MorphoSys AG Meet The Team · MorphoSys AG Meet The Team The Yale Club, New York June 25, 2019

MorphoSys AG

Meet The Team

The Yale Club, New York

June 25, 2019

2© MorphoSys AG | Meet the Team | June 25, 2019

This presentation includes forward-looking statements.

This communication contains certain forward-looking statements concerning the MorphoSys group of companies, including its financial guidance for 2019,

the commencement, timing and results of clinical trials and release of clinical data both in respect of its proprietary product candidates and of product

candidates of its collaborators, the development of commercial capabilities, in particular with respect to tafasitamab (MOR208) and the transition of

MorphoSys to a fully integrated biopharmaceutical company, interaction with regulators, including the potential approval of MorphoSys’s current or future

drug candidates, including discussions with the FDA regarding the potential approval to market tafasitamab, the expected time of launch of tafasitamab,

and expected royalty and milestone payments in connection with MorphoSys’s collaborations. The forward-looking statements contained herein represent

the judgment of MorphoSys as of the date of this release and involve known and unknown risks and uncertainties, which might cause the actual results,

financial condition and liquidity, performance or achievements of MorphoSys, or industry results, to be materially different from any historic or future

results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if

MorphoSys’s results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such

forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are

that MorphoSys’s expectations regarding its 2019 results of operations may be incorrect, MorphoSys’s expectations regarding its development programs

may be incorrect, the inherent uncertainties associated with competitive developments, clinical trial and product development activities and regulatory

approval requirements (including that MorphoSys may fail to obtain regulatory approval for tafasitamab and that data from MorphoSys’s ongoing clinical

research programs may not support registration or further development of its product candidates due to safety, efficacy or other reasons), MorphoSys’s

reliance on collaborations with third parties, estimating the commercial potential of its development programs and other risks indicated in the risk factors

included in MorphoSys’s Annual Report on Form 20-F and other filings with the US Securities and Exchange Commission. Given these uncertainties, the

reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of

publication of this document. MorphoSys expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any

change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may

affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or

regulation.

The compounds discussed in this slide presentation are investigational products being developed by MorphoSys and its partners and are not currently

approved by the U.S. Food and Drug Administration (FDA), European Medicine Agency (EMA) or any other regulatory authority (except for

guselkumab/Tremfya®). Any shown cross-trial comparison between MorphoSys-own investigational products and literature data have significant

limitations. Such data comparisons have been prepared at the request of, and for the sole benefit of, the investor community.


AGENDA

David Trexler: U.S. Commercialization2.

Nuwan Kurukulasuriya: Medical Affairs Outreach 3.

Simon Moroney: Company Overview1.

Jens Holstein: Financial Strategy

Malte Peters: L-MIND Primary Analysis Data

Q&A Session

4.

5.

6.


Engineering the Medicines of Tomorrow

Simon Moroney, Chief Executive Officer

Meet the Team | June 25, 2019
























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6

Effective on September 1, 2019

© MorphoSys AG | Meet the Team | June 25, 2019

New CEO Dr. Jean-Paul Kress

Over 20 years in the pharmaceutical and

biotechnology industry, with a strong track record

of commercial and operational leadership in North

America and Europe

Prior senior management roles include

Syntimmune: Chief Executive Officer

Biogen: Executive Vice President and Head of

Global Therapeutic Operations

Sanofi: Senior Vice President, Head of North

America at Sanofi Genzyme

Sanofi Pasteur MSD: President, CEO

Gilead: General Manager, France, and member

of the operating committee

Eli Lilly and Abbvie: Product management

M.D. degree from Faculté Necker-Enfants Malades

(Paris)

Graduate and post-graduate degrees in

pharmacology and immunology from École Normale

Supérieure (Paris)

7

Develop the medicines of tomorrow to improve the lives of patients

suffering from serious diseases


Our Mission


We are at an inflection point on the way to becoming

a fully integrated biopharmaceutical company

9

Leveraging our clinical assets to anchor a new growth trajectory


Strong Clinical Pipeline

Segment revenues

2018

Partnered Discovery

23 clinical candidates

25 programs in preclinic

58 programs in discovery

Valu

e

Business transformation

~€54 million

~€23 million

Segment revenues

2018

Proprietary Development

5 clinical candidates

1 program in preclinic

6 programs in discovery

Tremfya®

MOR106

MOR103

MOR202

tafasitamab

10

An ENFORCER™ antibody


Tafasitamab

tafasitamab

ENFORCER™

Enhanced Format for Cancer Eradication

Fc-engineered to address:

