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Merck Oncology Overview ESMO 2020

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Page 1: Merck Oncology Overview€¦ · This presentation of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the

Merck Oncology Overview ESMO 2020

Page 2: Merck Oncology Overview€¦ · This presentation of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the

Forward-looking statement

2

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 2019 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 3: Merck Oncology Overview€¦ · This presentation of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the

Extensive new data at ESMO further highlights how we are executing on a broad oncology strategy to improve outcomes for cancer patients globally

3

Further establishKEYTRUDA as foundational treatment and advance into earlier stages of disease

Broadly explorecombinations to reach more patients

Advance pipeline and pursue strategic collaborations and acquisitions to expand portfolio

Identify patients most likely to benefit using biomarkers

Page 4: Merck Oncology Overview€¦ · This presentation of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the

4

>1,300Ongoing

clinical trials

Registrational trials under way

>90

Combination trials>900

Trials in adjuvant / neoadjuvant

and earlier lines

>110

Comprehensive KEYTRUDA development program

Page 5: Merck Oncology Overview€¦ · This presentation of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the

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

5

Diversifying through partnerships with PARPi, VEGF TKI, HER2 TKI, ADCs

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

Pembro +

TIGIT

Pembro +

CTLA-4 HIF-2αBTKi

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

Pembro +

ILT4

*Seattle Genetics collaboration expected to close in third quarter.

Ladiratuzumab Vedotin (LV)

Page 6: Merck Oncology Overview€¦ · This presentation of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the

New Phase 3 data for KEYTRUDA in 1L Esophageal (KN-590)

New combination data with KEYTRUDA + LENVIMA in melanoma and other solid tumors (LEAP-004 and LEAP-005)

Final OS data in mCRPC (PROfound)

Long-term survival data for KEYTRUDA in NSCLC (KN-024), Adjuvant Melanoma (KN-054) and Head and Neck cancers (KN-048)

Long-term progression-free survival data for LYNPARZA ovarian cancer (SOLO-1)

New Phase 1 data from vibostolimab (TIGIT) program in NSCLC

First-time Phase 1 data from MK-4830 (ILT4) program in solid tumors

Additional data from MK-6482 (HIF-2α) in RCC and non-RCC malignancies

6

ESMO 2020: New, long-term and early data from broad portfolio

Presenting New Data …

… Demonstrating Long-Term Benefits ... … And Progressing Novel

Mechanisms

Page 7: Merck Oncology Overview€¦ · This presentation of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the

KEYNOTE-590: new KEYTRUDA data in 1L esophageal cancer in combination with chemotherapy demonstrated superior overall survival and progression-free survival compared to chemotherapy

7Data cutoff: July 2, 2020

KEYTRUDA plus chemotherapy reduced risk of death by 27% compared to chemotherapy as 1L treatment for patients with metastatic esophageal cancer, regardless of histology or PD-L1 expression status

First anti-PD-1 therapy in combination to show superior OS, PFS and ORR compared to chemotherapy, regardless of histology

Page 8: Merck Oncology Overview€¦ · This presentation of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the

LEAP-004: KEYTRUDA + LENVIMA in stage III melanoma introduces potential new treatment for PD-1/L1 refractory patients

8

LENVIMA in combination with KEYTRUDA showed antitumor activity in patients with advanced melanoma with confirmed progression on a PD-1/L1 inhibitor

• 21.4% BICR-confirmed ORR by RECIST v1.1 in total population

• 31.0% BICR-confirmed ORR in patients with PD on prior anti–PD-1/L1 + anti–CTLA-4

• 13.9-month median OS

Data cutoff: June 10, 2020

Page 9: Merck Oncology Overview€¦ · This presentation of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the

Long-term follow-up data confirm durable OS benefits of KEYTRUDA monotherapy in combination with chemo or as adjuvant following surgery

9

+XX% YOY

NSCLC Head and Neck Melanoma

The survival rate after five years from patients in KN-024 doubled vs. chemotherapy in the first-line treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS>50%). Additionally, duration of response was nearly five times longer than chemotherapy after five years (29.1 months vs. 6.3 months).

Long-term follow-up from KN-048 showed improved OS in KEYTRUDA vs. EXTREME arm and in KEYTRUDA+chemotherapy arm in the total, and CPS>20 and CPS>1 populations.

In a 3-yr follow-up on KEYNOTE-054, KEYTRUDA as adjuvant therapy, provided, a sustained improvement in RFS, which was clinically meaningful, in resected high-risk stage III melanoma.

