Slide 1: Merck Oncology Overview ASCO 2018
MERCK ONCOLOGY OVERVIEW ASCO 2018 JUNE 4, 2018
Slide 2: Forward-Looking Statement of Merck & Co., Inc.
Forward-Looking Statement of Merck & Co., Inc., Kenilworth, NJ, 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. These
Slide 3: Merck Oncology
MERCK ONCOLOGY Establish KEYTRUDA as A LEADER IN foundational treatment in monotherapy and in DELIVERING combination across multiple tumor Identify BREAKTHROUGH types and stages of disease APPROACHES THAT EXTEND AND Explore combinations and Identify patients most likely to IMPROVE THE other novel ag
Slide 4: ASCO: Breadth of Data
ASCO: BREADTH OF DATA 25+ TUMOR TYPES FROM EXPANSIVE CLINICAL PROGRAM 140 ABSTRACTS ACCEPTED FROM LUNG CERVICAL OUR BROAD ONCOLOGY RENAL CELL MERKEL CELL PORTFOLIO PROSTATE ENDOMETRIAL HEAD AND NECK ESOPHAGEAL MELANOMA OVARIAN 4
Slide 5: ASCO 2018 Spotlight on NSCLC
KEYNOTE-054: Pembrolizumab versus placebo after complete resection of high- ASCO 2018 Melanoma risk stage III melanoma KEYNOTE-407 KEYNOTE-042 KEYNOTE-021G SPOTLIGHT ON Randomized, open-label Phase 3 NSCLC Randomized, double-blind, placebo study in patients with locally Multicenter, open-label, Phas
Slide 6: KEYNOTE-407
KEYNOTE-407 KEYTRUDA DEMONSTRATES SIGNIFICANT IMPROVEMENT IN OS REDUCED RISK Events HR (95% CI) P OF DEATH BY Pembro + Chemo Placebo + Chemo 30.6% 42.7% 0.64 (0.49-0.85) 0.0008 36% COMPARED 82.6% TO CHEMO HR = .64 100 76.1% ALONE [95% CI, 0.49-0.85] 90 80 70 60 Median (95% CI) OS, % 50 15.9 mo (13.2
Slide 7: KEYNOTE-407: OS Benefit Across All PD-L1 Subgroups
KEYNOTE-407 OS BENEFIT ACROSS ALL PD-L1 SUBGROUPS FIFTH KEYTRUDA TPS <1% TPS 1-49% TPS ≥50% PHASE 3 TRIAL TO Pembro + Chemo Events 30.5% HR (95% CI) 0.61 (0.38-0.98) Events 30.1% HR (95% CI) 0.57 (0.36-0.90) Events 31.5% HR (95% CI) 0.64 (0.37-1.10) DEMONSTRATE Placebo + Chemo 44.4% 43.3% 41.1% IMPR
Slide 8: KEYNOTE-189 (AACR 2018)
KEYNOTE-189 (AACR 2018) OS BENEFIT ACROSS ALL PD-L1 SUBGROUPS OVERALL SURVIVAL IS THE GOLD STANDARD TPS <1% TPS 1-49% TPS ≥50% SETS THE BAR HR HR HR Events (95% CI) Pa Events (95% CI) Pa Events (95% CI) Pa Pembro/Pem/Plat 38.6% 0.59 0.0095 28.9% 0.55 0.0081 25.8% 0.42 0.0001 Placebo/Pem/Plat 100 55.
