Merck & Company, Inc. · NYSE:MRK
Merck & — ESMO 2016 Investor Call
33 slides from Merck &'s conference presentation, Oct 9, 2016
Slide 1: Merck Oncology Overview
Merck Oncology Overview ESMO 2016 Investor Call October 9, 2016
Slide 2: Forward-Looking Statement of Merck & Co., Inc., Kenilworth, NJ, USA
Forward-Looking Statement of Merck & Co., Inc., Kenilworth, NJ, USA This presentation of Merck & Co., Inc., Kenilworth, NJ, USA (the “company”) includes “forward- looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 199
Slide 3: Topics we will cover
Topics we will cover 1 Merck Strategy in Oncology 2 Key Data presented at ESMO 2016 3 Executing Global Launch 4 Q&A 3
Slide 4: Merck's Oncology Strategy
Merck’s Oncology Strategy Extend and Improve the lives of people worldwide suffering from a wide range of cancers Establish KEYTRUDA as foundational treatment in monotherapy and in combination across multiple tumor types Explore combinations with standard of care and novel agents including other imm
Slide 5: Significant progress made in the last 5 years since KEYTRUDA entered the clinic
Significant progress made in the last 5 years since KEYTRUDA entered the clinic Progress since ASCO 2016 First anti-PD-1 to market in the U.S. Approvals in NSCLC (2L+ PD-L1+), Melanoma (1L+), H&N (2L+) Demonstrated overall survival as Monotherapy - vs. ipilimumab in melanoma - vs. docetaxel in
Slide 6: The Broadest Program of Any Anti-PD-1/PD-L1 Drug
The Broadest Program of Any Anti-PD-1/PD-L1 Drug More than 350 trials in more than 30 tumors; More than 100 Combination Trials EARLY DEVELOPMENT REGISTRATION Melanoma GITR (MK-4166) Head and Neck 1L (KN006) 1L + chemo/cetuximab (KN048) 2L (KN002) 2L (KN040) GITR (MK-1248) Adjuvant (KN053/054) 3L (KN
Slide 7: Several KEYTRUDA studies in multiple tumor types have been presented during ESMO
Several KEYTRUDA studies in multiple tumor types have been presented during ESMO Summary of major KEYTRUDA sessions only—in total, findings from 30 studies across 12 different cancer types have been presented at ESMO 2016 • Keynote-024: vs. Chemo as 1L NSCLC (TPS≥50%) - Oral • Keynote-021G: + Carbop
Slide 8: What we expect over the next 12 months
What we expect over the next 12 months • Many potential new filings across multiple tumor types • Anticipated approvals for NSCLC in multiple jurisdictions • Additional novel combination data • Additional internal I-O targets moving into the clinic 8
Slide 9: Topics we will cover
Topics we will cover 1 Merck Strategy in Oncology 2 Key Data presented at ESMO 2016 3 Executing Global Launch 4 Q&A 9
Slide 10: Keynote-024: vs. Chemo as 1L NSCLC (TPS≥50%)
Lung Keynote-024: vs. Chemo as 1L NSCLC (TPS≥50%) 10
Slide 11: Pembrolizumab versus Chemotherapy for PD-L1-Positive Non-Small-Cell Lung Cancer
Tke NEW ENGLAND JOURNAL ef MEDICINE ORIGINAL ARTICLE Pembrolizumab versus Chemotherapy for PD-L1-Positive Non—Small-Cell Lung Cancer Martin Reck, M.D., Ph.D. Delvys Rodriguez-Abreu, M.D., Andrew G. Robinson, M.D., Rina Hui, M.B., B.S., Ph.D., Tibor Cs6szi, M.D. Andrea Falop, M.D., Maya Gottfried, M.
Slide 12: KEYNOTE-024 Study Design and Key End-Points
KEYNOTE-024 Study Design and Key End-Points Study Design Key Eligibility criteria Pembrolizumab • Untreated stage IV NSCLC 200 mg IV Q3W (2 years) • PD-L1 TPS ≥50% • ECOG PS 0-1 R (1:1) • No activating EGFR mutation or N = 305 ALK translocation • No untreated brain metastases Platinum-Doublet Pembro
Slide 13: KEYNOTE-024 Baseline Characteristics
KEYNOTE-024 Baseline Characteristics Pembro Chemo N = 154 N = 151 Median age (range), y 64.5 (33-90) 66.0 (38-85) Men, n (%) 92 (60) 95 (63) Enrolled in east Asia 21 (14) 19 (13) ECOG PS 1, n (%) 99 (64) 98 (65) Squamous histology, n (%) 29 (19) 27 (18) Smoking status,a n (%) Current 34 (22) 31 (21)
Slide 14: KEYNOTE-024 Progression-Free Survival
KEYNOTE-024 Progression-Free Survival 50% risk reduction of disease progression No difference in PFS between PD-L1 50-75% vs. PD-L1 75-100% 14
Slide 15: KEYNOTE-024 Overall Survival and Objective Response
KEYNOTE-024 Overall Survival and Objective Response 40% risk reduction of death 50% crossover in ITT population 54% crossover excluding ongoing pts 15
Slide 16: KEYNOTE-024 Exposure and AE Summary
KEYNOTE-024 Exposure and AE Summary Pembrolizumab Chemotherapy N = 154 N = 150 7.0 mo 3.5 mo Exposure, median (range) (1 d-18.7 mo) (1 d-16.8 mo) Treatment-related AEs, n (%) 113 (73) 135 (90) Grade 3-4 40 (26) 77 (51) Serious 33 (21) 31 (21) Led to discontinuation 11 (7) 16 (11) Led to death 1 (<1)