Page 10: Merck Oncology Overview€¦ · This presentation of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the

Long-term follow-up data for LYNPARZA demonstrates OS benefit in BRCA1/2- or ATM-mutated mCRPC and PFS in BRCAm advanced ovarian cancer

10

Prostate Ovarian

In key secondary endpoint, following progression on enzalutamide or abiraterone, LYNPARZA reduced the risk of death by 31% vs. retreatment with enzalutamide or abiraterone for men with BRCA1/2 or ATM-mutated castration resistant prostate cancer (mCRPC).

LYNPARZA is the only PARP inhibitor to demonstrate OS in mCRPC.

Five-year follow-up data from the Phase 3 SOLO-1 trial showed LYNPARZA reduced the risk of disease progression or death by 67% and improved median PFS to 56 months vs. 13.8 months for placebo in BRCAm advanced ovarian cancer patients.

This data represents the longest follow-up analysis for any PARP inhibitor in 1L maintenance setting "following response to platinum-based chemotherapy.”

0 3230282624108642 34

90

80

70

60

50

40

30

20

10

0

100Ov

erall

surv

ival(

%)

12 14 16 18 20 22

Time since randomization (months)No. at risk

162 155 150 142 136 124 107 101 91 71 56 44 30 18 6 2 1 0

83 79 74 69 64 58 50 43 37 27 18 15 11 9 6 3 1 0Olaparib

Control

Olaparib (N=162)

Control (N=83)

Events, n (%) 91 (56) 57 (69)Median OS 19.1 months 14.7 months

HR (95% CI)0.69

(0.50‒0.97); P=0.0175*

Page 11: Merck Oncology Overview€¦ · This presentation of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the

Vibostolimab (TIGIT): first-time data from cohort expansion in patients with advanced NSCLC naïve to anti-PD-1/L1 therapy show compelling response rates

11

Vibostolimab is a monoclonal antibody that inhibits the T-Cell checkpoint inhibitor TIGIT

Vibostolimab in combination with KEYTRUDA showed compelling response rates in NSCLC patients naïve to anti-PD-1/L1 therapy

Combination showed 29% (12/41) ORR in all enrolled PD-1/L1 naïve patients and;• TPS>1% ORR 46% • TPS<1% ORR 25%

Moving to Phase 3 NSCLC in 2021

Additional exploratory studies across multiple other indications

Data cutoff: March 3, 2020

Page 12: Merck Oncology Overview€¦ · This presentation of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the

MK-4830 (ILT4): first-time initial efficacy data from Phase 1 dose escalation study shows potential for asset in solid tumors

12Data cutoff: July 10, 2020

ILT4 preliminary efficacy data showed an ORR of 24% (8/34) in patients who received MK-4830 in combination with KEYTRUDA

Among 11 patients who progressed on prior PD-1 therapy, there were 5 responses (45%)

Phase 2 umbrella studies in NSCLC under way

Page 13: Merck Oncology Overview€¦ · This presentation of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the

13

Promising clinical activity was observed with MK-6482 in treatment-naive patients with VHL-associated RCC• Confirmed ORR, 36.1 % (95% CI, 24.2-49.4);

7 other patients (11.5%) experienced unconfirmed PR • Median DOR, not yet reached; 91.8% of patients remain

on study therapy

Clinical activity was also observed in non-RCC lesions• In pancreatic lesions, confirmed ORR, 63.9%

(95% CI,50.6-75.8)• In CNS hemangioblastomas, confirmed ORR, 30.2%

(95% CI, 17.2-46.1)

In retinal lesions, 93.8% of patients had a best response of improved or stable

MK-6482 (HIF-2α): updated data on VHL-associated cRCC and non-RCC disease shows promising overall response rates

Benign Tumors

• CNS Hemangioblastoma (70-80%)• Retinal Hemangioblastoma (50-60%)• Pancreatic Cyst and Cystadenoma (50%)• Endolymphatic Sac Tumor

of the middle ear (10-25%)• Tumor of the Epididymis or Broad

Ligament (10-60%)

Areas of the Body Affected by von Hippel-Lindau Disease

Advanced/Malignant Tumors

• RCC (25-60%)• Pheochromocytoma (10-20%)• Pancreatic NET (10-20%)

Page 14: Merck Oncology Overview€¦ · This presentation of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the

We have pursued collaborations, licensing agreements, and acquisitions that will increase our ability to provide benefit to cancer patients

