Slide 1: MSD's Science-led Approach to Oncology Research & Development: ESMO 2025
MSD’s Science-led Approach to Oncology Research & Development: ESMO 2025 MSD Press Briefing 19 October 2025
Slide 2: Agenda
Agenda Kristen Drake • Opening | Kristen Drake Executive Director, Head of Oncology Communications • MSD’s oncology strategy and continued impact | Dr. Marjorie Green Dr. Marjorie Green SVP, Head of Oncology, • Exploring the future of the oncology pipeline | Dr. Jane Healy Global Clinical Developmen
Slide 3: Forward-looking statement of Merck & Co., Inc., Rahway, N.J., USA
Forward-looking statement of Merck & Co., Inc., Rahway, N.J., USA This presentation of Merck & Co., Inc., Rahway, 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 state
Slide 4: MSD's oncology strategy
MSD’s oncology strategy 4
Slide 5: MSD's broad portfolio of oncology products
MSD’s broad portfolio of oncology products* >3.6 million 60+ patients have been treated with ongoing Phase 3 studies2 commercially available medicines1 in oncology across 16 assets Subcutaneous pembrolizumab** Foundational cancer Subcutaneously administered TKI with multiple approved indications tre
Slide 6: Our strategy to maximize benefit to patients
Our strategy to maximize benefit to patients: unambiguous efficacy, informed combinations, biomarker enrichment, curative intent settings Combinable agents Biomarkers Earlier-stage disease Best outcomes occur Predictive biomarkers Early treatment when non-cross resistant enable stratification that i
Slide 7: Our oncology portfolio can be described in three biological pillars
Our oncology portfolio can be described in three biological pillars Immuno-oncology Precision molecular Tissue targeting targeting Boost anti-tumor Impact pathways that can Increase cancer cell immune responses drive cancer growth sensitivity with ADCs and immune-engagers 7
Slide 8: MSD's diverse portfolio and pipeline uniquely positioned to further cancer care
MSD’s diverse portfolio and pipeline, with mechanistic differentiators, is uniquely positioned to further cancer care Immuno-oncology Precision molecular targeting Tissue targeting Boost anti-tumor immune Impact pathways that can drive Increase cancer cell sensitivity responses cancer growth with AD
Slide 9: More than 10 novel candidates have advanced to late-phase development
More than 10 novel candidates have advanced to late-phase development Immuno-oncology Precision molecular targeting Tissue targeting Boost anti-tumor immune Impact pathways that can drive Increase cancer cell sensitivity responses cancer growth with ADCs and immune-engagers 2 3 sac-TMT5 HER3-DXd7 Su
Slide 10: MSD's continued impact in immuno-oncology
MSD’s continued impact in immuno-oncology 10
Slide 11: In earlier stage disease, KEYTRUDA is the only IO to demonstrate significant OS benefit in 5 studies
In earlier stage disease, KEYTRUDA is the only IO to date to demonstrate significant OS benefit in 5 studies, and to receive 10 U.S. FDA approvals / 7 EU approvals Lung Head & Neck Renal Skin Breast Cervical Bladder KN-689 KN-671 KN-564 KN-054 KN-522 KN-A18 Perioperative Perioperative resectable loc
Slide 12: Extensive ongoing, late-phase clinical development program for earlier stages of cancer
Extensive ongoing, late-phase clinical development program for earlier stages of cancer1 Esophageal Head & Neck KN-975 KN-689 Lung *KN-091 INTerpath-002 Breast *KN-671 INTerpath-009 *KN-522 KN-242 TroFuse-019 *OLYMPIA TroFuse-012 KN-756 TroFuse-032 More than Liver 30,000 patients2 LEAP-012 Skin in >
Slide 13: Perioperative EV plus pembrolizumab in MIBC: KEYNOTE-905
