MERCK ONCOLOGY OVERVIEW AACR 2018 APRIL 16, 2018

Similar documents
MERCK ONCOLOGY OVERVIEW ASCO 2018 JUNE 4, 2018

Merck Oncology Overview ASCO 2017

Merck Oncology Overview ASCO 2017

Merck Announces FDA Approval of KEYTRUDA. Provided to Investors as a Reference

Merck Oncology Overview. The Development of MSI-H Cancer Therapy. Development of Anti-Cancer Drugs Forum Tokyo, Japan, 18, February 2017

Merck ASCO 2015 Investor Briefing

Merck Pipeline. August 1, 2018

Merck Pipeline. November 1, 2017

Merck Pipeline. As of August 3, 2015

ASCO 2018 Investor Meeting

Beyond vaccine introduction: Working together for sustainable, resilient immunization programs Manufacturer perspective

Early Development of Immuno-oncology Drugs Novel Targets, Technology Platforms, and Trial Designs

3Q 2018 EARNINGS CALL. October 2018

Pursuing Precision in Immuno-Oncology Biology, Big data and Biomarkers

Wells Fargo Healthcare Conference September 6, 2018

Eisai Co,. Ltd. and Merck & Co., Inc., Kenilworth, N.J., U.S.A.

Neuroendokrine Tumorerkrankungen Immuntherapie. Ulrich Keilholz Charité Comprehensive Cancer Center

ICLIO National Conference

Click Here to Watch Video

Determined to realize a future in which people with cancer live longer and better than ever before Q Conference Call

ASCO 2018 investor event; breakout 2: Lynparza lifecycle; MRK collaboration

Merck and DNAtrix Announce Phase 2 Immuno-Oncology Collaboration in Patients with Aggressive Form of Brain Cancer

JP Morgan Healthcare Conference

Citi Global Healthcare Conference

Immune Checkpoint Inhibitors: The New Breakout Stars in Cancer Treatment

First Phase 3 Results Presented for a PD-1 Immune Checkpoint Inhibitor

News Release FOR IMMEDIATE RELEASE (908) (267) Amy Klug (908) Courtney Ronaldo (908)

ADAPTIMMUNE INVESTOR PRESENTATION. August 2016

ONO PHARMACEUTICAL CO., LTD. and Bristol-Myers Squibb Announce Strategic Immuno-Oncology Collaboration in Japan, South Korea and Taiwan

Cowen Health Care Conference

What we learned from immunotherapy in the past years

Keytruda. Keytruda (pembrolizumab) Description

ASCO 2014 Highlights*

Investor Call. May 19, Nasdaq: IMGN

Syndax Announces Updated Results from Phase 2 ENCORE 601 Trial of Entinostat in Combination with KEYTRUDA (pembrolizumab)

ESMO 2016 * Investor Meeting October 9, *European Society of Medical Oncology, October 7-11, 2016 ESMO 2016 NOT FOR PRODUCT PROMOTIONAL USE

U.S. Food and Drug Administration Accepts Supplemental Biologics License Application. for Opdivo (nivolumab)

Determined to realize a future in which people with cancer live longer and better than ever before CORPORATE PRESENTATION JUNE 2017

Metastatic NSCLC: Expanding Role of Immunotherapy. Evan W. Alley, MD, PhD Abramson Cancer Center at Penn Presbyterian

FORWARD II PROGRAM UPDATE

Leerink Immuno-Oncology Roundtable Conference

Ipsen announces CELESTIAL phase 3 pivotal trial results in the New England Journal of Medicine

FOR IMMEDIATE RELEASE Media Contact: Lainie Keller Investor Contacts: Teri Loxam (908) (908) Amy Klug (908)

Merck & Co., Inc. Adam H. Schechter Executive Vice President and President Global Human Health. Jefferies Global Healthcare Conference

ASCO 2016 * Investor Meeting June 4, *American Society of Clinical Oncology, June 3-7, 2016 ASCO 2016 NOT FOR PRODUCT PROMOTIONAL USE

The Current Status of Immune Checkpoint Inhibitors: Arvin Yang, MD PhD Oncology Global Clinical Research Bristol-Myers Squibb

Analyst/Investor Call

Release Date: Sunday, October 9, :16 am EDT. Dateline City: KENILWORTH, N.J.