Increased recruitment of effector cells

Enhanced elimination of cancer cells

11

NHL – Non-Hodgkin lymphoma CLL – Chronic lymphotic leukemia ALL – Acute lymphoblastic leukemia

Assessing the clinical potential of our key proprietary asset


Tafasitamab Value Proposition

Chemo-free regimen aiming to improve

quality of life and outcome for patients

43% complete response rate

21.7 months duration of response

Data support overall survival outcome

ENFORCER™ goal to drive effective immune-mediated killing of malignant B cells

Demonstrated activity with lenalidomide

Single agent activity shown in other

forms of NHL, CLL & B-ALL

Readily combined with other agents

Opportunity to develop broadly

DLBCL Other B cell malignancies

12

Addressing different treatment approaches with L-MIND and B-MIND


Tafasitamab Clinical Trials in DLBCL

Tafasitamab + bendamustine

vs.

rituximab + bendamustine

Tafasitamab + lenalidomide

vs.

virtual lenalidomide-only

L-MIND B-MIND

Phase 2, open-label, single-arm trial

Virtual lenalidomide-only comparator arm

Compelling primary analysis data

Study ongoing with responding patients

Chemo-free regimen

Phase 2/3, randomized, multicenter trial

Biomarker subgroup: ~50% of patients

Futility analysis H2 2019

1. All-comers pass futility

Final data Q1 2020 (330 patients)

2. Only subgroup passes futility

Final data Q1 2021 (450 patients)

3. All-comers and subgroup fail futility

Study is futile

Different

combinations

Combination with an

immuno-modulatorCombination with a

chemotherapeutic

Different

modes of action

13

U.S. Commercial Strategy

Create U.S. hub to accelerate market uptake

Regulatory Strategy Framework

Pursue regulatory approval for tafasitamab in U.S. and EU

Setting a trajectory for greater value creation


Corporate Strategy

Clinical Development Direction

Seize tafasitamab opportunities to drive sustainable growth

Partnering

Maximize the value of our key asset

14

MorphoSys US Inc. located at Boston Harbor


MorphoSys U.S. Subsidiary

Located in the heart of the U.S. No. 1 Life

Sciences Cluster

Highly attractive to best-in-class talent

Strategic position for direct U.S. market access

15

L-MIND:

Breakthrough Therapy Designation granted in 2017

Close alignment with the FDA - minimizing risks

FDA guidance on reasonable ways forward

Planned BLA submission by end of 2019

Earliest approval mid-2020

B-MIND:

Pre-planned interim analysis in H2 2019

BLA – Biologics license agreement

Pursue regulatory approval for tafasitamab in U.S. and EU


Regulatory Strategy

FDA progress and next steps

EMA progress and next steps

L-MIND:

First interactions with national health authorities

Submitted request for scientific advice to EMA

16

Maximizing the value of tafasitamab with the best possible deal


Partnering Tafasitamab

Tafasitamab

Our flagship

asset

Strong interest based

on compelling clinical

data

Good chance for favorable regulatory

path in Europe – significant impact on

value of program

Focusing on exclusive

MorphoSys U.S. rights

In discussions with

interested parties

17

Key strategic directions for next wave of clinical trials


Clinical Development Direction

Position tafasitamab in competitive environment

Seize front-line DLBCL opportunities for tafasitamab

Go broad and deepin r/r DLBCL

Initiate development in other, non-DLBCL indications


Summary

Well on track with our goal to transform into

a fully integrated biopharmaceutical company

MorphoSys is set to become a key player

in the oncology field in the U.S.

Driving clinical assets development to enhance

proprietary pipeline product value

SUMMARY


David Trexler, President MorphoSys US Inc.

























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21

Strong history of top level performance


Commercial Leadership

David Trexler

President of MorphoSys US Inc.

