Merck & Company, Inc. · NYSE:MRK
Merck & — Investor Day (June 2021)
50 slides from Merck &'s investor day presentation, Jun 6, 2021
Slide 1: Merck Oncology Overview ASCO 2021
Merck Oncology Overview ASCO 2021
Slide 2: Agenda
Agenda • Overview of Oncology Program | Dr. Dean Li, President, Merck Research Labs • ASCO 2021 Highlights | Dr. Roy Baynes, SVP and Chief Medical Officer, MRL • Late-stage Pipeline | Dr. Vicki Goodman, VP of Late-stage Oncology Development, MRL • Early-stage Pipeline | Dr. Eric Rubin, SVP of Early-
Slide 3: Forward-looking statement of Merck & Co., Inc.
Forward-looking statement of Merck & Co., Inc., Kenilworth, N.J., USA 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. The
Slide 4: Dr. Dean Li
Dr. Dean Li President, Merck Research Labs
Slide 5: Uniquely positioned to drive long-term success and oncology leadership
Uniquely positioned to drive long-term success and oncology leadership through continued execution and momentum Broad oncology World-class scientific Extensive runway to Unmatched program with deep expertise and ability to advance science to commercial expertise pipeline of leverage KEYTRUDA’s reach
Slide 6: KEYTRUDA has demonstrated activity in more than 30 types of cancer
KEYTRUDA has now demonstrated activity in more than 30 different types of cancer defined by site of origin, histology, or genetic markers Melanoma1 NSCLC2 H&N3 Urothelial4 TNBC5 Gastric6 cHL7 NHL PMBCL8 Mesothelioma9 100 100 100 100 100 100 100 100 100 0 0 0 0 0 0 0 0 0 -100 -100 -100 -100 -100 -100
Slide 7: KEYTRUDA monotherapy and combinations improved outcomes in Phase 3 studies
KEYTRUDA monotherapy and in combination improved cancer outcomes in Phase 3 studies across a broad range of malignancies KEYNOTE-006 KEYNOTE-010 KEYNOTE-024 KEYNOTE-040 KEYNOTE-042 KEYNOTE-045 KEYNOTE-048 KEYNOTE-053 KEYNOTE-054 Pembro vs Ipi Pembro vs Docetaxel Pembro vs Chemo Pembro vs SOC Pembro
Slide 8: Broad oncology strategy to improve outcomes for cancer patients globally
Broad oncology strategy to improve outcomes for cancer patients globally Further establish Deepen responses Advance pipeline Identify patients KEYTRUDA as and extend benefit and pursue strategic most likely to foundational treatment with combinations collaborations benefit using and expand to additi
Slide 9: Industry's broadest immuno-oncology development program
Industry’s broadest immuno-oncology development program aimed to advance standard-of-care and address unmet needs >1,500 Ongoing clinical trials >120 Keytruda >1,000 trials in Combination adj/neoadjuv trials and earlier lines Merck’s Oncology Development >50 Program >100 Business Registrational deve
Slide 10: More than tripling the number of new indications and launches
More than tripling the number of new indications and launches across oncology portfolio over the next eight years >90 potential approvals PIPELINE ASSETS LENVIMA expected by 2028 LYNPARZA KEYTRUDA with more than 50 expected by 2025 2014-2020 2021-2028 10
Slide 11: Shaping the future of oncology with robust portfolio and pipeline
Shaping the future of oncology by leveraging our robust portfolio and pipeline… Further establish KEYTRUDA as a foundational anti-PD-1 cancer treatment in monotherapy and in combination regimens Ladiratuzumab Diversify through partnerships with PARPi, Vedotin (LV) VEGF TKI, HER2 TKI, LIV-1 ADC Diver
Slide 12: Dr. Roy Baynes
Dr. Roy Baynes SVP and chief medical officer, MRL 12
Slide 13: ASCO 2021: new, long-term and early data from broad portfolio
ASCO 2021: new, long-term and early data from broad portfolio New Data Including in Early- Stage Disease… … Demonstrating New Phase 3 data for KEYTRUDA in Patient Benefit ... Adjuvant RCC (KN-564) … And Progressing Novel Mechanisms New Lynparza data in adjuvant breast New outcomes data from KN-581 a
Slide 14: KEYNOTE-564: new data in adjuvant RCC
