MERCK ONCOLOGY OVERVIEW ASCO 2018 JUNE 4, 2018

Transcription

1 MERCK ONCOLOGY OVERVIEW ASCO 218 JUNE 4, 218

2 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 These statements are based upon the curr ent beliefs and expectations of the company s management and are subject to significant risks and uncertainties. There can be no guarantees w ith respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commerciall y successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from thos e set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents atta ined by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company s ability t o accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward -looking statements can be found in the company s 217 Annual Report on Form 1-K and the company s other filings with the Securities and Exchange Commission (SEC) available at the SEC s Internet site ( 2

3 Explore combinations and other novel agents to broaden our portfolio in an effort to reach more patients Establish KEYTRUDA as foundational treatment in monotherapy and in combination across multiple tumor types and stages of disease Identify Identify patients most likely to benefit through evaluation of biomarkers MERCK ONCOLOGY A LEADER IN DELIVERING BREAKTHROUGH APPROACHES THAT EXTEND AND IMPROVE THE LIVES OF PEOPLE WITH CANCER Advance internal pipeline and pursue strategic collaborations and acquisitions to expand oncology portfolio 3

4 ASCO: BREADTH OF DATA FROM EXPANSIVE CLINICAL PROGRAM LUNG RENAL CELL CERVICAL MERKEL CELL 25+ TUMOR TYPES 14 ABSTRACTS ACCEPTED FROM OUR BROAD ONCOLOGY PORTFOLIO PROSTATE ENDOMETRIAL HEAD AND NECK ESOPHAGEAL MELANOMA OVARIAN 4

5 Melanoma KEYNOTE-54: Pembrolizumab versus placebo after complete resection of highrisk stage III melanoma ASCO 218 KEYNOTE-47 Randomized, double-blind, placebo controlled, Phase 3 study in patients with metastatic squamous NSCLC KEYNOTE-42 Randomized, open-label Phase 3 study in patients with locally advanced or metastatic PD-L1 positive (TPS > 1%) NSCLC KEYNOTE-21G Multicenter, open-label, Phase 1/2 multi-cohort study in patients with metastatic, nonsquamous NSCLC SPOTLIGHT ON NSCLC 5

6 O S, % KEYNOTE-47 DEMONSTRATES SIGNIFICANT IMPROVEMENT IN OS HR =.64 [95% CI, ] KEYTRUDA is the first immunotherapy in combination with chemotherapy to significantly extend survival in 1L squamous NSCLC patients N o. a t R is k 82.6% 76.1% M o n th s Events HR (95% CI) P Pembro + Chemo 3.6%.64 Placebo + Chemo 42.7% ( ) mo (13.2-NE) 11.3 mo ( ).8 KEYTRUDA REDUCED RISK OF DEATH BY 36% COMPARED TO CHEMO ALONE Data cutoff date: Apr 3,

7 O S, % O S, % O S, % KEYNOTE-47 OS BENEFIT ACROSS ALL PD-L1 SUBGROUPS TPS <1% Events HR (95% CI) Pembro + Chemo 3.5%.61 ( ) Placebo + Chemo 44.4% 8.7% 79.4% 15.9 mo (13.1-NE) 1.2 mo ( ) Events TPS 1-49% TPS 5% HR (95% CI) 3.1%.57 (.36-.9) 43.3% 84.5% 76.% 14. mo (12.8-NE) 11.6 mo ( ) Events HR (95% CI) 31.5%.64 ( ) 41.1% 81.9% 71.3% NR (11.3 mo-ne) NR (7.4 mo-ne) FIFTH KEYTRUDA PHASE 3 TRIAL TO DEMONSTRATE IMPROVED SURVIVAL BENEFIT IN METASTATIC NSCLC M o n t h s M o n t h s M o n t h s N o. a t R is k N o. a t R is k N o. a t R is k Data cutoff date: Apr 3,

8 O S, % O S, % O S, % KEYNOTE-189 (AACR 218) OS BENEFIT ACROSS ALL PD-L1 SUBGROUPS TPS <1% Events HR (95% CI) P a Pembro/Pem/Plat 38.6%.59 Placebo/Pem/Plat 55.6% ( ) % 52.2% Events TPS 1-49% TPS 5% HR (95% CI) P a 28.9% % (.34-.9) 71.5% 5.9% Events HR (95% CI) P a 25.8% % ( ) 73.% 48.1%.1 OVERALL SURVIVAL IS THE GOLD STANDARD SETS THE BAR FOR FUTURE TRIALS IN 1L NSQ NSCLC mo (12.3-NE) 12. mo (7.-NE) NR (NE-NE) 12.9 mo (8.7-NE) NR (NE-NE) 1. mo (7.5-NE) M o n t h s N o. a t R is k M o n t h s N o. a t R is k M o n t h s N o. a t R is k a Nominal and one-sided. Data cutoff date: Nov 8,