Perioperative enfortumab vedotin (EV) plus pembrolizumab in participants with muscle-invasive bladder cancer (MIBC) who are cisplatin-ineligible: Phase 3 KEYNOTE-905 study 100 90 77.8% EV + RC + PLND 80 74.7% pembrolizumab (control) Event-free survival, % 70 (N = 170) (N = 174) Key findings 60 Event
Slide 14: KEYNOTE-B96 progression-free survival in ovarian cancer
Pembrolizumab vs placebo plus weekly paclitaxel with or without bevacizumab for platinum-resistant recurrent ovarian cancer: Results from the randomized, double-blind Phase 3 ENGOT- ov65/KEYNOTE-B96 study: Progression-free survival in the CPS ≥1 and ITT populations at IA1 CPS ≥1 Patient Pts w/ Media
Slide 15: KEYNOTE-B96 overall survival in ovarian cancer
Pembrolizumab vs placebo plus weekly paclitaxel with or without bevacizumab for platinum-resistant recurrent ovarian cancer: Results from the randomized, double-blind Phase 3 ENGOT- ov65/KEYNOTE-B96 study: Secondary endpoint OS in the CPS ≥1 population at IA2 100 18-mo CPS ≥1 Patient Pts w/ Median,
Slide 16: Long-term outcomes from pembrolizumab monotherapy in NSCLC
Long-term outcomes from select clinical trials of pembrolizumab monotherapy for certain patients with locally advanced or metastatic non–small cell lung cancer a. The study designs of the 4 studies have been previously published. b. After protocol amendment, all participants received pembrolizumab 2
Slide 17: OS results from KEYNOTE-001, 010, 024 and 042
OS results from KEYNOTE-001, 010, 024 and 042* Pembrolizumab Chemotherapy Pembrolizumab Chemotherapy KEYNOTE-024a KEYNOTE-001a,b TPS ≥50% n/N = 36/154 n/N = 14/151 Any TPS n/N = 54/550 N/A 10y OS rate (95% CI) 11.3% (8.5%–14.5%) N/A 8y OS rate 24.3% (17.6%–31.5%) 12.8% (7.6%–19.3%) Median OS (95% CI
Slide 18: Exploring the future of the oncology pipeline
Exploring the future of the oncology pipeline 18
Slide 19: >30 ongoing late-phase oncology read-outs expected across pipeline candidates
>30 ongoing late-phase1 oncology read-outs expected across pipeline candidates with additional studies being planned zilovertamab raludotatug bomedemstat vedotin deruxtecan opevesostat (MK-3543) (MK-2140) (MK-5909)2 (MK-5684) MK-10845 LSD1 ROR1 CDH6 CYP11A1 KRAS G12C 2026 2027 2027 2028 2029 3 2 1 2
Slide 20: Advancing one of the industry's broadest ADC programs
Advancing one of the industry’s broadest ADC programs MK-2870 MK-2400 MK-5909 MK-1022 MK-2140 MK-3120 MK-2750 MK-6204 MK-6837 sacituzumab ifinatamab raludotatug patritumab Generic zilovertamab tirumotecan deruxtecan deruxtecan deruxtecan Undisclosed Undisclosed Undisclosed Undisclosed Name (sac-TMT)
Slide 21: R-DXd monotherapy in platinum-resistant ovarian cancer: REJOICE-Ovarian01
R-DXd monotherapy demonstrated promising antitumor activity in patients with platinum-resistant OC: Phase 2 (dose optimization) part of the Phase 2/3 REJOICE- Ovarian01 trial R-DXd 4.8 R-DXd 5.6 R-DXd 6.4 R-DXd 4.8– Confirmed response mg/kg mg/kg mg/kg 6.4 mg/kg by BICRa Key findings n=36 n=36 n=35
Slide 22: sac-TMT is a TROP2-directed ADC with a unique bifunctional linker
sac-TMT is a TROP2-directed ADC with a unique, bifunctional linker designed to reliably maximize payload delivery to the tumor cells Antibody Unique, bifunctional linker Cytotoxic payload anti-TROP2 membrane permeable irreversible connection pH-sensitive cleavage with the antibody to release the pay
Slide 23: sac-TMT vs chemotherapy in EGFR-mutated NSCLC: OptiTROP-Lung04