33 year track record in building commercial capabilities

for international pharmaceutical companies

Prior positions as SVP Oncology Commercial for EMD

Serono/Merck KGaA building first commercial oncology

footprint in the U.S. and launching the first PD-L1

antibody for mMCC. Other positions, including Eisai Inc,

being responsible for commercial strategies, supporting

Aloxi®, Dacogen®, Halaven® and Lenvima®

Deep knowledge of marketing, sales, market access

environment and business development

Focus on build-up of MorphoSys’s commercial capabilities

in preparation for the planned tafasitamab launch


We are building a strategic presence in

the world‘s most important pharmaceutical market

23

1) IQVIA MIDAS May 2018 2) IQVIA patient survey June 2018

Accelerated market uptake from U.S. hub


U.S. Commercialization Strategy

U.S. Market Size1)

64% of sales of all new medicines

launched between 2012-2017

48% of global sales (~$853 bn) in 2017

Large Oncology Network2)

Top 10 U.S. states contain 56% of all

DLBCL patients and 55% of all treaters

24

Building the tafasitamab value chain between the U.S. and Europe


Leveraging Synergies

Contributing strong commercial expertise

U.S. Head of Market Access and Policy

U.S. Marketing and Sales

U.S. Medical Affairs

Munich

Boston

MorphoSys AG

MorphoSys US Inc.

Contributing strong technology expertise

Global Head of Supply Chain Management

Global Head of Regulatory

Antibody material produced in Germany

Packaging of tafasitamab planned in Europe

25

Laying a foundation for the anticipated launch of tafasitamab in the U.S.


U.S. Commercial Strategy

Functional Commercial Structure

Filling critical positions by hiring talents with deep expertise

Targeted Market Access and Policy Approach

Securing timely and appropriate access to tafasitamab

>200

Commercial Operations Build-up

Providing an operational foundation to enable market access

Sales and Marketing Approach

Position tafasitamab as potential new standard of care

in r/r DLBCL

26

Filling critical positions by hiring talent with deep expertise


Functional Commercial Structure

Medical Affairs

Nuwan Kurukulasuriya

Market Access and Policy

Chris Mancill

Legal

Ben Looker

Finance

Chris Krawtschuk

Commercial Operations

Krishna Kadiyala

Sales and Marketing

Stephane Berthier

President

MorphoSys US Inc.

David Trexler

27

Recruiting top talent to build a function fit for strong launch


Top Talent

25 years experience in market access, policy,

and pricing at the global and U.S. levels

Prior positions with numerous biopharmaceutical

companies, including Amgen and EMD Serono/Merck KGaA

Proven track record of securing access for innovative

oncology products, matching the buy-and-bill, HCP-

administered profile of tafasitamab

Deep experience in oncology and hematology launches

across a large variety of indications and tumor types

Chris Mancill

Senior Vice President and Head

of Market Access and Policy

28

HCP – Health care professionals CMS – Centers for Medicare & Medicaid

Striving to enable access to tafasitamab for all eligible patients


Strategic Imperatives

Market Approach Policy Approach

Make tafasitamab easily available to HCPs

in community and academic settings

Ensure payer awareness through targeted pre-

approval engagement and secure CMS coding

Address barriers among HCPs to grant

timely patient access

Support appropriate patient access with financial

and other patient support resources

Brand MorphoSys as a responsible partner

in addressing policymaker’s priorities

Embed advocacy community perspectives

into the commercialization plan

Understand the pricing and reimbursement

landscape to inform launch plans

Ensure that stakeholder views are considered

in our patient access and support approach

29



Top Talent

14 years experience in creating value with

commercial operations and advanced analytics

Prior positions in a variety of biopharmaceutical

companies, including Spectrum, Novartis and Merck

Proven track record of developing commercial strategies

for maximizing short- and long-term value of the brand

Deep experience in oncology and hematology launches

across a variety of indications and tumor types

Krishna Kadiyala

Vice President and Head of

Commercial Operations and

Innovation

30

Laying a solid operational foundation to enable market access



Commercial building blocks

Enable sales and marketing to increase awareness

of tafasitamab among customers and patients

Implement cutting-edge technology and advanced

analytics to create competitive advantage

Deliver solutions to decrease barriers to adoption

Develop and continuously improve sales

management processes through innovation

Commercial Operations

Execute on roadmap for market segmentation

and sales force size and structure

Evaluate commercial technologies to enable

multiple sales and marketing touch points

Build commercial analytics function to shape

commercial strategy, life cycle management,

and resource allocation decisions

31



Top Talent

20 years experience in global and U.S. sales & marketing

and global research & development

Prior positions at Novartis and at Janssen where being

responsible for the Imbruvica® franchise

Strong scientific and business qualifications and proven

track record of leading sales & marketing teams and cross-

functional teams

Deep expertise in oncology and hematology with more

than 15 year experience in developing, launching and

maximizing drugs

Stephane Berthier

Vice President and Head of

Sales and Marketing

32

1) Subject to approval HCP - Healthcare professionals

Establish tafasitamab as potential new standard of care in r/r DLBCL1)