9 KEYNOTE-42 PHASE 3 TRIAL STUDYING KEYTRUDA IN METASTATIC NONSQ AND SQ NSCLC AT TPS > 1% Events HR (95% CI) P Pembrolizumab Chemotherapy 438 ( ) % 28.% HR=.81 [95% CI, ] 16.7 mo ( ) 12.1 mo ( ) SIGNIFICANT IMPROVEMENT IN OVERALL SURVIVAL IN PATIENTS WITH PD-L1 >1% Entire study population with TPS > 1% 9

10 KEYNOTE-42 OS BENEFIT IN PATIENTS WITH ANY LEVEL OF PD-L1 EXPRESSION LEADERS IN DELIVERING BREAKTHROUGH INNOVATIONS TPS 1% THAT EXTEND TPS 2% AND IMPROVE TPS 5% 39.3% 28.% Best-in-class PARP inhibitor and first PARP in breast cancer 16.7 mo ( ) 12.1 mo ( ) Significant long-term opportunity across multiple tumors and treatment settings Broadest clinical development program 4.5% 29.6% 17.7 mo ( ) 13. mo ( ) 44.7% 3.1% 2. mo ( ) 12.2 mo ( ) Events HR (95% CI) P Pembrolizumab Chemotherapy 438 ( ) Events HR (95% CI) P Pembrolizumab Chemotherapy 266 ( ) Events HR (95% CI) P Pembrolizumab Chemotherapy 199 ( ) 1

11 Overall Survival, % KEYNOTE-21G 24-MONTH OS DATA 1 9 7% 55% 67% 48% Time, months No. at risk LONG-TERM FOLLOW UP DEMONSTRATES CONTINUED DURABILITY OF CHEMO-COMBO Events Median, mo (95% CI) HR (95% CI) Pembrolizumab +PC 22/6 NR (24.5-NR).56 PC alone 35/ (14.9-NR) ( ) P

12 LEADERS IN FIRST-LINE LUNG Research & Development = Squamous SPANNING 8% OF NSCLC PATIENTS PD-L1 < 1% EGFR / ALK = Nonsquamous PD-L1 1-49% PD-L1 < 1% PD-L1 1-49% PD-L1 > 5% KEYNOTE-189 PD-L1 > 5% 12

13 EXPANDING FOOTPRINT IN LUNG BEYOND METASTATIC NSCLC NSCLC Stages I - III REACHING EVEN MORE TYPES OF LUNG CANCER SCLC Stage IV SCLC KEYNOTE-158 and -64 STAGE IV NSCLC KEYNOTE-1, 1, 24, 189, 42, 47 STAGE III NSCLC KEYNOTE-91, 671, HOOSIER STUDY 13

14 Melanoma KEYNOTE-54: Pembrolizumab versus placebo after complete resection of highrisk stage III melanoma ASCO 218 KEYNOTE-146 Multi-center, open-label Phase 1b/2 study of renal cell carcinoma as second-line combination therapy (lenvatinib + pembrolizumab) STUDY 8 Randomized, double-blinded, multi-center Phase 2 trial, comparing LYNPARZA in combination with abiraterone to abiraterone monotherapy alone in patients with previously treated mcrpc SPOTLIGHT ON COLLABORATION DATA 14

15 KEYNOTE-146 LENVIMA + KEYTRUDA FOR TREATMENT OF PATIENTS WITH arcc DEMONSTRATED ANTITUMOR ACTIVITY AS 2L RCC THERAPY WITH ORR 7.% PHASE 3 TRIALS IN 1L RCC UNDER WAY (KN-581 & KN-426) ALMOST ALL PATIENTS (N=29) EXPERIENCED TUMOR REDUCTION FROM BASELINE 15

16 Proportion of patients event free STUDY 8 LYNPARZA + ABIRATERONE IN PATIENTS WITH PREVIOUSLY TREATED mcrpc Olap +abi (n=71) Abi (n=71) Events, n (%) 46 (65) 54 (76) KM median, months HR.65 95% CI.44,.97; P=.34 FIRST PARP TO DEMONSTRATE ACTIVITY IN COMBINATION WITH STANDARD OF CARE IN PROSTATE CANCER N at risk Time from randomization (months) Olaparib + abiraterone arm Abiraterone arm

17 WHAT TO WATCH: NEXT 18 MONTHS * SELECT TRIAL READ-OUTS November 218 NEOADJ/ADJ MONO/COMBO TNBC: KN 522 February 219 2L+ HCC: KN 24 1L GASTRIC MONO/COMBO: KN 62 NMIBC BLADDER: KN 57 October 219 1L RCC COMBO: KN 581 Mid-218 BRCAm 1L OVARIAN (LYNPARZA) SOLO 1 December 218 1L H&N MONO/COMBO: KN 48 2L+ TNBC: KN 119 chl: KN 24 June 219 1L BLADDER MONO/COMBO: KN 361 December 219 1L TNBC: KN 355 *Dates based on clinicaltrials.gov as of 6/4/18: All trials are event-driven FDA ACTION DATES 218 JUNE 28 Cervical KN 158 JULY 3 PMBCL KN 173 AUG 24 HCC (LENVIMA) DEC 28 2L H&N KN 4 SEPT 23 1L NSCLC KN 189

18 Q&A 18