Oncology Overview

31
Merck Oncology Overview ESMO 2021

Transcript of Oncology Overview

Page 1: Oncology Overview

MerckOncology Overview ESMO 2021

Page 2: Oncology Overview

Agenda

• Introduction | Dr. Dean Li, President, Merck Research Labs (MRL)

• ESMO 2021 Highlights | Dr. Roy Baynes, SVP and Chief Medical Officer, MRL

• Commercial Opportunities | Jannie Oosthuizen, SVP of Oncology Human Health, Merck

• Q&A

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Page 3: Oncology Overview

Forward-looking statement of Merck & Co., Inc., Kenilworth, N.J., USA

3

This presentation of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2020 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Page 4: Oncology Overview

Dr. Dean LiPresident, Merck Research Labs

Page 5: Oncology Overview

Unmatched commercial expertise

to capitalize on significant

opportunities

Broad oncology program with deep

pipeline of differentiated early-

and late-stage assets

World-class scientific expertise and ability to leverage KEYTRUDA’s

foundational stature

Extensive runway to advance science to

reach more patients and solve for unmet

need

Uniquely positioned to drive long-term success and oncology leadership through continued execution and momentum

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Page 6: Oncology Overview

Broad oncology strategy to improve outcomes for cancer patients globally

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Further establishKEYTRUDA as foundational treatment and expand to additional tumor types and earlier stages of disease

Advance pipeline and pursue strategic collaborations and acquisitions to broaden portfolio

Identify patients most likely to benefit from treatments

Deepen responses and extend benefit with combinations

Page 7: Oncology Overview

Industry’s broadest immuno-oncology development program aimed to advance standard-of-care and address unmet needs

77

>1,600 Ongoing clinical

trials

>1,100 Combination trials

>100 Registrational trials

for KEYTRUDA under way

>20 Novel mechanisms

>120KEYTRUDA trials in adj/neoadjuvant and

earlier lines

>50 Business development

transactions in 2020

Merck’s Oncology

Development Program

Page 8: Oncology Overview

ESMO data demonstrates our leadership in early-stage disease, women’s cancers and beyond

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Continue to showcase expansion into earlier stages of disease

Highlight advances from our rapidly growing portfolio in women’s cancers

Demonstrate leadership in oncology by highlighting the breadth and depth of portfolio and pipeline

Page 9: Oncology Overview

Dr. Roy BaynesSVP and Chief Medical Officer, MRL

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Page 10: Oncology Overview

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ESMO 2021: highlighting data in early-stage, women’s cancers and across broad portfolio

Exciting data in early-stage disease

Commitment to women’s cancers

Progressing broad portfolio

• KN-716 New data in stage II adjuvant melanoma• KN-522 Encore in adjuvant / neoadjuvant TNBC• KN-564 Patient reported outcomes in adjuvant RCC

• KN-826 New data in 1L cervical cancer • KN-355 Final analysis in mTNBC• OReO Maintenance in ovarian cancer• KN-775 and KN-158 in endometrial cancers

• MK-6482 WELIREG in advanced RCC• KN-365 Cohort A in prostate cancer

Page 11: Oncology Overview

KEYNOTE-716: clinically meaningful data supports potential new treatment option in stage II melanoma

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KEYTRUDA demonstrated a 35% reduction in the risk of disease recurrence or death compared to placebo• Represents a potential first treatment option

in patients with resected, high-risk, stage II melanoma

• Builds on the foundation of efficacy and safety data already established by KEYNOTE-054 in stage III setting

Recurrence-Free Survival (Primary Endpoint)

Page 12: Oncology Overview

KEYNOTE-826: first and only first line cervical cancer combination regimen improving overall survival (OS), progression free survival (PFS) and objective response rate (ORR)

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KEYTRUDA + chemotherapy with or without bevacizumab demonstrated significant benefit in all populations including PD-L1 CPS ≥1 and CPS ≥10 with potential to be the new standard of care for women with persistent, recurrent, or metastatic cervical cancer

Reduced the risk of death by 33% in the all-comers population with a median OS of 24.4 mos for KEYTRUDA vs. 16.5 mos with chemo