14

Development StageDevelopment Program

Kinase inhibitory discovery and development for treatment of patients with cancer and other diseases

Portfolio of investigational antibodies modulating TGFβ complex for the treatment of cancer, fibrosis and autoimmune disease

Development of novel small molecule therapeutic candidates targeting HIF-2α for the treatment of patients with cancer and other diseases

Collaboration for the development of small molecule inhibitors against several drug targets, including the KRAS oncogene

Gain access to an investigational intratumoral and intravenous formulationof the Coxsackievirus Type A21, designed to infect and kill cancer cells

Phase 2 in CLL

Preclinical

Phase 3 in sporadic RCCPhase 2 in VHL related RCC

Preclinical

Phase 2 in melanoma

Company

Strategic collaborations will enable us to further diversify Merck’s broad oncology portfolio and pipeline, and to continue our efforts to extend and improve the lives of as many patients with cancer as possible,

ladiratuzumab vedotin (LV) Phase 2 Tukysa – On market

*

*

* Indicates strategic collaboration

Page 15: Merck Oncology Overview€¦ · This presentation of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the

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.

15

Page 16: Merck Oncology Overview€¦ · This presentation of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the

Appendix

16

Page 17: Merck Oncology Overview€¦ · This presentation of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the

KEYTRUDA has now demonstrated activity in more than 30 different types of cancer defined by site of origin, histology, or genetic markers

17

-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 HCC16Esophageal12

-100

0

100Ovarian10

-100

0

100ER+/HER2– BC17 Cervical18

Thyroid19 Salivary20 Endometrial21

-100

0

100Melanoma1

-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

ccRCC27 nccRCC28

-100

0

100MSI-H non-CRC24

-100

0

100Merkel Cell26

-100

0

100

tTMB-H29

-100

0

100

cSCC30

-100

0

100

-100

0

100NHL PMBCL8

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.

= cancer types with approved indications

Page 18: Merck Oncology Overview€¦ · This presentation of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the

KEYTRUDA monotherapy and in combination improved overall survival in Phase 3 studies across a broad range of malignancies

N o . a t R is k

0 5 1 0 1 5 2 0 2 5 3 0 3 5 4 0 4 5 5 00

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 sO

S, %

2 5 7 1 9 7 1 5 2 1 1 0 7 02 5 5 2 0 7 1 3 1 8 9 4 0

9 15 9

00

4 32 1

2 19

1 35

10

2L+ NSCLC, TPS ≥50%

KEYNOTE-045Pembro vs Chemo

2L Bladder, Any PD-L1

KEYNOTE-024Pembro vs Chemo

1L NSCLC, TPS ≥50%

KEYNOTE-181Pembro vs Chemo

2L Esophageal, CPS ≥10

KEYNOTE-048Pembro vs EXTREME

1L HNSCC, CPS ≥1

0 1 0 2 0 3 0 4 0 5 0 6 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 9 0 1 7 8 1 3 1 1 0 1 11 5 2 5 8 2 9 2 1 1

5 01 0

00

0 6 12 18 24 30 36 42 480

10

20

30

40

50

60

70

80

90

100

Months

OS,

%

No. at Risk270 170 116 86272 140 73 47

6935

00

6028

5226

1712

0 6 12 18 24 30 36 42 480

10

20

30

40

50

60

70

80

90

100

Months

OS,

%

No. at Risk154 121 89 78 50151 108 61 48 24

7344

56

10680

6635

0 6 12 18 24 30 36 42 480

10

20

30

40

50

60

70

80

90

100

Months

OS,

%

No. at Risk637 463 368 304 91367 485 319 236 65

178126

00

12

3020

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

0 4 8 1 2 1 6 2 0 2 4 2 8 3 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 k2 7 8 2 3 7 1 9 0 1 1 01 3 5 1 1 3 8 4 4 2

1 5 26 5

00

5 72 3

1 68

11

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

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 sO

S, %

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

1L Gastric, CPS ≥10

KEYNOTE-006Pembro vs Ipi

Ipi-Naive Melanoma, Any PD-L1

0 10 20 30 40 50 600

10

20

30

40

50

60

70

80

90

100

Months

OS,

%

No. at Risk556 416 317 264278 158 111 94

4719

23385

20875

OS

OS

OS

OS

OS

OS

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

OS

OS

KEYNOTE-042Pembro vs Chemo

1L NSCLC, TPS ≥1%

KEYNOTE-010Pembro vs Docetaxel

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

OS

KEYNOTE-062Pembro vs Chemo

KEYNOTE-189Pembro + Pemetrexed/Platinum vs

Placebo + Pemetrexed/Platinum1L Nonsquamous NSCLC, Any PD-L1

0 3 6 9 1 2 1 5 1 8 2 1 2 4 2 7 3 0 3 3

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 k4 1 0 3 7 7 3 4 6 2 5 6 7 92 0 6 1 8 3 1 4 9 8 2 2 6