Building a Premier Oncology Biotech

Determined to realize a future in which people with cancer live longer and better than ever before CORPORATE PRESENTATION SEPTEMBER 2017

Keytruda. Keytruda (pembrolizumab) Description

Determined to realize a future in which people with cancer live longer and better than ever before

Merck Pipeline. April 30, 2010

Media Contact: Ron Rogers Investor Contact: Scott Gleason (801) (801)

Attached from the following page is the press release made by BMS for your information.

Janssen Hematologic Malignancy Portfolio

Corporate Presentation May Transforming Immuno-Oncology Using Next-Generation Immune Cell Engagers

Dawson James Conference

Attached from the following page is the press release made by BMS for your information.

TARGET A BETTER NOW FORWARD-LOOKING STATEMENTS NASDAQ: IMGN. Current as of January 2018

Corporate Presentation March 2016

JP Morgan Healthcare Conference

Building a Premier Oncology Biotech

Attached from the following page is the press release made by BMS for your information.

33 rd Annual J.P. Morgan Healthcare Conference. January 2015

Citi s 13 th Annual Biotech Conference September 5, 2018

Investor Meetings October 2018

CORPORATE PRESENTATION

OncoSec Provides 2018 Business Outlook

Determined to realize a future in which people with cancer live longer and better than ever before

Investor Webcast: Initial Data from Phase 1a/1b Trial of Cabiralizumab/OPDIVO and Early Efficacy Signal in Pancreatic Cancer.

Determined to realize a future in which people with cancer live longer and better than ever before 4Q18 EARNINGS PRESENTATION MARCH 2019

Combining HS-110 and anti-pd-1 in NSCLC. September 1, 2015

July, ArQule, Inc.

Pfizer Presents Final Phase 2 Data on Investigational PARP Inhibitor Talazoparib in Patients with Germline BRCA-Positive Advanced Breast Cancer

National Bank 8th Annual Quebec Conference TSX: IMV. May 30, IMV Inc. All rights reserved.

Corporate Presentation October 2018 Nasdaq: ADXS

Clovis Oncology Announces Q Operating Results and Corporate Update. November 3, :05 PM ET

DS-8201 Strategic Collaboration

At the forefront of cancer immunotherapy. Investor Presentation January 2018

VeriStrat Poor Patients Show Encouraging Overall Survival and Progression Free Survival Signal; Confirmatory Phase 2 Study Planned by Year-End

Predictive Biomarkers for Pembrolizumab. Eric H. Rubin, M.D.

Leading the Next Wave of Biotech Breakthroughs

4 th Quarter 2017 Earnings Review & Investor Update

Genomic Health. Kim Popovits, Chairman, CEO and President

Role of the Pathologist in Guiding Immuno-oncological Therapies. Scott Rodig MD, PhD

37 th ANNUAL JP MORGAN HEALTHCARE CONFERENCE

Genta Incorporated. A Multiproduct Late-Stage Oncology Company

Arming the patient s immune system to fight cancer

CONSIDERATIONS IN DEVELOPMENT OF PEMBROLIZUMAB IN MSI-H CANCERS

Recurrent Ovarian Cancer Phase 1b Results

Third Quarter 2015 Earnings Call. November 9, 2015

Targeting the Tumor Locally

Determined to realize a future in which people with cancer live longer and better than ever before

At the forefront of cancer immunotherapy. Investor Presentation January 2018

Keytruda. Keytruda (pembrolizumab) Description

NewLink Genetics Corporation Provides Operational Update and Reports Second Quarter 2015 Financial Results

GSK Oncology. Axel Hoos, MD, PhD Senior Vice President, Oncology R&D. March 8, 2017

Use of Single-Arm Cohorts/Trials to Demonstrate Clinical Benefit for Breakthrough Therapies. Eric H. Rubin, MD Merck Research Laboratories

Transcription:

MERCK ONCOLOGY OVERVIEW AACR 2018 APRIL 16, 2018

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 statements are based upon the current beliefs and expectations of the company s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those 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 attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company s ability to 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 2017 Annual Report on Form 10-K and the company s other filings with the Securities and Exchange Commission (SEC) available at the SEC s Internet site (www.sec.gov). 2

MERCK ONCOLOGY 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 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