Slide 17: Keynote-021G: + Carboplatin and Pemetrexed in 1L
Lung Keynote-021G: + Carboplatin and Pemetrexed in 1L 17
Slide 18: Carboplatin and pemetrexed with or without pembrolizumab for advanced NSCLC
Carboplatin and pemetrexed with or without pembrolizumab for advanced, non-squamous non-small-cell lung cancer: a randomised, phase 2 cohort of the open-label KEYNOTE-021 study Corey) Langer, ShirishM Gadgee, Hossein Borghaei, VassilikiA Papadimitrakopaulou, Amita Patnaik, Steven F Powdl, Ryan D Gen
Slide 19: KEYNOTE-021 Cohort G Study Design
KEYNOTE-021 Cohort G Study Design Pembrolizumab 200 mg Key Eligibility criteria Q3W for 2 years + • Untreated stage IIIB or IV Carboplatin AUC 5 nonsquamous NSCLC mg/mL/min + • No activating EGFR mutation or ALK Pemetrexed 500 mg/m2 translocation • Provision of a sample for R (1:1)a Q3W for 4 cycles
Slide 20: KEYNOTE-021 Cohort G Baseline Characteristics
KEYNOTE-021 Cohort G Baseline Characteristics Pembro + Chemo Chemo Alone N = 60 N = 63 Median age (range), y 62.5 (40-77) 66.0 (37-80) Women, n (%) 38 (63) 37 (59) ECOG PS 1, n (%) 35 (58) 34 (54) Adenocarcinoma histology, n (%) 58 (97) 55 (87) Stage IV disease, n (%) 59 (98) 60 (95) Smoking status,
Slide 21: KEYNOTE-021 Cohort G Overall Response and by PD-L1 TPS
KEYNOTE-021 Cohort G Overall Response and by PD-L1 TPS ORR nearly doubled with KEYTRUDA combo vs. chemo alone Significant ORR benefit with KEYTRUDA combo in PD-L1 negative and PD-L1 positive patients 21
Slide 22: KEYNOTE-021 Cohort G Progression Free Survival and Overall Survival
KEYNOTE-021 Cohort G Progression Free Survival and Overall Survival 47% risk reduction of disease progression Median PFS = 13.0 Months 51% crossover in ITT population 73% crossover excluding ongoing pts 22
Slide 23: KEYNOTE-021 Cohort G Exposure and AE Summary
KEYNOTE-021 Cohort G Exposure and AE Summary Pembro + Chemo Chemo Alone n = 59 n = 62 8.0 mo 4.9 mo Exposure, median (range) (1 d - 16.1 mo) (1 d - 15.3 mo) Treatment-related AEs, n (%) 55 (93) 56 (90) Grade 3-4 23 (39) 16 (26) Led to discontinuation 6 (10) 8 (13) Led to death 1 (2) 2 (3) 23 Data cu
Slide 24: Keynote-052: 1L bladder
GU Keynote-052: 1L bladder 24
Slide 25: KEYNOTE-052 Study Design
KEYNOTE-052 Study Design Patients (N = 350) Primary Endpoints Pembrolizumab • ORR in all patients • Advanced urothelial cancer • No prior chemotherapy for 200 mg Q3W • ORR in patients with metastatic disease PD-L1–positive tumors • ECOG PS 0-2 • Ineligible for cisplatin based on ≥ 1 of the First 100
Slide 26: KEYNOTE-052 Baseline Characteristics
KEYNOTE-052 Baseline Characteristics N = 100 N = 100 Characteristic n (%) Treatment n (%) Age, median (range), years 75 (44-94) Prior perioperative therapy 13 (13) ≥80 years, n (%) 34 (34) Prior BCG therapy 10 (10) Male, n (%) 76 (76) Reason for cisplatin ineligibility ECOG performance status, n (%)
Slide 27: KEYNOTE-052 Objective Response Rate
KEYNOTE-052 Objective Response Rate Confirmed Objective Response Rate Per RECIST v1.1, Central Review N = 100 n % (95% CI) Objective response rate (CR + PR) 24 24% (16-34) Complete response 6 6% (2-13) Partial response 18 18% (11-27) Stable disease 15 15% (9-24) Progressive disease 48 48% (38-58) No
Slide 28: Change in tumor size from baseline
Change in tumor size from baseline 28
Slide 29: Treatment Related Adverse Events
Treatment Related Adverse Events Treatment-Related AEs Any Grade Grade 3-4 Immune-Mediated AEs of Special Interest† n (%) N = 100 n (%) n (%) N = 100 Any 67 (67) 16 (16) Hypothyroidism Grade 2 6 (6) Fatigue 14 (14) 4 (4) Pneumonitis Pruritus 12 (12) 0 Grade 2 1 (1) Pyrexia 8 (8) 0 Grade 3 2 (2) Decr
Slide 30: Key takeaways from KEYNOTE studies presented at ESMO
Key takeaways from KEYNOTE studies presented at ESMO • KEYTRUDA is the only anti PD-1 to demonstrate superior efficacy in 1L NSCLC treatment in randomized controlled clinical trials • KEYTRUDA should become foundation of treatment for substantial portion of 1L metastatic NSCLC patients either as mon
Slide 31: Topics we will cover
Topics we will cover 1 Merck Strategy in Oncology 2 Key Data presented at ESMO 2016 3 Executing Global Launch 4 Q&A 31
Slide 32: We are launching KEYTRUDA globally across several tumor types… with more to come
We are launching KEYTRUDA globally across several tumor types… with more to come • Executing our strategy as a leader in oncology • Investing behind launches around the world – Melanoma in more than 50 markets – Lung in more than 30 markets – Head and Neck in the U.S. • Discussing value of biomarker
Slide 33: Q&A
Q&A