Improved PFS by 35% in the all-comers population with a median PFS of 10.4 mos for KEYTRUDA vs. 8.2 mos with chemo

OS: All-Comer Population PFS: All-Comer Population

Page 13: Oncology Overview

KEYNOTE-355: results support new standard of care treatment regimen in first line metastatic TNBC

KEYTRUDA + chemotherapy resulted in statistically significant and clinically meaningful improvements in both OS and PFS versus chemotherapy alone

• Reduced the risk of death by 27% (HR=0.73)

• Increase of 6.9 months in median OS

• Addressing unmet medical need with the potential to extend lives of certain patients with this aggressive cancer

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Overall Survival: PD-L1 CPS ≥10

Page 14: Oncology Overview

KEYNOTE-522: first phase 3 study with immunotherapy to demonstrate positive event free survival (EFS) results in high-risk early-stage TNBC

KEYTRUDA + chemotherapy significantly prolonged EFS, reducing the risk of EFS events by 37%• Favorable trend for OS with final results pending

• Benefit consistent across all subgroups

• Results serve as the basis for the recent FDA approval of KEYTRUDA for patients with high-risk, early-stage TNBC

• KEYTRUDA + chemotherapy as part of a neoadjuvant/ adjuvant regimen has the potential to change the treatment paradigm

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EFS at Interim Analysis 4

Page 15: Oncology Overview

KEYNOTE-564: first positive phase 3 study of adjuvant immunotherapy in RCC

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KEYTRUDA following surgery reduced risk of recurrence or death by 32% compared to placebo for patients with RCC

0 5 10 15 20 25 30 35 40 450

10

20

30

40

50

60

70

80

90

100

Months

DFS

, %

No. at Risk

PembroPlacebo

496 457 414 371 1 0233 21151 61498 436 389 341 1 0209 19145 56

PembroPlacebo

HR 0.68 (95% CI, 0.53–0.87); P = 0.0010a

% Events Median (95% CI)

Pembro 22.0% NR (NR–NR)

Placebo 30.3% NR (NR–NR)

Median follow-up: 24.1 (14.9–41.5) mos.

aCrossed prespecified p-value boundary for statistical significance of 0.0114.ITT population included all randomized participants. NR, not reached. Data cutoff date: December 14, 2020.

Disease-free survival in ITT population

12-mo rate85.7%76.2%

24-mo rate77.3%68.1%

Updated ESMO data on KN-564 PRO shows no clinically meaningful differences in health-related QoL or symptom scores

• Favorable trend in OS with a 46% reduction in the risk of death with KEYTRUDA compared to placebo (HR=0.54 [95% CI, 0.30–0.96]; p=0.0164)

• Potential new standard of care in the adjuvant setting

Summary of FKSI-DRS scores

Page 16: Oncology Overview

Building on our broad oncology portfolio with expansive phase 3 prostate program and novel mechanisms

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Best Tumor Change From Baseline

WELIREG: MK-6482-003 (encore)PROSTATE: KN-365 cohort A

• 86.5% of patients experienced a reduction in target lesion size

• Median follow-up of 15.4 months, belzutifan + cabozantinib showed promising activity in all patients with previously treated aRCC

• ORR consistent across IMDC risk categories• Median PFS, 16.8 months

• 58.6% of patients experienced reduction in target lesion size among patients with RECIST-measurable disease

• Minimum of 11.4 months follow-up• Promising rPFS and OS data support further evaluation

of KEYTRUDA + olaparib

PSA% Change From Baseline

Page 17: Oncology Overview

17

LUNGKN-091KN-671

BREASTKN-242KN-756

WOMEN’S CANCERSKL-001 (OVARIAN)

KN-A18 (CERVICAL)KN-B21 (ENDOMETRIAL)

ESOPHAGEALKN-975

HEAD & NECKKN-412KN-689

BLADDERKN-057KN-676KN-866

GASTRICKN-585

RENALKN-564

LIVERKN-937 LEAP012

SKINKN-054KN-716KN-630

Potential foundational early-stage disease program across many tumor types

KN-522OLYMPIA

Approved Indication

KN-867KL-012

KN-905KN-992KN-B15

Page 18: Oncology Overview

Transforming cancer treatment with multiple agents and approaches across array of tumors

