Oncology Overview
Transcript of Oncology Overview
MerckOncology Overview ESMO 2021
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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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).
Dr. Dean LiPresident, Merck Research Labs
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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Broad oncology strategy to improve outcomes for cancer patients globally
6
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
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
ESMO data demonstrates our leadership in early-stage disease, women’s cancers and beyond
8
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
Dr. Roy BaynesSVP and Chief Medical Officer, MRL
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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
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)
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
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
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
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
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
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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
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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Jannie OosthuizenPresident, Global Oncology
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
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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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
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
• 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
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
Q&A
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Appendix
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
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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
KEYTRUDA anti-tumor activity demonstrated in more than 25 cancer types
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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
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)
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