Merck Oncology Overview€¦ · This presentation of Merck & Co., Inc., Kenilworth, N.J., USA (the...
Transcript of Merck Oncology Overview€¦ · This presentation of Merck & Co., Inc., Kenilworth, N.J., USA (the...
Merck Oncology Overview ESMO 2020
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).
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
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
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)
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
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
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
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.
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*
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
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
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%)
We have pursued collaborations, licensing agreements, and acquisitions that will increase our ability to provide benefit to cancer patients
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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
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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Appendix
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KEYTRUDA has now demonstrated activity in more than 30 different types of cancer defined by site of origin, histology, or genetic markers
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-100
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-100
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-100
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-100
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-100
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-100
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100NSCLC2
-100
0
100Gastric6
-100
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100
-100
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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
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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
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
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
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
20
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
21
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