Breast Cancer Notable

advancements with diverse assets

Women’s Cancers Broad profile across

many tumors

Prostate Cancer Robust phase 3

program

Renal Cell CarcinomaExpansive set of

treatment options

KN-522: adj / neoadj TNBCKN-355: mTNBCTukysa: mHER2+ LIV-1: ADC in mTNBC

KN-365A: Ph IIKN-921: K+D mCRPCKN-641: K+E abi expKN-991: K+E mHSPCPROpel: 1L mCRPCPROfound: 1L-2L mCRPCKL-010: K+L 3L mCRPC

KN-564: adjuvantKN-426: K+axitinibKN-581: K+LenvimaLenvima: 2L+WELIREG: VHL associated RCCMonotherapy: sporadic RCC 2L-4LCombination therapies across lines of treatment

KN-826 / KN-A18: CervicalKN-775 / KN-158:EndometrialKL-001: OvarianLynparza Ovarian –multiple lines – OReO - rechallenge GARDASIL: HPV Vaccine

181 KN-921: KEYTRUDA+docetaxel; KN-641: KEYTRUDA+enzalutamide; KN-991: KEYTRUDA+enzalutamidePROpel: Lynparza+abiraterone; PROfound: Lynparza; KL-010: KEYTRUDA+Lynparza

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Page 19: Oncology Overview

Jannie OosthuizenPresident, Global Oncology

Page 20: Oncology Overview

Driving global leadership across a broad portfolio of commercial assets

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Lynparza, Lenvima and Tukysa are in partnership1 Tukysa is currently available in ex-US markets 2 Patients treated with commercially available product as of Sep 2021

>1MPatients treated

with Merck Oncology Products

45Approved

Indications

25Tumor

Types + MSI-H, TMB

Foundational cancertreatment

Market-leading PARPi

Highly-selective small-molecule TKI

First-in-class HIF-2αInhibitor

1

Broad-basedTKI

2

Page 21: Oncology Overview

Significant opportunities in early-stage treatment across cancer types where prevalence is high

Early stage

Metastatic

Unknown

HEAD AND NECK

Early stage

Metastatic

Unknown

BLADDER

Early stage

MetastaticUnknown

BREAST

Early stage Metastatic

Unknown

LUNG

Early stage

Metastatic

Unknown

RENAL

Early stage

Metastatic

Unknown

MELANOMA

Source: SEER 2020: Cancer Prevalence by Stage in U.S.

Meaningful opportunity to improve patient outcomes with earlier diagnosis and treatment

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Page 22: Oncology Overview

Transforming the treatment landscape across women’s cancers

• 1st anti-PD-1 to demonstrate pCR and EFS in early stage TNBC [KN-522]

• First IO approved in early stage TNBC [KN-522]• Only IO to demonstrate OS in mTNBC [KN-355]• 1st PARP to demonstrate survival in HER2-

adj breast cancer [OlympiA] • 1st PARP approved in HER2- mBC [OlympiAD]

• 1st cancer therapy approved for use based on a biomarker regardless of tumor type [KN-158]

• 1st IO+TKI to demonstrate survival in endometrial cancer [KN-775]

• 1st IO+TKI approved in endometrial cancer [KN-146]

• 1st IO approved in cervical cancer (2L) [KN-158]• 1st IO to demonstrate OS in 1L cervical cancer

[KN-826]• 1st vaccine to prevent HPV-related cervical

cancer

• 1st PARPi approved in ovarian cancer [SOLO-1]

Breast

Cervical

Endometrial

Ovarian

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Addressing high incidence and significant unmet medical need

Potential for

~15 launchesover the next 4 years

Page 23: Oncology Overview

Building on our broad oncology portfolio with expansive phase 3 prostate program

KN-991

1L mCRPC 2L mCRPC 3L mCRPCmHSPC

95Ktreatable patients

23Treatable patients sourced from Kantar

pembrolizumab combination study

olaparib study

70Ktreatable patients

37Ktreatable patients

15Ktreatable patients

KN-641 KN-921 KL-10

PROPEL

PROFOUND

Page 24: Oncology Overview

• First-in-class molecule targeting a gene transcription factor, based on Nobel Prize-winning science