Sales and Marketing Approach

Support quick adoption of tafasitamab

at launch

Establish tafasitamab + lenalidomide as

potential standard of care in r/r DLBCL1)

Institute treat-to-progression in r/r DLBCL

Set up MorphoSys as a strong partner to key

oncology accounts and institutions

High performing field force communicates value of

tafasitamab and overcomes early access challenges

Tafasitamab + lenalidomide intended to allow for

convenient and long term disease control for

patients and HCPs

Tafasitamab + lenalidomide tolerability implies

potential benefit on long term treatment efficacy

Be seen by all stakeholders as a reliable

company caring for the needs of their patients


Summary

Building-up of an efficient organization to prepare

for a potential U.S. launch of tafasitamab

Tapping the full potential of MorphoSys by addressing

the world’s most important pharmaceutical market

Creating an environment that attracts, develops

and retains best-in-class talent

SUMMARY


Nuwan Kurukulasuriya, Senior Vice President Head of Global Medical Affairs

























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36

Executing a multi-stakeholder medical engagement strategy


Medical Affairs

Nuwan Kurukulasuriya

Senior Vice President

Head of Global Medical Affairs

20 years of academic, medical affairs and clinical

development experience

Prior positions at Johnson & Johnson, EMD Serono/Merck

KGaA, Biogen and Shire leading medical affairs teams and

providing portfolio-wide oversight of launch strategies

As Head of Medical Research and RWE and member of

Biogen’s Global Medical Affairs Leadership Team,

co-engineered Medical-Marketing-Market Access launch

strategies; successfully launched Tecfidera®, now

generating $4bn in annual revenues

As VP Head US Medical Affairs at Shire led large teams

across multiple therapeutic areas including hematology,

oncology, immunology, neurology, ophthalmology and

rare diseases


We are building a strong patient-centric medical

organization as a conduit to the oncology community

38

Launching tafasitamab to become the potential new standard of care in r/r DLBCL


Medical Affairs Strategy

Evidence-based Scientific and Value Narrative

Differentiating on long-term clinical and cost effectiveness

Launching investigator and company sponsored studies

Outreach and Awareness

Dynamic mapping, field-validation and engagement of KOLs

Dual academic medical center and community focus

>200

Informing Real World Clinical Practice

Optimized treatment sequencing within DLBCL

Improve patient outcomes

39

Multi-stakeholder, multi-channel engagement


Communicating with Impact

40

May 2019 June 2019

ISPORASCO

EHA

ICML

Poster + Dr Johannes Dull,

L-MIND data showcase

Poster:

MOR208 + LEN

event simulation model

ICML L-MIND

platform presentation

Emphasizing clinical and cost effectiveness


Relaying the Tafasitamab Value Story

41

Medical affairs immersive booth

Competitor and congress intelligence to inform insights

Poster and oral presentations

Multichannel social media communication campaign

Post-congress materials

for enduring resources

Pre-congress materials

+ teaser campaign

Engagement with third party channels

Leaving an impression – evolving our creative theme

Real-time reactions to data by KOLs

Connecting with customers via digital, multi-media science-campaign

Building a Runway to Launch Excellence


42

Hematologists/oncologists, patients and caregivers are key influencers on treatment


The DLBCL Care Community

Stakeholders Across the DLBCL Care Community

Payer

Social

worker

NurseTransplant

physician

Internal medicine

physician

Hematologist/

oncologist

Patient Caregiver

Office

managers

Pathway

developers

Patient advocacy

groups

Pro

vid

er

Pati

ent

Payer

& P

olicy

43

1) IQVIA for MorphoSys: U.S. Patient Journey, June 2018 KOL – Key opinion leader

Strategy to create awareness and establish extensive HCP and KOL network


Targeted U.S. Medical Affairs Outreach

Top 10 States

Texas Pennsylvania

California Illinois

Florida New Jersey

New York Arizona

Ohio Michigan

Treated Patient Range # of States

≥560-2,100 10

≥370-560 9

≥210-370 11

≥70-210 10

≥1-70 12

HCP Heat Map1)

56% of treating physicians are

located in top 10 U.S. states

44

1) IQVIA for MorphoSys: U.S. Patient Journey, June 2018

Strategy to reach majority of r/r DLBCL patients1)


Targeted U.S. Medical Affairs Outreach

50%25%0%

75%

100%

100%

25%

50%

0%

75%Num

ber

of

DLBCL

pati

ents

in t

he U

.S.