Slide 9: KEYNOTE-042
KEYNOTE-042 PHASE 3 TRIAL STUDYING KEYTRUDA IN SIGNIFICANT METASTATIC NONSQ AND SQ NSCLC AT TPS > 1% IMPROVEMENT IN Pembrolizumab Events 371 HR (95% CI) 0.81 P 0.0018 OVERALL Chemotherapy 438 (0.71-0.93) SURVIVAL IN 39.3% PATIENTS WITH PD-L1 >1% 28.0% HR=0.81 [95% CI, 0.71-0.93] Median (95% CI) 16.7
Slide 10: KEYNOTE-042: OS Benefit With Any Level of PD-L1 Expression
KEYNOTE-042 OS BENEFIT IN PATIENTS WITH ANY LEVEL OF PD-L1 EXPRESSION LEADERS IN DELIVERING BREAKTHROUGH INNOVATIONS THAT EXTEND AND IMPROVE TPS ≥ 1% TPS ≥ 20% TPS ≥ 50% 40.5% 44.7% 39.3% 28.0% 29.6% 30.1% • Best-in-class PARP inhibitor and Median (95% first CI) PARP in breast cancer Median (95% CI)
Slide 11: KEYNOTE-021G
KEYNOTE-021G 24-MONTH OS DATA LONG-TERM 100 70% 55% 67% 48% FOLLOW UP 90 DEMONSTRATES Overall Survival, % 80 70 60 CONTINUED 50 DURABILITY OF 40 30 CHEMO-COMBO 20 10 0 0 3 6 9 12 15 18 21 24 27 30 33 36 No. at risk Time, months 60 57 55 51 46 44 42 41 31 18 10 63 58 57 51 43 39 34 31 24 15 9 Events
Slide 12: Leaders in First-Line Lung Spanning 80% of NSCLC
LEADERS IN FIRST-LINE LUNG SPANNING 80% OF NSCLC Research & Development = Squamous PATIENTS EGFR / ALK = Nonsquamous SETTING THE PD-L1 < 1% PD-L1 < 1% BAR WITH PD-L1 1-49% PD-L1 > 50% OVERALL PD-L1 1-49% KEYNOTE-189 SURVIVAL PD-L1 > 50% 12
Slide 13: Expanding Footprint in Lung
EXPANDING FOOTPRINT IN LUNG BEYOND METASTATIC NSCLC REACHING EVEN MORE TYPES OF NSCLC Stages I - III LUNG CANCER Stage IV SCLC STAGE IV NSCLC STAGE III NSCLC SCLC KEYNOTE-001, 010, 024, KEYNOTE-091, 671, KEYNOTE-158 and -604 189, 042, 407 HOOSIER STUDY 13
Slide 14: Spotlight on Collaboration Data
KEYNOTE-054: Pembrolizumab versus placebo after complete resection of high- ASCO 2018 Melanoma risk stage III melanoma KEYNOTE-146 STUDY 08 SPOTLIGHT ON Multi-center, open-label Randomized, double-blinded, multi-center COLLABORATION Phase 1b/2 study of renal cell carcinoma as second-line combination
Slide 15: KEYNOTE-146
KEYNOTE-146 LENVIMA + KEYTRUDA FOR TREATMENT OF DEMONSTRATED PATIENTS WITH aRCC ANTITUMOR ACTIVITY AS 2L RCC THERAPY WITH ORR 70.0% PHASE 3 TRIALS IN 1L RCC UNDER WAY (KN-581 & KN-426) ALMOST ALL PATIENTS (N=29) EXPERIENCED TUMOR REDUCTION FROM BASELINE 15
Slide 16: Study 08: Lynparza + Abiraterone in Previously Treated mCRPC
STUDY 08 LYNPARZA + ABIRATERONE IN PATIENTS WITH FIRST PARP TO PREVIOUSLY TREATED mCRPC DEMONSTRATE Primary endpoint: investigator-assessed rPFS Olap +abi Abi ACTIVITY IN (n=71) (n=71) COMBINATION 1.0 Events, n (%) 46 (65) 54 (76) WITH STANDARD Proportion of patients event free KM median, months 13.
Slide 17: What to Watch: Next 18 Months
WHAT TO WATCH: NEXT 18 MONTHS* SELECT TRIAL October 2019 READ-OUTS February 2019 • 1L RCC COMBO: November 2018 • 2L+ HCC: KN–240 KN–581 • NEOADJ/ADJ – MONO/COMBO • 1L GASTRIC MONO/COMBO: KN–062 TNBC: KN–522 • NMIBC BLADDER: KN–057 Mid-2018 December 2018 June 2019 December 2019 • BRCAm 1L OVARIAN • 1
Slide 18: Q&A
Q&A CiK INVENTING FOR LIFE