• Result of successful business development along with clinical and commercial execution

• 3 pivotal clinical trials in progress assessing efficacy alone and in combination with TKI & IO in advanced renal cell carcinoma

WELIREG: first-in-class molecule with potential for success in RCC

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2-4LMonotherapy

2-3L inCombinationwith Lenvima

and more …

1L in Combinationwith Lenvima& Keytruda

APPROVED inVHL associatedRCC, CNS, pNET

Future growth opportunities in renal cell carcinoma

Page 25: Oncology Overview

2021E 2022E 2023E 2024E 2025E 2026E

Reve

nue

Source: Evaluate Pharma (as of 9/14/2021)

2014-2020 2021-2028PIPELINE ASSETS LENVIMA LYNPARZA KEYTRUDA

Expect to be the oncology market leader driven by additional indications, earlier lines of therapy and new assets and technologies

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>90 potential approvals expected by 2028with more than 50 expected by 2025 …

…enables Merck to become the leading oncology company by 2025

Merck

Num

ber o

f ind

icat

ions

>3xincrease

Page 26: Oncology Overview

Q&A

To ask a question on the operator-assisted audio line, press *1.

Note: be sure to mute your computer speakers if you are listening to the audio webcast.

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Page 27: Oncology Overview

Appendix

Page 28: Oncology Overview

KEYTRUDA monotherapy and in combination improved cancer outcomes in phase 3 studies across a broad range of malignancies

