Merck & Company, Inc. · NYSE:MRK
Merck & — ESMO Investor Event 2021
31 slides from Merck &'s conference presentation, 2021
Slide 1: Merck Oncology Overview ESMO 2021
Merck Oncology Overview ESMO 2021
Slide 2: Agenda
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 2
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: 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 benefit foundational treatment with combinations collaborations from treatments and expand
Slide 7: Industry's broadest immuno-oncology development program
Industry’s broadest immuno-oncology development program aimed to advance standard-of-care and address unmet needs >1,600 >120 Ongoing clinical KEYTRUDA trials in trials Merck’s adj/neoadjuvant and earlier lines Oncology >1,100 Development >50 Combination trials Program Business development transacti
Slide 8: ESMO data demonstrates our leadership in early-stage disease, women's cancers and beyond
ESMO data demonstrates our leadership in early- stage disease, women’s cancers and beyond 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
Slide 9: Dr. Roy Baynes
Dr. Roy Baynes SVP and Chief Medical Officer, MRL 9
Slide 10: ESMO 2021: highlighting data in early-stage, women's cancers and across broad portfolio
ESMO 2021: highlighting data in early-stage, women’s cancers and across broad portfolio Exciting data in • KN-716 New data in stage II adjuvant melanoma • KN-522 Encore in adjuvant / neoadjuvant TNBC early-stage disease • KN-564 Patient reported outcomes in adjuvant RCC • KN-826 New data in 1L cervi
Slide 11: KEYNOTE-716: potential new treatment option in stage II melanoma
KEYNOTE-716: clinically meaningful data supports potential new treatment option in stage II melanoma Recurrence-Free Survival (Primary Endpoint) KEYTRUDA demonstrated a 35% reduction in the risk of disease recurrence or death compared to placebo • Represents a potential first treatment option in pat
Slide 12: KEYNOTE-826: first line cervical cancer combination regimen improving OS, PFS and ORR
KEYNOTE-826: first and only first line cervical cancer combination regimen improving overall survival (OS), progression free survival (PFS) and objective response rate (ORR) OS: All-Comer Population PFS: All-Comer Population Reduced the risk of death by 33% in the all- Improved PFS by 35% in the all
Slide 13: KEYNOTE-355: new standard of care in first line metastatic TNBC
KEYNOTE-355: results support new standard of care treatment regimen in first line metastatic TNBC Overall Survival: PD-L1 CPS ≥10 KEYTRUDA + chemotherapy resulted in statistically significant and clinically meaningful improvements in both OS and PFS versus chemotherapy alone • Reduced the risk of de
Slide 14: KEYNOTE-522: first phase 3 immunotherapy study with positive EFS
KEYNOTE-522: first phase 3 study with immunotherapy to demonstrate positive event free survival (EFS) results in high-risk early-stage TNBC EFS at Interim Analysis 4 KEYTRUDA + chemotherapy significantly prolonged EFS, reducing the risk of EFS events by 37% • Favorable trend for OS with final result
Slide 15: KEYNOTE-564: first positive phase 3 study of adjuvant immunotherapy in RCC
KEYNOTE-564: first positive phase 3 study of adjuvant immunotherapy in RCC Disease-free survival in ITT population Summary of FKSI-DRS scores 100 90 HR 0.68 (95% CI, 0.53–0.87); P = 0.0010a 80 70 60 12-mo rate DFS, % 50 85.7% 76.2% % Events Median (95% CI) 40 30 24-mo Pembro 22.0% NR (NR–NR) 20 rate
Slide 16: Expansive phase 3 prostate program and novel mechanisms
Building on our broad oncology portfolio with expansive phase 3 prostate program and novel mechanisms PROSTATE: KN-365 cohort A WELIREG: MK-6482-003 (encore) PSA% Change From Baseline Best Tumor Change From Baseline • 58.6% of patients experienced reduction in target lesion • 86.5% of patients exper
Slide 17: Potential foundational early-stage disease program across many tumor types
Potential foundational early-stage disease program across many tumor types HEAD & NECK ESOPHAGEAL KN-412 KN-975 KN-689 LUNG BREAST KN-091 KN-867 KN-522 KN-242 KN-671 KL-012 OLYMPIA KN-756 LIVER GASTRIC KN-937 KN-585 LEAP012 SKIN RENAL KN-054 KN-564 KN-716 KN-630 BLADDER WOMEN’S CANCERS KN-057 KN-905