Sacituzumab tirumotecan (sac-TMT) vs platinum-based chemotherapy in EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC) following progression on EGFR-TKIs: Results from the randomized, multi-center Phase 3 OptiTROP-Lung04 study in China HR 0.49 (95% CI: 0.39 - 0.62) P < 0.0001 Sac-TMT Chemothera
Slide 24: Comprehensive development strategy for sac-TMT
Comprehensive development strategy for sac-TMT Combo/ Novel Biomarker Registrational Study Tumor Type Patient Population Approach Approach TroFuse-004 NSCLC 3L EGFRm NSCLC TroFuse-005 Endometrial Post platinum & post I/O endometrial cancer TroFuse-007 NSCLC PD-L1 TPS ≥ 50% TroFuse-009 NSCLC 2L non-s
Slide 25: Patient centricity in cancer care
Patient centricity in cancer care 25
Slide 26: Pembrolizumab has changed the treatment paradigm with 42 U.S. FDA-approved indications
Pembrolizumab has changed the treatment paradigm of numerous malignancies, with 42 U.S. FDA-approved indications in 18+ tumor types1 • Head and Neck Squamous Cell Cancer • Triple-Negative Breast Cancer KEYTRUDA®: • Non-Small Cell Lung Cancer • Melanoma Foundational Therapy • Malignant Pleural Mesoth
Slide 27: Phase 3 study of pembrolizumab SC vs IV with chemotherapy (MK-3475A-D77)
A Phase 3, randomized, open-label study of pembrolizumab SC* (pembrolizumab with berahyaluronidase alfa) vs pembrolizumab IV, in combination with platinum- doublet chemotherapya (MK-3475A-D77) 2 cyclesb Up to 16 cyclesb Key eligibility criteria Pembrolizumab SC 790 mg Q6Wc Pembrolizumab SC 790 mg Q6
Slide 28: Pembrolizumab SC noninferior to IV for exposure and trough concentration
Pembrolizumab SC* was shown to be noninferior to pembrolizumab IV with respect to cycle 1 overall exposure and steady state trough concentration Prespecified noninferiority margin for AUC0-6 wks (overall exposure) and Ctrough (steady state) geometric mean ratios: 0.8 Pembrolizumab SC Pembrolizumab I
Slide 29: Efficacy endpoints consistent between pembrolizumab SC and IV
Descriptive efficacy endpoints, such as ORR, PFS and OS were consistent between pembrolizumab SC* and pembrolizumab IV1 Pembrolizumab SC + chemotherapy vs 100 Pembrolizumab IV + chemotherapy: 90 80 • ORR (95% CI): 45.4% (39.1-51.8) vs 42.1% 70 (33.3-51.2); ORR ratio 1.08 (95% CI 0.85-1.37) 60 PFS, %
Slide 30: Phase 2 study of participant preference for pembrolizumab SC vs IV
A Phase 2 study of participant-reported preference for pembrolizumab SC* versus pembrolizumab IV Participant Preference Primary Endpoint: Participant preference for route of administration, pembrolizumab SC or pembrolizumab IV, as assessed by the Patient Preference Questionnaire® (PPQ) question 1 Cr
Slide 31: Q&A
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Slide 32: Marjorie Green, M.D.
Marjorie Green, M.D. Senior Vice President Head of Oncology Clinical Development Dr. Marjorie Green is senior vice president and head of late-stage oncology at MSD Research Laboratories. She leads all late-stage clinical development programs for oncology. Marjorie joined MSD from Seagen, where she w
Slide 33: Jane Healy, M.D.
Jane Healy, M.D. Vice President, Head of Early Oncology Development Dr. Jane Healy is vice president and head of early oncology development at MSD Research Laboratories. In this role, Dr. Healy is responsible for overseeing the early clinical development of numerous candidates in early-phase clinica
Slide 34: M. Catherine Pietanza, M.D.
M. Catherine Pietanza, M.D. Vice President, Head of Early Oncology Development Dr. M. Catherine (Cathy) Pietanza is vice president and therapeutic area head for gastrointestinal and genitourinary cancers, global clinical development at MSD Research Laboratories. In this role, Dr. Pietanza is respons