[%]

Number of hematologists/oncologists in the U.S. [%]

~1,300

hem/oncs

~2,000

hem/oncs

~2,400

hem/oncs

~1,100

hem/oncs

Focus on top ~2,400

hematologist/oncologists

covers ~75% of all DLBCL patients

45

Working toward a potential paradigm shift driven by strong clinically data


Access Through Medical Affairs

Pre-launch scientific engagement of key opinion

and thought leaders

Best balance academic medical center vs.

community oncology engagement

Partner with advocacy groups to elevate

awareness of ongoing clinical development

Dynamic field mapping of national and regional

patient advocacy groups

Integrated HEOR evidence generation to support

tafasitamab value story

Develop budget impact model, cost efficiency

model, network meta analyses mixed treatment

comparisons and patient preference study

Together with access and policy teams plan joint

interactions with CMS, Medicare Part B, Medicare

Advantage, IDNs and other payers

Clear and easily understandable value

proposition

Providers Patients

Payers Policy

HEOR - Health Economic and Outcomes Research CMS – Centers for Medicare and Medicaid Services IDN – Integrated Delivery Network


Summary

Clear understanding of the DLBCL stakeholder landscape

Compelling and competitive scientific-value narrative

Strong, diverse and agile Medical Affairs organization

SUMMARY


Jens Holstein, Chief Financial Officer

























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Our financial strength is the basis for our new

growth trajectory

50

1) Revenues are expected to include royalty income from Tremfya® ranging from EUR 23-30 million at constant USD exchange rate.

Well positioned to execute strategy and drive value


Key Financial Figures

In € million

FY 2018(As of March 13, 2019)

Q1 2019(As of May 7, 2019)

Guidance 2019 (As of March 13, 2019)

Group Revenues1) 76.4 13.5 43 to 501)

Proprietary R&D Expenses

(incl. Technology Development)98.3 22.6 95 to 105

EBIT -59.1 -23.6 -127 to -137

Cash position 454.7 431.2

Total ordinary shares issued as of May 31, 2019: 31,839,572


Financial Strategy

Solid Cash Position

Leverage increasing royalty streams and milestone

payments in the years to come

Prudent Capital Allocation

Invest in proprietary portfolio, especially tafasitamab

and U.S. commercial build-up

>200

First Proprietary Product Launch

Capture growth opportunities in global DLBCL by

intending to invest broader in tafasitamab

Prospective Cash Generation

Build on revenues from tafasitamab and partnered

product sales as well as partnering deals

€

52

Solid financial 2019 goals with further upside potential


Solid Cash Position

€454.7m

€43 - 50m

€95 - 105m

estimated

€70 - 80m

In €

million

~€320 - €330m

53

1) In € million

Invest in proprietary portfolio and U.S. commercial build-up1)


Prudent Capital Allocation

R&D Expenses Other Headquarter CostsTotal Costs Commercial Build-Up

Total FY 2018: €136.5m Total Q1 2019: €37.3m

106.4

23.17.0

24.7

5.57.1

54

1) Excluding potential partnering or in-licensing deal

Invest in proprietary portfolio and U.S. commercial build-up


Strategic Investments

€454.7m

Cash YE 2018 Cash YE 20201)

Revenues Prop. R&D Commercial G&A

+ Tremfya® sales

ramping up

+ Potential

tafasitamab

sales from 2020

- Proprietary

portfolio

- Clinical

development

- Commercial

build-up U.S.

