peritoneal cancer
  • Up to 182 pts, incl 12 pt safety run-in
  • Monotherapy
  • 2 schedules: q3wk & dose dense
  • 1° endpoints: Safety & ORR

35

Tisotumab Vedotin

Cervical Cancer Market Size

United States3

Japan6

Europe2

New Diagnoses

Deaths

New Diagnoses

Deaths

New Diagnoses

Deaths

12,578

4,115

9,390

3,654

58,373

24,404

3rd most common gynecologic

2nd most common gynecologic

3rd most common gynecologic

cancer in US4

cancer in Japan6

cancer in Europe2*

In developed countries, incidence rates are low (<7.9 per 100,000 women) compared with developing countries in sub-Saharan Africa and Central and South America, where incidence is especially high (>30 per 100,000 women)5

*Europe is defined as the 40 countries in the four United Nations-defined areas of Europe and the European Union (EU-27).

References: 1. American Cancer Society 2. .EUCAN (2012) 3. Centers for Disease Control and Prevention. Cervical Cancer Statistics (2017) 4. UpToDate.

36

5. Ginsburg O et al. Lancet 2017 6. HPV Information Centre Japan (2017)

HexaBody-CD38 (GEN3014)

Expanding the Potential of CD38 Antibodies

Incorporates

Highly promising

Could potentially

IND/CTA planned

proprietary

data pre-clinical

add to and broaden

in H2 2020

HexaBody

models for MM,

DARZALEX

technology

lymphoma & AML

franchise

37

Covering All Stages of MM and Beyond: Key Ongoing* Industry Sponsored Trials

Disease

High Risk Smoldering MM

Front line MM (transplant & non- transplant)

Relapsed or Refractory MM

ALL

Therapy

Subcutaneous

Monotherapy

Dara + VRd

Dara + VMP (Asia Pacific)

Dara + VRd

Dara + R (maintenance)

Dara + combinations

Dara + I.O. (PD1 & PDL1)

Dara + SoC chemo

Development Phase

Pre-Clinical

1

1/2

2

3

AQUILA

CENTAURUS

CEPHEUS

OCTANS

PERSEUS

AURIGA

NINLARO® (Ph II), Venclexta® (Ph II), Selinexor

(Ph I/II)

Opdivo® (Ph I/II), Tecentriq® (Ph I)

DELPHINUS

V = Velcade® , MP = melphalan-prednisone , T = thalidomide d = dexamethasone, R = Revlilmid®, K = Kyprolis®, Pom = Pomalyst®

  • Fully recruited

*Does not include trials that may still be ongoing but have clinical data and/ or

38

are the basis for an existing approval.

Daratumumab Efficacy in Newly Diagnosed Multiple Myeloma

Updated Phase 3 MAIA Trial (D+Rd, NTE): ASH Dec 2019

• Median PFS not reached in D-Rd arm

• MRD-negativity significantly higher with D-Rd vs. Rd (29% vs 9%; P<0.0001)

• No new safety concerns

• Results continue to support use of D-Rd in 1st line treatment of TIE pts with NDMM

39

D = daratumumab; R = lenalidomide; d = dexamethasone; PFS = progression free survival; MRD - minimal residual disease

Ongoing Daratumumab Clinical Trials

Janssen Sponsored Phase 3 & 4

Daratumumab Trials Sponsored by Pharma / Biotech

Ct.gov Identifier

Phase

Sponsor

Indication

Therapy

NCT03768960

4

J&J Private Ltd

Relapsed or Refractory MM

Daratumumab (MMY4008)

NCT02252172

3

Janssen

Untreated MM

Daratumumab + Rd (MAIA)

NCT02195479

3

Janssen

Untreated MM

Daratumumab + VMP (ALCYONE)

NCT02541383

3

Janssen

Untreated MM

Daratumumab + VTd (CASSIOPEIA)

NCT02076009

3

Janssen

Relapsed or Refractory MM

Daratumumab + Rd (POLLUX)

NCT02136134

3

Janssen

Relapsed or Refractory MM

Daratumumab + Vd (CASTOR)

NCT03180736

3

Janssen

Relapsed or Refractory MM

Daratumumab + Pom-d (APOLLO)

NCT03201965

3

Janssen

Amyloidosis

Daratumumab + CyBorD (ANDROMEDA)

NCT03217812

3

Janssen

Untreated MM

Daratumumab + VMP (Asia Pacific) (OCTANS)

NCT03234972

3

Janssen

Relapsed or Refractory MM

Daratumumab + Vd vs Vd (LEPUS)

NCT03277105

3

Janssen

Relapsed or Refractory MM

Daratumumab SubQ vs IV (COLUMBA)