0 10 20 30 40 50 600

10

20

30

40

50

60

70

80

90

100

Months

PFS,

%

No. at Risk153 73 53154 56 14

6025

288

62

00

0 8 16 24 32 40 48 56 64 720

10

20

30

40

50

60

70

80

90

100

Months

OS,

%

No. at Risk270 148 49272 109 25

9859

4224

3623

6935

00

5827

116

0 10 20 30 40 50 600

20

40

60

80

100

Months648 509 440 410 344 86 0655 396 336 290 227 61 1

No. at Risk

0 5 10 15 20 25 30 35 40 450

10

20

30

40

50

60

70

80

90

100

Months

DFS

, %

No. at Risk496 151498 145

6156

233209

00

457436

414389

11

371341

2119

0 8 16 24 32 40 480

10

20

30

40

50

60

70

80

90

100

Months

OS,

%

No. at Risk278 190 79135 84 27

12249

00

5316

162

0 6 12 18 24 30 36 42 48 54 60 660

10

20

30

40

50

60

70

80

90

100

Months

OS,

%

No. at Risk637 463 304 246 100637 485 236 177 60

193131

00

10

5940

368319

156100

1912

0 12 24 36 48 60 720

10

20

30

40

50

60

70

80

90

100

Months

OS,

%

No. at Risk690 333 217 148 90343 114 46 35 18

11027

113

Monotherapy

0 12 24 36 48 60 720

10

20

30

40

50

60

70

80

90

100

Months

OS,

%

No. at Risk556 387 297 245278 145 103 90

00

21179

17769

KEYNOTE-006Pembro vs Ipi

Ipi-Naive Melanoma, Any PD-L1

OS

0 6 12 18 24 30 36 42 48 54 60 66 720

10

20

30

40

50

60

70

80

90

100

Months

OS,

%

No. at Risk154 121 78 66 20151 108 48 35 13

6233

00

8961

5126

10680

7344

5428

03

KEYNOTE-024Pembro vs Chemo

1L NSCLC, TPS ≥50%

OS

0 5 1 0 1 5 2 0 2 5 3 0

0

1 0

2 0

3 0

4 0

5 0

6 0

7 0

8 0

9 0

1 0 0

M o n t h s

OS

, %

N o . a t R is k2 4 7 1 6 0 1 0 32 4 8 1 5 1 8 2

4 83 4

00

1 41 0

21

KEYNOTE-040Pembro vs SOC

2L+ HNSCC, Any PD-L1

OS

KEYNOTE-042Pembro vs Chemo

1L NSCLC, TPS ≥1%

OS

0 5 10 15 20 25 30 35 40 45 50 55 600

10

20

30

40

50

60

70

80

90

100

Months

OS,

%

No. at Risk257 197 152 92 62255 207 132 60 29

7142

00

5522

2210

126

20

11190

4016

KEYNOTE-048Pembro vs EXTREME1L HNSCC, CPS ≥1

OS

KEYNOTE-181Pembro vs Chemo

2L Esophageal, CPS ≥10

0 4 8 12 16 20 24 28 32 360

10

20

30

40

50

60

70

80

90

100

Months

OS,

%

No. at Risk107 86 59 45 10115 76 48 23 9

2914

00

54

01

2114

OS

KEYNOTE-240Pembro vs Placebo2L HCC, Any PD-L1

OS

0 5 10 15 20 25 30 35 400

10

20

30

40

50

60

70

80

90

100

Months

OS,

%

No. at Risk96 79 57 41 2398 80 54 36 12

00

114

11

2623

KEYNOTE-119Pembro vs Chemo

2/3L TNBC, CPS ≥10

OS

0 6 1 2 1 8 2 4 3 0 3 6 4 20

1 0

2 0

3 0

4 0

5 0

6 0

7 0

8 0

9 0

1 0 0

M o n t h s

OS

, %

N o . a t R is k9 2 6 2 5 29 0 7 0 4 2

4 52 8

00

3 21 6

1 37

40

KEYNOTE-062Pembro vs Chemo 1L Gastric, CPS ≥10

OS

KEYNOTE-045Pembro vs Chemo

2L Bladder, Any PD-L1

OS

KEYNOTE-010Pembro vs Docetaxel 2L+ NSCLC, TPS ≥1%

OS

0 6 12 18 24 30 36 420

10

20

30

40

50

60

70

80

90

100

Months

OS,

%

No. at Risk307 110352 104

6246

133150

10

228297

170197

1920

KEYNOTE-361Pembro vs Chemo

1L Bladder, Any PD-L1

OS

RFS

KEYNOTE-054Pembro vs Placebo

Adj MEL, High-Risk Stg III

PFS

KEYNOTE-177Pembro vs Chemo

1L MSI-H/dMMR CRC, Any PD-L1

0 6 12 18 24 30 36 42 480

10

20

30

40

50

60

70

80

90

100

Months

PFS,

%

No. at Risk270 170 116 86272 140 73 47

6935

00

6028

5226

1712

KEYNOTE-204Pembro vs BV

R/R cHL, Any PD-L1

PFS

KEYNOTE-053Pembro vs IFN or Ipi

Adj MEL, High-Risk Stg III

RFS

RFS

KEYNOTE-564Pembro vs Placebo

Adjuvant RCC

KEYNOTE-716Pembro vs Placebo

Adj MEL, High-Risk Stg II

0 3 6 9 12 15 18 21 24 270

10

20

30

40

50

60

70

80

90

100

Months

RFS

, %

No. at Risk487 465 401 340 149489 475 400 336 149