KEYNOTE-564: new data in adjuvant RCC demonstrated clinically meaningful improvement in disease-free survival compared to placebo Disease-free survival in ITT population KEYTRUDA following surgery HR 0.68 (95% CI, 0.53–0.87); P = 0.0010a reduced risk of recurrence or 100 90 death by 32% compared to
Slide 15: OlympiA: Lynparza in adjuvant breast cancer
OlympiA: Lynparza in adjuvant breast cancer changing survival expectations in certain early-stage patients 100 93.3 Lynparza reduced risk of invasive 89.2 88.4 85.9 disease recurrence or death by 42% 80 81.5 in gBRCAm High-risk HER2- early- Invasive Disease-Free 77.1 stage breast cancer based on Pha
Slide 16: Favezelimab (LAG-3): ASCO data in MSS CRC patients
Favezelimab (LAG-3): ASCO data shows anti-tumor activity in MSS CRC patients; advancing into Phase 3 study as co-formulation with KEYTRUDA Antitumor Response Favezelimab + Pembrolizumab N = 80 High unmet need in sick PD-L1 CPS ≥1 N = 36 PD-L1 CPS <1 N = 35 patients treated at later Best response n %
Slide 17: KEYNOTE-581: outcomes data in first-line RCC
KEYNOTE-581: outcomes data further supports benefit of combination for patients with first-line RCC KEYTRUDA plus LENVIMA significantly improved several health-related quality of life (HRQoL) measures compared with sunitinib in RCC patients • At ASCO GU 2021, data on the combination was highlighted
Slide 18: KEYNOTE-775: outcomes data in endometrial carcinoma
KEYNOTE-775: outcomes data further supports benefit of combination for patients with previously-treated endometrial carcinoma KEYTRUDA plus LENVIMA shows an overall favorable benefit/risk profile compared with physician’s choice treatment in endometrial carcinoma patients based on HRQoL data • At SG
Slide 19: KEYNOTE-811: new option for HER2+ gastric/GEJ cancer
KEYNOTE-811: KEYTRUDA+trastuzumab+chemotherapy becomes new treatment option for HER2+ metastatic gastric/GEJ cancer 100 100 80 Pembro Arm N = 124a 80 Placebo Arm N = 122a 60 Any decrease 97% 60 Any decrease 90% Change From Baseline (%) Change From Baseline (%) 40 Decrease of ≥80% 32% 40 Decrease of
Slide 20: Long-term follow-up data confirm durable benefits of KEYTRUDA
Long-term follow-up data confirm durable benefits of KEYTRUDA monotherapy or in combination across important indications Overall survival in ITT population Kaplan-Meier Estimates of DOR Overall survival in ITT population HR, 0.73 (95% CI, 0.60-0.88) P < 0.001 +XX% YOY 1L RCC 1L Bladder 2L Bladder In
Slide 21: Dr. Vicki Goodman
Dr. Vicki Goodman Vice President, Late-stage Oncology
Slide 22: Select assets from late-stage oncology program
Select assets from late-stage oncology program belzutifan vibostolimab quavonlimab favezelimab MK-1026 (HIF-2α) (TIGIT) (CTLA-4) (LAG-3) (BTK) 22
Slide 23: Belzutifan: efficacy in VHL-associated RCC and other tumor types
Belzutifan: continues to demonstrate efficacy in VHL- disease associated RCC and potential in other tumor types Updated data at ASCO showed durable responses and disease control in VHL-RCC MK-6482 Binds to HIF-2α and Prevents Its Heterodimerization with HIF-1β Normoxia (O2) Hypoxia HIF-2α HIF-2α Pro
Slide 24: Vibostolimab (TIGIT): advancing co-formulation development
Vibostolimab (TIGIT): advancing clinical development of co-formulation based on compelling early data MK-7684 + Pembrolizumab Arm • Presented vibostolimab combination data at ESMO 2020 in PD-1/L1-naïve patients; more to come • New Phase 3 study in PD-L1+ mNSCLC patients • New Phase 2 biomarker study
Slide 25: Quavonlimab (CTLA-4): co-formulation data in RCC
Quavonlimab (CTLA-4): encouraging co-formulation data in patients with RCC leads to late-stage development Cell Activation by Anti-CTLA-4 mAb • Evaluating as co-formulation with KEYTRUDA in 6 studies across 5 tumor types, including RCC, HCC, MSI-H CRC and Melanoma • Newly posted MSI-H CRC Phase 2 st