- Preparation

for EU launch

- Maintain tight

cost control

~$90-100m to build

commercial capabilities

for tafasitamab (FY2018 to 2020)

+ – – –

Available for

broadening

of tafasitamab

55

1) Combined literature and analyst estimates

Capture growth opportunities in global DLBCL market



0

2

4

6

8

2018 2025 2027

In $

billion

Estimated Global DLBCL Market Size1)

Front-line Relapsed/refractory

~12% CAGR

56

1) Combined literature and analyst estimates (illustrative) 2) Subject to regulatory approval

Capture growth opportunities in global DLBCL market1)



2018 2020 2027

R-CHOP

Tafasitamab

other

Potential market share in 1st line DLBCL2)

Potential market share in 2nd line DLBCL2)

Intense regimens

Tafasitamab

other

Milder regimens

57

Source: DRG Epidemiology data; Kantar Market Research (TPP testing 2018), Friedberg et al., 2011

*Depending on label

Addressable U.S. market: ~10,000 patients as of 2018


Opportunity for Tafasitamab in r/r DLBCL

Patients treated

in 1st line (U.S.)

~31.800

~60% of all 1st line

patients cured

ASCT eligible

ASCT ineligible

~5.900

ASCT eligible

ASCT ineligible

~4.100~20%

relapsed

~20%

refractory

~10% of all 2nd line

patients cured

not treated not treated

1st Line 2nd Line 3rd+ Line

Potential

~10,000

Upside

Potential*

Upside

potential

UPDATE

58

Source: DRG Epidemiology data; Kantar Market Research (TPP testing 2018), Friedberg et al., 2011

*Depending on label

Addressable EU market: ~6,500 patients as of 2018


Opportunity for Tafasitamab in r/r DLBCL

Patients treated

in 1st line (EU5)

~20.730

~60% of all 1st line

patients cured

ASCT eligible

ASCT ineligible

~3.820

ASCT eligible

ASCT ineligible

~2.680~20%

relapsed

~20%

refractory

~10% of all 2nd line

patients cured

not treated not treated

1st Line 2nd Line 3rd+ Line

Potential

~6.500

Upside

Potential*

Upside

potential

EU5

59

Build on revenues from own and partnered product sales


Prospective Cash Generation

Milestones

payments and

Royalties from

Partnered Discovery

segment

Revenues

Proprietary

Development

segment

(tafasitamab)

2019 2020 2021+

Expansion

Proprietary

Development

segment

Potential for tafasitamab in further settings

(1st line DLBCL, additional indications)

Proprietary pipeline programs

and potential in-licensed projects

Vision: Adding compounds following

tafasitamab for commercialization

U.S. launch of tafasitamab in r/r DLBCL

mid-2020, subject to FDA approval

Preparation for tafasitamab EU approval

Group revenues in 2019 expected between

€43 to 50m


Summary

Increasing opportunities based on a significantly

growing global DLBCL market

Multiple cash flow contributions to support

broadening of tafasitamab

Solid financial position to fully explore and invest

in the value of our proprietary portfolio

SUMMARY

MorphoSys AG

Meet The Team

Short break - we will be right back


Malte Peters, Chief Development Officer

























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We are working toward our intention to transform into a

biopharmaceutical company supported by tafasitamab data

65

Cycle 12+Cycle 1-3 Cycle 4-12

* a loading dose of MOR208 was administered on day 4 of cycle 1

#Primary refractory DLBCL was defined as no response to or progression/relapse during or within 6 months of frontline therapy

Response assessment (Cheson 2007 Criteria) after cycles 2, 4, 6, 9 and 12, thereafter every 3 cycles.

ASCT, autologous stem cell transplant; HDC, high-dose chemotherapy; SD, stable disease, p.o., per os; LEN, lenalidomide

Phase 2, single-arm, open-label, multicenter study (NCT02399085)


L-MIND: Study Design of Tafasitamab/Lenalidomide

Primary endpoint

Overall response rate (ORR), central read

Secondary endpoints

Progression-free survival (PFS)

Duration of response (DoR)

Overall survival (OS)

Safety of the tafasitamab + LEN combination

Exploratory and biomarker-based analyses

Sample size suitable to detect ≥15% absolute increase in ORR

for tafasitamab/LEN combination vs. LEN monotherapy at 85%

power, 2-sided alpha of 5%

Mature Data: At time of primary endpoint analysis with data

cut-off 30 Nov 2018; minimum follow-up 12 months, median

follow-up 17.3 months

Lenalidomide25 mg/d p.o.