00

7171

2127

249229

11

RFS

0 6 12 18 24 30 36 42 48 540

10

20

30

40

50

60

70

80

90

100

Months

OS,

%

No. at Risk220 154 105103 66 35

12746

7322

176

00

19391

8425

4312

0 6 12 18 24 30 36 42 48 540

10

20

30

40

50

60

70

80

90

100

Months

OS,

%

No. at Risk432 407 286429 379 252

384336

259224

1612

318279

00

345306

141110

0 3 6 9 12 15 18 21 24 270

10

20

30

40

50

60

70

80

90

100

Months

EFS,

%

No. at Risk784 780 765 666 519390 386 380 337 264

00

376186

242116

7335

21

Combinations

0 6 12 18 24 30 36 42 48 540

10

20

30

40

50

60

70

80

90

100

Months

OS,

%

No. at Risk410 347 234 184 99206 149 72 55 29

12534

00

28398

14942

2810

KEYNOTE-048Pembro + Chemo vs

EXTREME1L HNSCC, Any PD-L1

0 5 10 15 20 25 30 35 40 45 50 55 600

10

20

30

40

50

60

70

80

90

100

Months

OS,

%

No. at Risk281 227 169 94 70278 227 148 67 32

7847

00

6324

308

92

10

122101

4917

OS

KEYNOTE-361Pembro + Chemo vs

Chemo1L Bladder, Any PD-L1

0 6 12 18 24 30 36 420

10

20

30

40

50

60

70

80

90

100

Months

OS,

%

No. at Risk351 118352 104

5646

168150

00

306297

217197

1720

OSKEYNOTE-189

Pembro + Chemo vs Placebo + Chemo

1L Nonsquam NSCLC, Any PD-L1

OS

KEYNOTE-426Pembro + Axitinib vs

Sunitinib1L RCC, Any PD-L1

KEYNOTE-407Pembro + Chemo vs

Placebo + Chemo1L Squam NSCLC, Any PD-L1

0 6 12 18 24 300

10

20

30

40

50

60

70

80

90

100

MonthsO

S, %

No. at Risk278 232 180 119 46281 246 137 91 36

43

OS OS0 3 6 9 12 15 18 21 24 27 30 33 36

0

10

20

30

40

50

60

70

80

90

100

Months

OS,

%

No. at Risk373 348 68376 338 51

235200

1715

74

151108

00

295274

187147

11882

3628

21

OS

KEYNOTE-590Pembro + Chemo vs

Placebo + Chemo1L Esophageal, Any PD-L1

KEYNOTE-604Pembro + EP vs

Placebo + EP 1L SCLC, Any PD-L1

0 6 12 18 24 300

10

20

30

40

50

60

70

80

90

100

Months

OS,

%

No. at Risk228 175 60225 170 44

10289

158

10

OS

KEYNOTE-522Pembro + Chemo/Pembro vs

Placebo + Chemo/PlaceboNeoadj/Adj TNBC, Any PD-L1

EFS

KEYNOTE-355Pembro + Chemo vs

Placebo + Chemo1L TNBC, CPS ≥10

OS

KEYNOTE-775 (Study 309)Pembro + Lenvatinib vs Doxorubicin or Paclitaxel

2L EC, Any PD-L1

OSKEYNOTE-581 (CLEAR)Pembro + Lenvatinib vs

Sunitinib1L RCC, Any PD-L1

OS

KEYNOTE-826Pembro + Chemo ± Bev vs

Placebo + Chemo ± Bev1L Cervical, Any PD-L1

0 3 6 9 12 15 18 21 24 27 300

10

20

30

40

50

60

70

80

90

100

Months

OS,

%

No. at Risk308 291 277 254 201309 295 268 234 160

00

145116

8960

3628

228191

64

OS

Page 29: Oncology Overview

KEYTRUDA anti-tumor activity demonstrated in more than 25 cancer types

29

1. Daud A et al. ASCO 2015; 2. Garon EB et al. ESMO 2014; 3. Seiwert T et al. ASCO 2015; 4. Plimack E et al. ASCO 2015; 5. Nanda R et al. SABCS 2014; 6. Bang YJ et al. ASCO 2015; 7. Moskowitz C et al. ASH 2014; 8. Zinzani PL et al. ASH 2015; 9. Alley EA et al. AACR 2015; 10. Varga A et al. ASCO 2015; 11. Ott PA et al. 2015 ASCO; 12. Doi T et al. ASCO 2015; 13. Hsu C et al. ECC 2015; 14. Marabelle A et al. ASCO 2020; 15. Bang Y-J et al. ECC 2015; 16. Zhu A et al. ASCO 2018; 17. Rugo HS et al. SABCS 2015; 18. Frenel JS et al. ASCO 2016; 19. Mehnert JM et al. ASCO 2016; 20. Cohen R et al. ASCO 2016; 21. Ott PA et al. ASCO 2016; 22. Hansen AR et al. ESMO 2016; 23. Reardon D et al. SNO 2016; 24. Diaz L et al. ESMO 2017; 25. Mehnert J et al. ESMO 2017; 26. Nghiem P et al. ASCO 2018; 27. McDermott DF et al. ASCO 2018; 28. McDermott DF et al. ASCO-GU 2019; 29. Marabelle A et al. ESMO 2019; 30. Grob JJ et al. ESMO 2019.