Slide 26: Favezelimab (LAG-3): co-formulation data lead to Phase 3
Favezelimab (LAG-3): early encouraging co-formulation data in MSS CRC patients leads to Phase 3 advancement MK-4280 Blocks the Interaction Between MHC Class II Receptors and LAG-3 • Encouraged by early data presented at SITC 2018 and most recently the data at ASCO 2021 • Advancing to Phase 3 in 2H 2
Slide 27: MK-1026 (BTK): plans for registrational studies
MK-1026 (BTK): plans to advance into studies with registrational intent based on strong early data and optimized dose • Encouraged by early data presented at ASH 2019 • Phase 2 under way to further understand and optimize dose and efficacy • Planning for registrational trials is under way • Demonstr
Slide 28: Dr. Eric Rubin
Dr. Eric Rubin SVP, Early-stage Oncology
Slide 29: Early oncology pipeline includes more than 25 investigational candidates
Early oncology pipeline* includes more than 25 investigational immuno-therapeutic candidates, including novel combinations with KEYTRUDA Pre-Clinical Phase 1 Phase 2 Molecules designed to stimulate Immune immune system functions, such as STING agonist (MK-2118) CD-27 agonist (MK-5890) Agonists enhan
Slide 30: Select assets from early-stage oncology program
Select assets from early-stage oncology program ILT-4 CD-27 LIV-1 ADC ROR-1 ADC antagonist agonist (MK-6440) (MK-2140) (MK-4830) (MK-5890) 30
Slide 31: MK-4830 (ILT-4 antagonist): initial efficacy data from Phase 1
MK-4830 (ILT-4 antagonist): first-time initial efficacy data from Phase 1 dose escalation study shows potential for asset in solid tumors ILT-4 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 prio
Slide 32: MK-2140 (ROR-1 ADC): activity in B-cell cancers
MK-2140 (ROR-1 ADC): promising activity in patients with previously-treated relapsed or refractory B-cell cancers 1 Change in Tumor Regression2 CRD (Cysteine-rich 3 Ig (Immunoglobulin domain) domain) ROR1 Kr (Kringle domain) Tumor cell TK (Kinase Ser/Thr Ser/Thr domain) PRD (Proline-rich domain) • D
Slide 33: MK-6440 (LIV-1 ADC): anti-tumor activity in TNBC
MK-6440 (LIV-1 ADC): anti-tumor activity demonstrated in TNBC and signal finding studies under way to evaluate in multiple other tumor types • Humanized IgG1 ADC selectively binds to cells expressing LIV-1 • LV-mediated delivery of MMAE drives anti-tumor activity Tumors LIV-1 RNA through cytotoxic c
Slide 34: MK-6440 (LIV-1): monotherapy and combination with KEYTRUDA in TNBC
MK-6440 (LIV-1): evaluating as monotherapy and in combination with KEYTRUDA for patients with TNBC Phase 1 Study of LV in solid tumors Phase 1/2 Trial in for 1L Treatment of Patients with Reduction in Total Tumor Burden by Best Unresectable Locally-Advanced or Metastatic TNBC: Overall Response – mTN
Slide 35: MK-5890 (CD-27 agonist): encouraging anti-tumor activity
MK-5890 (CD-27 agonist): encouraging anti-tumor activity MK-5890, anti-CD27 Best Percentage Change From Baselinein Target Lesions • Early anti-tumor activity observed in patients with advanced solid tumors in both the monotherapy and combination arms • Signal-finding effort in combination with KEYTR
Slide 36: Leader in precision medicine, identifying patients most likely to benefit
Leader in precision medicine, identifying patients most likely to benefit from treatment • First companion diagnostic for NSCLC: PD-L1 on tumor cells PD- L1 Expression • First companion diagnostic for gastric, cervical,bladder, esophagealand head & neck cancers: PD-L1 on tumor and immune cells • Fir
Slide 37: Leading biomarker-driven strategy
Leading biomarker-driven strategy In 2020, KEYTRUDA was granted two new biomarker-driven approvals: TMB-H cancers based on KN-158 results 1L MSI-H CRC based on PFS results from KN-177 demonstrating meaningful improvement in ORR The PD-L1 IHC22C3 Test was the first FDA-approved companion diagnostic i