d 1-21

Tafasitamab12 mg/kg

q4w; d1, 8, 15, 22*

Tafasitamab12 mg/kg

q4w; d1, 15

Tafasitamab12 mg/kg

d1, 15

r/r DLBCL

1-3 prior regimens

not eligible for HDC

and ASCT

primary refractory

patients were to be

excluded

≥SD

until progression

66

*at study entry


Baseline Characteristics

Characteristic Specification n=81 (%)

SexMale

Female

44 (54)

37 (46)

Age [years]* median (range) 72 (41-86)

Risk (IPI)*0-2

3-5

40 (49)

41 (51)

Ann Arbor Stage*I-II

III-IV

20 (25)

61 (75)

Elevated LDH* Yes

No

45 (56)

36 (44)

Prior Lines

Median

1

2

3

4

2

40 (49)

35 (43)

5 (6)

1(1)

Primary RefractoryYes

No

15 (18)

66 (82)

Refractory to last prior therapy*Yes

No

36 (44)

45 (56)

Prior SCTYes

No

9 (11)

72 (89)

Cell of Origin

(Centrally assessed - Hans algorithm)

GCB

Non-GCB

Unknown

37 (46)

20 (25)

24 (30)

67

N=81; TEAEs, treatment-emergent adverse events, numbers represent % patients


Tafasitamab + Lenalidomide Safety Profile

7

9

3

11

10

11

9

3

9

9

15

8

15

12

15

12

21

11

11

1

4

5

10

4

5

5

5

9

6

4

5

6

5

10

6

9

11

6

3

16

1

3

4

3

5

6

1

1

3

1

10

7

12

7

27

1

1

1

3

1

5

21

0 10 20 30 40 50 60

Dyspnea

Vomiting

Bronchitis

Muscle spasms

Nausea

Constipation

Back pain

Urinary tract infaction

Fatigue

Hypokalaemia

Decreased appetite

Rash

Pyrexia

Oedema peripheral

Cough

Asthenia

Diarrhoea

Febrile neutropenia

Leukopenia

Thrombocytopenia

Anaemia

Neutropenia

Grade 1

Grade 2

Grade 3

Grade 4

Hematologic TAEs in ≥10% Patients

Non-hematologic TAEs in ≥10% Patients

37 patients (43%) required LEN dose reduction

62/80 patients (78%) were able to stay at dose ≥20mg/d

68

0%

50%

100%

ORR, overall response rate; CR, complete response; NE, not evaluable; PD, progressive disease; PR, partial response; SD, stable disease; CI, confidence interval; PET,

positron emission tomography; CT, computertomography

ORR 60.0% (95%CI: 48.4% - 70.8%)

CR-rate 42.5%

82% of CRs PET-confirmed

18% of CRs based on CT only

N=80: full analysis set patients receiving at

least one dose of Tafasitamab and LEN

NE due to missing post-baseline tumor

assessment


Primary Endpoint: Overall Response Rate (ORR) by IRC

CR: 42.5% (N=34)

PR: 17.5% (N=14)

SD: 13.75% (N=11)

PD: 16.25% (N=13)

NE: 10% (N=8)

ORR

ORR 60%

69

DoR, duration of response; NR, not reached; CR, complete response; PR, partial response; CI, confidence interval; mo, months

Data assessed by independent review committee (IRC)

Median DoR 21.7 months (95%CI: 21.7 – NR) Median DoR for CR patients: NR (95%CI: 21.7 – NR)

Median DoR for PR patients: 4.4 mo (95%CI: 2.0 – 9.1)


Duration of Response (DoR)

Patients have 43% probability of a CR

CR patients have >90% probability of a durable response at 22 months

70

CI, confidence interval; NR, not reached



Progression-free Survival (PFS)

Median Follow-up time 17.3 months

39 PFS events recorded

28 patients still ongoing with study treatment

71

CI, confidence interval; NR,not reached



Overall Survival (OS)

Median Follow-up Time: 19.6 months

29 deaths recorded


Summary

Durable responses and favorable overall

survival represent a very positive outcome

Tafasitamab + lenalidomide has the potential to be a

novel, chemo-free immunotherapy for r/r DLBCL patients

Tafasitamab + lenalidomide showed promising

activity with favorable safety profile

SUMMARY

73

Q&A Session


74

THANK YOU


MorphoSys AG Meet The Team · MorphoSys AG Meet The Team The Yale Club, New York June 25, 2019

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Transcript of MorphoSys AG Meet The Team · MorphoSys AG Meet The Team The Yale Club, New York June 25, 2019