2 3 47 2

00

2 81 0

3 1 61 1 5

2 8 39 9

1 4 44 5

20

OS

0 6 12 18 24 300

10

20

30

40

50

60

70

80

90

100

MonthsO

S, %

No. at Risk228 175 60225 170 44

10289

158

10

KEYNOTE-604Pembro + EP vs

Placebo + EP 1L SCLC, Any PD-L1

OS

KEYNOTE-407Pembro + Carboplatin/Taxane vs

Placebo + Carboplatin/Taxane1L Squamous NSCLC, Any PD-L1

0 3 6 9 1 2 1 5 1 8 2 1

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 7 8 2 5 6 1 8 8 1 2 4 1 72 8 1 2 4 6 1 7 5 9 3 1 6

6 24 5

00

24

OS

KEYNOTE-426Pembro + Axitinib vs

Sunitinib1L RCC, Any PD-L1

0 4 8 1 2 1 6 2 0 2 4

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 k4 3 2 4 1 7 3 7 8 2 5 6 1 84 2 9 4 0 1 3 4 1 2 1 1 2 0

1 3 61 1 0

00

OS

KEYNOTE-048Pembro + Platinum

vs EXTREME1L HNSCC, Any PD-L1

0 5 1 0 1 5 2 0 2 5 3 0 3 5 4 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 8 1 2 2 7 1 6 9 1 2 2 4 02 7 8 2 2 7 1 4 7 1 0 0 2 0

7 55 1

00

1 05

11

OS

Monotherapy

Combinations

18

0 3 6 9 12 15 18 21 24 27 30 33 360

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

KEYNOTE-590Pembro + 5-FU/Cisplatin vs

Placebo + 5-Fu/Cisplatin 1L Esophageal, 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 Risk307 110352 104

6246

133150

10

228297

170197

1920

KEYNOTE-361Pembro vs Chemo

1L Bladder, Any PD-L1

KEYNOTE-522Pembro + Chemo/Pembro vs

Placebo + Chemo/PlaceboNeoadjuvant/Adjuvant TNBC, Any PD-L1

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

KEYNOTE-361Pembro + Gemcitabine/Platinum vs

Gemcitabine/Platinum 1L 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

OSOS EFS

RFS

KEYNOTE-054Pembro vs Placebo Adjuvant Melanoma

Page 19: Merck Oncology Overview€¦ · This presentation of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the

KEYTRUDA is being explored in a broad adjuvant program with 20 registrational studies ongoing

2018 2019 2020 2021 2022 2023 2024 2025 2026+

Adjuvant Melanoma (KEYNOTE-054) APPROVED

TNBC Neoadjuvant / Adjuvant(KEYNOTE-522)

pCR presented, File under review

cSCC Locally Advanced (KEYNOTE-629) APPROVED in recurrent or metastatic

HNSCC Adjuvant (KEYNOTE-412)

NSCLC Adjuvant (KEYNOTE-091)

Adjuvant Melanoma (KEYNOTE-716)

RCC Adjuvant (KEYNOTE-564)

Gastric & Esophageal Adjuvant / Neoadjuvant (KEYNOTE-585)

HNSCC Adjuvant / Neoadjuvant (KEYNOTE-689)

NSCLC Neoadjuvant (KEYNOTE-671)

Neo/adjuvant MIBC (KEYNOTE-866)

Neo/adjuvant MIBC (KEYNOTE-905)

NSCLC Stage I/IIa (KEYNOTE-867)

HCC Adjuvant (KEYNOTE-937)

Ovarian BRCAwt + chemo (KEYLYNK-001)

TNBC Adjuvant (KEYNOTE-242)

cSCC Locally Advanced (KEYNOTE-630)

ER+ / HER2-Breast Cancer Adjuvant / Neoadjuvant (KEYNOTE-756)

Timeline based on clinicaltrial.gov primary completion dates. Actual timing may vary.19

Page 20: Merck Oncology Overview€¦ · This presentation of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the

Extensive KEYTRUDA+LYNPARZA combination (KEYLYNK) and LYNPARZA monotherapy programs