SIGNIFICANT PROGRESS IN ONCOLOGY OVER LAST FEW YEARS Assets under collaboration with our partners LEADERS IN DELIVERING BREAKTHROUGH Approximate INNOVATIONS THAT EXTEND number of patients AND IMPROVES Clinical trials ~200K 700+ studying over treated worldwide THE LIVES OF PEOPLE WITH with KEYTRUDA 30 tumor types CANCER Novel assets in the pipeline 20+ ~ 60 400+ Trials studying KEYTRUDA in combination 10 Approved indications Tumor types KEYTRUDA is showing activity in 25+ 7 Trials demonstrating overall survival 12 FDA Breakthrough Therapy Designations 4

KEYTRUDA DEMONSTRATED ANTI-TUMOR ACTIVITY IN MORE THAN 25 CANCER TYPES approved - - - under review 1. Daud A et al. ASCO 2015; 2. Garon EB et al. ESMO 2014; 3. Seiwert T et al. ASCO 2015; 4. Plimack E et al. ASCO 2015; 5. Nanda R et al. SABCS 2014; 6. Bang YJ et al. ASCO 2015 ; 7. Moskowitz C et al. ASH 2014; 8. Zinzani PL et al. ASH 2015; 9. Alley EA et al. AACR 2015; 10. Varga A et al. ASCO 2015; 11. Ott PA et al. 2015 ASCO; 12. Doi T et al. ASCO 2015; 13. Hsu C et al. ECC 2015; 14. Ott PA et al. ECC 2015; 15. Bang Y-J et al. ECC 2015; 16. O Neil B et al. ECC 2015; 17. Rugo HS et al. SABCS 2015; 18. Frenel JS et al. ASCO 2016; 19. Mehnert JM et al. ASCO 2016; 20. Cohen R et al. ASCO 2016; 21. Ott PA et al. ASCO 2016; 22. Hansen AR et al. ESMO 2016; 23. Reardeon D et al. SNO 2016; 24. Zhu A et al. ASCO GI 2018 5

KEYTRUDA: BUILDING MOMENTUM 10 APPROVED INDICATIONS Melanoma NSCLC Head and Neck Bladder Gastric TNBC Colorectal Hodgkin Lymphoma MSI-High Esophageal Renal Ovarian Cervical* Prostate Non-Hodgkin Lymphoma* Hepatocellular Other Thoracic Malignancies Gynecological Malignancies Rare Tumors WAVE 1 WAVE 2 WAVE 3 EXECUTING ON WAVE 2 & 3 WITH CONTINUED PROGRESS DEMONSTRATED OVERALL SURVIVAL IN 7 TRIALS *Currently under review by the FDA. 6

EXPANDING OUR ONCOLOGY PORTFOLIO THROUGH GLOBAL STRATEGIC COLLABORATIONS LEADERS IN DELIVERING BREAKTHROUGH INNOVATIONS THAT EXTEND AND IMPROVES THE LIVES OF PEOPLE WITH CANCER Best-in-class PARP inhibitor and first PARP in breast cancer Significant long-term opportunity across multiple tumors and treatment settings Breakthrough Therapy Designation in combination with World s first PARP inhibitor in breast cancer Broadest clinical development program KEYTRUDA in RCC Significant long-term opportunity across multiple tumors and treatment settings Broadest clinical development program Approved as monotherapy in RAI-refractory DTC* and in combination with everolimus in advanced RCC; approved in HCC in Japan and filed HCC in US, EU and China Initiating combination studies in 11 potential indications across 6 tumor types *Differentiated Thyroid Cancer 7

EXPLORING 20+ ASSETS IN ONCOLOGY PIPELINE STING Cavatak Immune Agonists RIG-I Other Agonists GITR Oncolytic Viruses IL-10 IDO+TDO, TDO Negative Immune Regulators LAG-3 TIGIT IDO CTLA-4 CTLA-4 Nab Multi-Specific Nabs CXCR2 Preclinical Programs Personalized Cancer Vaccines RNA-based vaccines Clinical Programs Tumor Microenvironment CDK 1,2,5,9 Olaparib Lenvatinib ERK Selumetinib 8

Melanoma KEYNOTE-189 KEYNOTE-054: Pembrolizumab versus placebo after complete resection of highrisk stage III melanoma KEYNOTE-054 AACR 2018 Randomized, Double-Blind, Phase 3 Study of Pembrolizumab or Placebo plus Pemetrexed and Platinum as First-Line Therapy for Metastatic NSCLC Pembrolizumab versus placebo after complete resection of high-risk stage III melanoma: Efficacy and safety results from the double-blinded Phase 3 trial DATA TO HIGHLIGHT 9