Slide 38: Jannie Oosthuizen
Jannie Oosthuizen President, Global Oncology
Slide 39: Unmet needs are high and pace of innovation has accelerated
Unmet needs are high and pace of innovation has accelerated Unmet needs The science of Cost, health Strong need to Urgency to act remain and cancer oncology is system capability demonstrate value now to advance patients need accelerating, and affordability with data standard of care continued includ
Slide 40: Driving global leadership across broad portfolio of commercial assets
Driving global leadership across broad portfolio of commercial assets 40 Approved Indications 20 Tumor types Foundational cancer Market-leading Broad-based Highly-selective + MSI-H, treatment PARPi TKI small-molecule TKI TMB >730K 1 Patients treated with KEYTRUDA 40 1. Patients treated with commerci
Slide 41: Belzutifan: first-in-class molecule well positioned in RCC and beyond
Belzutifan: first-in-class molecule well positioned for success in RCC and beyond • First-in-class molecule targeting a gene Growth opportunities transcription factor, based on Nobel Prize- winning science in renal cell carcinoma and beyond • Result of successful business development and more … • Me
Slide 42: Lynparza: set for sustained class leadership in women's cancers
Lynparza: set for sustained class leadership in women’s cancers and beyond with earlier stage disease • Only PARPi approved in 7 indications across 4 different tumor types in the U.S. Growth opportunities across multiple tumor types • Moving into earlier lines of breast cancer treatment with OlympiA
Slide 43: Lenvima: establishing as TKI of choice with new indications
Lenvima: establishing as TKI of choice with roll-out of new indications • Combination program rolling out with new indications in 1L RCC and 2L Endometrial carcinoma – Growth opportunities approvals expected in 3Q21 across multiple tumor types • 20 combination studies ongoing across 14 tumor and mor
Slide 44: Well positioned for opportunity in early-stage treatment
Well positioned for opportunity in early-stage treatment across cancer types where prevalence is significant HEAD AND NECK BLADDER BREAST Early stage Metastatic Early stage Metastatic Metastatic Early stage Unknown Unknown Unknown MELANOMA RENAL LUNG Early stage Early stage Metastatic Early stage Me
Slide 45: KEYTRUDA broad adjuvant program with 20 registrational studies
KEYTRUDA is being explored in a broad adjuvant program with 20 registrational studies ongoing 2018 2019 2020 2021 2022 2023 2024 2025 2026+ Adjuvant TNBC NMIBC RCC Adjuvant Adjuvant Gastric & NSCLC Neo/adjuvant TNBC Adjuvant Melanoma Neoadjuvant / (KEYNOTE-057) (KEYNOTE-564) Melanoma Esophageal Neoa
Slide 46: Potential for 90+ approvals across oncology portfolio through 2028
Potential for 90+ approvals across oncology portfolio through 2028 Other (including co- Proportion of expected indications formulated assets) and new launches by product 46
Slide 47: Expect to be oncology market leader by 2026
Expect to be oncology market leader by 2026 driven by additional indications, earlier lines of therapy and new assets and technologies • Indications expected to more than triple over next 8 years o Earlier lines of therapy, including Merck adjuvant / neoadjuvant o New combinations and co-formulation
Slide 48: Dr. Dean Li
Dr. Dean Li President, Merck Research Labs
Slide 49: Uniquely positioned to drive long-term success and oncology leadership
Uniquely positioned to drive long-term success and oncology leadership through continued execution and momentum Broad oncology World-class scientific Extensive runway to Unmatched program with deep expertise and ability to advance science to commercial expertise pipeline of leverage KEYTRUDA’s reach
Slide 50: Q&A
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. 50