• 1L, nonBRCA, KEYTRUDA combo (KEYLYNK-001)• 1L Maintenance BRCA+ (SOLO-1) - Approved

• 1L Maintenance, All Comers Combo + Bevacizumab (PAOLA-1) –Approved in HRD positive

• PSR, All Comers Combo + Cediranib (GY004)

• PRR, All Comers Combo + Cediranib (GY005)

• 2L+ PSR (SOLO2/Study19 ) - Approved

• 3L+ PSR, gBRCA Treatment (SOLO3)

• TNBC (KEYLYNK-009)• mBC, gBRCA (OlympiAD) - Approved

• HER2- Adjuvant, gBRCAm (OlympiA)

• 1L Maintenance gBRCA (POLO) - Approved

• mCRPC, All Comers (KEYLYNK-010)• mCRPC, HRRm (PROfound) - Approved

• mCRPC, All Comers Combo + Abiraterone (PROpel)

• 1L NSQ NSCLC (KEYLYNK-006)• 1L SQ NSCLC (KEYLYNK-008)• Stage III NSCLC (KEYLYNK-012)

• HRRm/HRD Basket (KEYLYNK-007)• HRRm Basket (LYNK-002)

LungCancer

TumorAgnostic

Ovarian cancer

Breastcancer

Pancreaticcancer

Prostatecancer

Lung cancer

Tumoragnostic

PRR: Platinum Relapsed Recurrent; PSR: Platinum Sensitive RecurrentCollaboration with AstraZeneca

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Extensive KEYTRUDA+LENVIMA combination (LEAP) and LENVIMA monotherapy programs

• 1L RCC Combo with Evero or KEYTRUDA (KN-581 / Study 307)

• 2L RCC Combo with Evero (Study 205) - Approved

• 1L EC (LEAP-001)• 2L EC (Study 309 / KN-775)• 2L EC (KEYNOTE-146) -

Approved

• 1L HCC Combo (LEAP-002)

• 1L HCC Combo/TACE (LEAP-012)• 1L HCC Mono (Study 304) – Approved

• 1L Melanoma (LEAP-003)• 2L Melanoma (LEAP-004)

• 1L UC (LEAP-011)

• 1L PD-L1+ HNSCC (LEAP- 010)

• TNBC

• Gastric

• Ovarian

• Colorectal

• Glioblastoma

• Biliary

• 1L NSQ Combo with KEYTRUDA and Chemo (LEAP-006)

• 1L PD-L1+ NSCLC (LEAP-007)• 2L NSQ (LEAP-008)

• 1L Thyroid -Approved

Endometrialcarcinoma

Hepatocellular carcinoma

Melanoma

Renal cell carcinoma

Thyroidcancer

Lungcancer

Urothelialcancer

Head & neck cancer

Basket trial

Registrational studies onlyCollaboration with Eisai

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22

Early oncology pipeline* includes more than 20 investigational immuno-therapeutic candidates – including novel combinations with KEYTRUDA

Personalized Cancer Vaccines

Tumor Microenvironment Modulators

Therapeutic vaccines based on patients’ specific cancer could

potentially prime the immune system to recognize certain characteristics

and attack the cancer cells

Regulating the environment around tumors, including

through oncolytic viruses, may influence tumor growth and its

interaction with the immune system

Phase 1 Phase 2

ImmuneAgonists

Molecules designed to stimulate immune system

functions, such as enhancing the activity of anti-tumor

immune cells

RIG-I receptor(MK-4621)

CD-27 agonist (MK-5890)

STING agonist (MK-1454)

Phase 1/2

Inhibition of Negative Immune Regulators

Blocking the action of molecules that suppress the

immune system may trigger a more robust anti-tumor

response

ILT4 antagonist (MK-4830)

LAG3 (MK-4280)

CTLA4 (MK-1308)

TIGIT (MK-7684)

RNA-based vaccine (Moderna)

(V940 / mRNA-4157)

CDK 1, 2, 5, 9(MK-7965)

V937 oncolytic virus (formerly CAVATAK)

BTK Inhibitor(MK-1026)

AKT Inhibitors(MK-7075 & MK-4440)

Pre-Clinical

TGFβ(Tilos Therapeutics)

KRAS (Moderna)(V941 / mRNA-5671)

KRAS – Taiho/Astex

*Select compounds only

ERK Inhibitor(MK-8353)

HIF-2α Inhibitor(MK-6482)

ILT3 antagonist