-100

0

100

-100

0

100

-100

0

100

-100

0

100

-100

0

100

-100

0

100

-100

0

100NSCLC2

-100

0

100Gastric6

-100

0

100

-100

0

100H&N3 TNBC5

-100

0

100cHL7Urothelial4

Chan

ge F

rom

Bas

elin

e in

Tum

or S

ize,

%

-100

0

100Mesothelioma9

-100

0

100Anal14

-100

0

100

-100

0

100SCLC11

-100

0

100NPC13

HCC16

Esophageal12

-100

0

100Ovarian10

-100

0

100ER+/HER2– BC17 Cervical18 Thyroid19 Salivary20 Endometrial21

-100

0

100Melanoma1

-100

0

100NHL PMBCL8

-100

0

100Biliary Tract15

-100

0

100Prostate22 GBM23

-100

0

100

-100

0

100MSI-H CRC24

-100

0

100

-100

0

100Carcinoid25

-100

0

100pNET25

-100

0

100ccRCC27 nccRCC28

-100

0

100MSI-H non-CRC24

-100

0

100Merkel Cell26

-100

0

100tTMB-H29

-100

0

100cSCC30

Page 30: Oncology Overview

We have an opportunity to shape the future by leveraging our robust portfolio and pipeline…

30

Diversifying through partnerships with PARPi, VEGF TKI, HER2 TKI, LIV1 ADC

Further establishing KEYTRUDA® as a foundational anti-PD-1 cancer treatment in monotherapy and in combination regimens

BTK (MK-1026)

Expanding the IO-IO strategy by leveraging internal assets and expanding combination possibilities with targeted small molecules

Ladiratuzumab Vedotin (LV)

ROR-1 ADC(MK-2140/ zilovertamab

vedotin )

TIGIT (MK-7684/

vibostolimab)

CTLA-4(MK-1308/

quavonlimab)

ILT4(MK-4830)

LAG-3(MK-4280/

favezelimab)

Diversifying through acquisitions with BTK, HIF-2α, ROR-1 ADC HIF-2α

(MK-6482)

Page 31: Oncology Overview

Early-stage disease trials

31

Trial Name: Tumor: Mono/Combo: PCD:KEYNOTE-091 NSCLC Mono/standard therapy 2021 - InterimKEYNOTE-412 Head & Neck Chemoradiation 2022KEYNOTE-564 RCC Mono 2022 - OSKEYNOTE-676 Non-muscle invasive bladder BCG 2022KEYLYNK-001 Ovarian BRCAwt Chemo followed by Lynparza 2023KEYNOTE-585 Gastric Chemo 2024KEYNOTE-671 NSCLC Chemo 2024KEYNOTE-A18 Cervical Chemoradiation 2024KEYNOTE-937 HCC Mono 2025KEYNOTE-866 Muscle-invasive bladder Chemo 2025KEYNOTE-867 NSCLC Stage I/IIA Stereostatic body radiotherapy 2025KEYNOTE-689 Head & Neck Mono/Chemoradiation 2025KEYNOTE-630 Cutaneous squamous cell Mono 2025KEYNOTE-B21 Endometrial Chemo +/- KEYTRUDA 2025LEAP-012 HCC Combo/ Chemoradiation 2025KEYNOTE-905 Bladder Cystectomy/EV 2026KEYNOTE-242 TNBC Mono 2026KEYNOTE-992 Muscle-invasive bladder Chemoradiation 2026KEYNOTE-975 Esophageal Chemoradiation 2026KEYNOTE-B15 Muscle-invasive bladder Enfortumab Vedotin (EV) 2026KEYLINK-012 NSCLC Combo/ Chemoradiation 2026KEYNOTE-756 ER+/HER2- Breast Chemo 2031

Includes trials that have not yet read out