KEYNOTE-189 PHASE 3 TRIAL COMBINING KEYTRUDA AND CHEMOTHERAPY OS HR=0.49 [all comers] KEYTRUDA is the first immunotherapy in combination with chemotherapy to significantly extend survival in 1L nonsquamous NSCLC patients O S, % 100 90 80 70 60 50 40 30 20 10 Events HR (95% CI) P Pembro/Pem/Plat 31.0% 0.49 Placebo/Pem/Plat 52.4% (0.38-0.64) <0.00001 0 0 3 6 9 12 15 18 21 N o. at R isk Months 410 377 347 278 163 71 18 0 206 183 149 104 59 25 8 0 KEYTRUDA REDUCED THE RISK OF DEATH BY HALF COMPARED TO CHEMOTHERAPY ALONE 10

KEYNOTE-189 OS BENEFIT ACROSS ALL PD-L1 SUBGROUPS TPS <1% Events HR (95% CI) P a Pembro/Pem/Plat 38.6% 0.59 0.0095 Placebo/Pem/Plat 55.6% (0.38-0.92) O S, % 100 90 80 70 60 50 40 61.7% 52.2% O S, % 100 90 80 70 60 50 40 TPS 1-49% TPS 50% Events HR (95% CI) P a 28.9% 0.55 0.0081 48.3% (0.34-0.90) 71.5% 50.9% O S, % 100 90 80 70 60 50 40 Events HR (95% CI) P a 25.8% 0.42 0.0001 51.4% (0.26-0.68) 73.0% 48.1% OVERALL SURVIVAL IS THE GOLD STANDARD SETS THE BAR FOR FUTURE TRIALS IN 1L NSQ NSCLC 30 20 10 0 Median (95% CI) 15.2 mo (12.3-NE) 12.0 mo (7.0-NE) 0 3 6 9 12 15 18 21 30 20 10 0 Median (95% CI) NR (NE-NE) 12.9 mo (8.7-NE) 0 3 6 9 12 15 18 21 30 20 10 0 Median (95% CI) NR (NE-NE) 10.0 mo (7.5-NE) 0 3 6 9 12 15 18 21 Months N o. at R isk 127 113 104 79 42 20 6 0 63 54 45 32 21 6 1 0 Months N o. at R isk 128 119 108 84 52 21 5 0 58 54 47 32 17 5 2 0 Months N o. at R isk 132 122 114 96 56 25 6 0 70 64 50 35 19 13 4 0 a Nominal and one-sided. Data cutoff date: Nov 8, 2017. 11

Melanoma KEYNOTE-189 KEYNOTE-054: Pembrolizumab versus placebo after complete resection of highrisk stage III melanoma KEYNOTE-054 AACR 2018 Randomized, Double-Blind, Phase 3 Study of Pembrolizumab or Placebo plus Pemetrexed and Platinum as First-Line Therapy for Metastatic NSCLC Pembrolizumab versus placebo after complete resection of high-risk stage III melanoma: Efficacy and safety results from the double-blinded Phase 3 trial DATA TO HIGHLIGHT 12

KEYNOTE-054 PHASE 3 TRIAL STUDYING KEYTRUDA IN ADJUVANT MELANOMA HR=0.57 DATA DEMONSTRATE PROLONGED RECURRENCE FREE SURVIVAL (RFS) BENEFIT 43% reduction in risk of recurrence or death regardless of disease stage, PD-L1 expression or mutation status 13

WHAT TO WATCH: KEY DATA READ-OUTS OVER THE NEXT 18 MONTHS 1L NSCLC PD-L1 > 1%: KEYNOTE-042 2L HCC: KEYNOTE-224 1L SQ NSCLC COMBO: KEYNOTE-407 1L H&N MONO/COMBO: KEYNOTE-048 1L TNBC: KEYNOTE-522 2L+ TNBC: KEYNOTE-119 chl: KEYNOTE-204 1L GASTRIC MONO/COMBO: KEYNOTE-062 2L+ HCC: KEYNOTE-240 NMIBC BLADDER: KEYNOTE-057 1L BLADDER: KEYNOTE-361 BRCAm OVARIAN (LYNPARZA): SOLO-1 Research & Development 14

Q&A 15