NCT03301220

3

Janssen

Smoldering MM

Daratumumab SubQ (AQUILA)

NCT03652064

3

Janssen

Untreated MM

Daratumumab + VRd (CEPHEUS)

NCT03710603

3

Janssen/EMN

Untreated MM

Daratumumab + VRd (PERSEUS)

NCT03901963

3

Janssen

Untreated MM / Maintenance

Daratumumab + R (AURIGA)

40

Ongoing Daratumumab Clinical Trials

Janssen Sponsored Phase 1 & 2

Daratumumab Trials Sponsored by Pharma / Biotech

Ct.gov Identifier

Phase

Sponsor

Indication

Therapy

NCT03384654

2

Janssen

Relapsed / Refractory ALL / LL

Dara + Vincristine + Prednisone + Doxorubicin (DELPHINUS)

NCT02951819

2

Janssen

Untreated and Relapsed MM

Daratumumab + CyBorD (LYRA)

NCT02874742

2

Janssen

Untreated MM

Daratumumab + VRd (GRIFFIN)

NCT02316106

2

Janssen

Smoldering MM

Monotherapy (CENTAURUS)

NCT02927925

2

Janssen

NKTCL, Nasal Type

Monotherapy (VOLANS)

NCT03412565

2

Janssen

Newly diag. & relapsed / refractory MM

Daratumumab SubQ + Rd, VMP & VRd (PLEIADES)

NCT03871829

2

Janssen

Dara retreatment

Daratumumab SubQ+ Kd vs Kd (LYNX)

NCT03011034

2

Janssen

MDS

Daratumumab (or talacotuzumab) (MDS2002)

NCT01615029

1/2

Janssen

Relapsed and Refractory MM

Daratumumab + Rd (GEN503)

NCT02852837

1

Janssen

Relapsed or Refractory MM

Monotherapy (in China) (MMY1003)

NCT02519452

1

Janssen

Relapsed or Refractory MM

Monotherapy, subcutaneous (PAVO)

NCT02918331

1

Janssen

Untreated MM

Daratumumab + Rd (Japan) (MMY1006)

NCT03242889

1

Janssen

Relapsed or Refractory MM

Daratumumab subq (Japan) (MMY1008)

NCT01998971

1

Janssen

Various MM

Daratumumab + backbone regimens (Vd, VMP, VTd, Pom-d, Kd, KRd)

(EQUULEUS)

NCT04108195

1

Janssen

Multiple Myeloma

Daratumuamb + either talquetamab or teclistamab (MMY1002)

NCT04121260

1

Janssen

Multiple Myeloma

Subcutaneous monotherapy (in China) (MMY1010)

41

Ongoing Daratumumab Clinical Trials

Other Industry Sponsored Trials

Daratumumab Trials Sponsored by Pharma / Biotech

Ct.gov Identifier Phase

Sponsor

Indication

Therapy

NCT03158688 3

NCT01946477 2

NCT02807454 2

NCT03439293 2

NCT03314181 2

NCT02807558 2

NCT02773030 1/2

NCT02343042 1/2

NCT03481556 1/2

Amgen

Relapsed or Refractory MM

Celgene

Relapsed or Refractory MM

Celgene

Relapsed and Refractory MM

Takeda

Relapsed or Refractory MM

AbbVie

Relapsed or Refractory MM

Syros Pharma

AML or MDS

Celgene

Relapsed or Refractory MM

Karyopharm

Relapsed or Refractory MM

Oncopeptides

Relapsed or Refractory MM

AB

Daratumumab + Kd (CANDOR)

Daratumumab + Pom-d

Daratumumab + Imfinzi (FUSION)

Daratumumab + NINLARO (ixazomib) + Dex

Daratumumab + Venetoclax + Dex (w/ or w/out bortezomib) Daratumumab + SY-1425

Daratumumab + CC-220 + Dex

Daratumumab + Selinexor + Dex (STOMP)

Daratumumab + Melflufen + Dex (ANCHOR)

NCT01592370

1/2

BMS

Relapsed or Refractory MM

NCT03837509

1/2

Incyte

Relapsed or Refractory MM

NCT03989414

1/2

Celgene

Various MM

NCT02431208

1

Roche

Resistant or Refractory MM

NCT03068351

1

Roche

Resistant or Refractory MM

NCT04045028

1

Genentech

Relapsed or Refractory MM

NCT04136756

1

Nektar Thera.

Salvage for MM

Daratumumab + nivolumab

Daratumumab + INCB001158

Daratumumab + CC-92480

Daratumumab + Tecentriq (atezolizumab)

Daratumumab + RO6870810

Daratumumab + tiragolumab

Daratumumab + NKTR-255

42

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Genmab A/S published this content on 03 November 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 04 November 2020 20:15:09 UTC