Slide 18: Transforming cancer treatment with multiple agents and approaches across array of tumors
Transforming cancer treatment with multiple agents and approaches across array of tumors Prostate Cancer Renal Cell Carcinoma Breast Cancer Women’s Cancers Robust phase 3 Expansive set of Notable Broad profile across program 1 treatment options advancements with many tumors diverse assets KN-564: ad
Slide 19: Jannie Oosthuizen
Jannie Oosthuizen President, Global Oncology
Slide 20: Driving global leadership across a broad portfolio of commercial assets
Driving global leadership across a broad portfolio of commercial assets 45 Approved Indications 25 Foundational cancer Market-leading Broad-based treatment PARPi TKI Tumor Types + MSI-H, TMB Highly-selective First-in-class HIF-2α >1M 1 Patients treated small-molecule TKI Inhibitor with Merck Oncolog
Slide 21: Significant opportunities in early-stage treatment across cancer types
Significant opportunities in early-stage treatment across cancer types where prevalence is high HEAD AND NECK BLADDER BREAST Metastatic Early stage Early stage Early stage Metastatic Metastatic Unknown Unknown Unknown MELANOMA RENAL LUNG Early stage Early stage Early stage Metastatic Metastatic Meta
Slide 22: Transforming the treatment landscape across women's cancers
Transforming the treatment landscape across women’s cancers Breast Endometrial • 1st anti-PD-1 to demonstrate pCR and EFS • 1st cancer therapy approved for use based in early stage TNBC [KN-522] on a biomarker regardless of tumor type • First IO approved in early stage TNBC [KN-522] [KN-158] • Only
Slide 23: Expansive phase 3 prostate program
Building on our broad oncology portfolio with expansive phase 3 prostate program 95K 70K 37K 15K treatable treatable treatable treatable patients patients patients patients mHSPC 1L mCRPC 2L mCRPC 3L mCRPC KN-991 KN-641 KN-921 KL-10 PROPEL PROFOUND pembrolizumab olaparib study combination study Trea
Slide 24: WELIREG: first-in-class molecule with potential for success in RCC
WELIREG: first-in-class molecule with potential for success in RCC • First-in-class molecule targeting a gene transcription factor, based on Future growth opportunities Nobel Prize-winning science in renal cell carcinoma and more … • Result of successful business 1L in development along with clinica
Slide 25: Expect to be the oncology market leader driven by additional indications
Expect to be the oncology market leader driven by additional indications, earlier lines of therapy and new assets and technologies >90 potential approvals expected by 2028 …enables Merck to become the with more than 50 expected by 2025 … leading oncology company by 2025 Merck >3x increase Number of
Slide 26: 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. 26
Slide 27: Appendix
INVENTING FOR LIFE Appendix
Slide 28: 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 29: KEYTRUDA anti-tumor activity demonstrated across cancer types
KEYTRUDA anti-tumor activity demonstrated in more than 25 cancer types Melanoma1 100 NSCLC2 H&N3 Urothelial4 TNBC5 Gastric6 cHL7 100 100 100 100 100 100 0 0 0 0 0 0 0 -100 -100 -100 -100 -100 -100 -100 NHL PMBCL8 Mesothelioma9 Ovarian10 100 SCLC11 Esophageal12 NPC13 Anal14 100 100 100 100 100 100 Ch
Slide 30: Opportunity to shape the future by leveraging our robust portfolio and pipeline
We have an opportunity to shape the future by leveraging our robust portfolio and pipeline… Expanding the IO-IO strategy by CTLA-4 TIGIT LAG-3 ILT4 leveraging internal assets and (MK-1308/ (MK-7684/ (MK-4280/ (MK-4830) expanding combination possibilities quavonlimab) vibostolimab) favezelimab) with
Slide 31: Early-stage disease trials
Early-stage disease trials Trial Name: Tumor: Mono/Combo: PCD: KEYNOTE-091 NSCLC Mono/standard therapy 2021 - Interim KEYNOTE-412 Head & Neck Chemoradiation 2022 KEYNOTE-564 RCC Mono 2022 - OS KEYNOTE-676 Non-muscle invasive bladder BCG 2022 KEYLYNK-001 Ovarian BRCAwt Chemo followed by Lynparza 2023