Merck & Company, Inc. · NYSE:MRK
Merck & — Merck ASCO Event 2016
18 slides from Merck &'s conference presentation, Jun 6, 2016
Slide 1: Merck ASCO Event
Merck & Co., Inc. Merck ASCO Event June 6, 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: Agenda
Agenda • Strategy Overview • Combination Strategy • Biomarker Strategy • Closing and Q&A 3
Slide 4: Merck's Strategy in Oncology
Merck’s Strategy in Oncology Improve long-term disease control and survival across a wide range of cancers Establish KEYTRUDA as a foundation for the treatment of cancer in monotherapy and in combinations Identify patients most likely to benefit from KEYTRUDA 4
Slide 5: KEYTRUDA Program Accomplishments to Date
KEYTRUDA Program Accomplishments to Date In 5 years since entering clinical development First anti-PD-1 to market in the U.S. Approvals in melanoma and 2L PD-L1+ NSCLC Demonstrated overall survival - vs. ipilimumab in melanoma - vs. docetaxel in 2L PD-L1+ NSCLC Filed in Head and Neck Cancer
Slide 6: ASCO 2016: Continuing to Demonstrate Breadth and Depth of the Potential for KEYTRUDA
ASCO 2016: Continuing to Demonstrate Breadth and Depth of the Potential for KEYTRUDA >80 Abstracts Data in ~20 tumor types Overall Survival data in Melanoma and NSCLC Long-term follow-up in Head and Neck Cancer Early evidence from 1 Abstract ~10 combinations KEYNOTE-001 Melanoma ASCO 2013 ASCO 2016
Slide 7: Global Opportunity: Launching In More than 50 Markets
Global Opportunity: Launching In More than 50 Markets 1 = Melanoma = Lung 1. Europe: markets depicted on map with dots include France, Germany, Spain, Italy, UK & Switzerland. Additional 24 EU markets shaded green include Slovakia, Czech, Hungary, Finland, Estonia, Latvia, Lithuania, Poland, Denmark
Slide 8: The Broadest Program of Any Anti-PD-1/PD-L1 Drug
The Broadest Program of Any Anti-PD-1/PD-L1 Drug More than 270 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 (KN053/0
Slide 9: Keytruda Monotherapy Has Shown Activity in Tumors
Keytruda Monotherapy Has Shown Activity in 20 Tumors Melanoma1 100 NSCLC2 100 H&N3 100 Urothelial4 100 TNBC5 Gastric6 cHL7 100 100 100 0 0 0 0 0 0 0 Change From Baseline in Tumor Size, % -100 -100 -100 -100 -100 -100 -100 NHL PMBCL8 Mesothelioma9 Ovarian10 SCLC11 Esophageal12 NPC13 Anal14 100 100 10
Slide 10: ASCO Monotherapy Data Demonstrate Overall Survival In Ipilimumab-Naive Melanoma
ASCO Monotherapy Data Demonstrate Overall Survival In Ipilimumab-Naive Melanoma Arm Events, n HR (95% CI) P Overall Survival 1 Pembro Q2W 122 0.68 (0.53-0.87) 0.00085 Pembro Q3W 119 0.68 (0.53-0.86) 0.00083 Ipi 142 — — 100 74% 55% 90 68% 55% 80 59% 43% 70 % 60 NR (22.1-NR) 50 NR (23.5-NR) O S, 40 16
Slide 11: Improving Efficacy with Selective Combination Therapy
Improving Efficacy with Selective Combination Therapy More than 100 combination trials ongoing Combination Strategy Standard Targeted Immuno- Novel Therapies Therapies modulators Vaccines 11
Slide 12: KEYTRUDA-Based Combinations Show Potential for Enhanced Activity In Many Tumor Types
KEYTRUDA-Based Combinations Show Potential for Enhanced Activity In Many Tumor Types Standard Targeted Therapies Therapies 2 2 1 4 5 Combination Strategy 6 3 3 Novel Immuno- Vaccines modulators 1. Data on file; 2. Papadimitrakopoulou V et al. ASCO 2015; 3. Gangadhar T et al. SITC 2015; 4. San Miguel
Slide 13: ASCO Data Demonstrate Further Progress with Combinations
ASCO Data Demonstrate Further Progress with Combinations KEYNOTE-021: 1L NSCLC1 KEYNOTE-023: KEYTRUDA + lenalidomide and low-dose Cohort A Cohort B Cohort C All Patients dexamathasone in relapsed/refractory KEYTRUDA + KEYTRUDA + KEYTRUDA + 100 Multiple Myeloma2 Percent change from baseline paclitaxe
Slide 14: Internal Pipeline Further Enables Combination Strategy
Internal Pipeline Further Enables Combination Strategy GITR (MK-4166) GITR (MK-1248) Immune Agonists Program 1 Program 2 IL-10 (MK-1966) TDO Negative CEACAM1 (MK-6018) Multi-specific nanobodies Immune Regulators LAG-3 (MK-4280) Program 3 IDO Program 4 Tumor PI3K Delta (MK-1822) CDK 1,2,5,9 (MK-7965)
Slide 15: Biologic Rationale for Predictive Biomarkers
Biologic Rationale for Predictive Biomarkers Increased Antigen Ligand Expression Immunogenic Presentation Due on Tumor Microenvironment to High DNA Mutation Load Immune-Related Gene DNA Mismatch Repair PD-L1 and PD-L2 Expression (GEP) Deficiency, DNA Expression Signature Polymerase Mutation 15
Slide 16: ASCO Data Demonstrate the Potential Importance of Patient Selection Through PD-L1, MMR-Deficiency, and IFN-γ Markers
ASCO Data Demonstrate the Potential Importance of Patient Selection Through PD-L1, MMR-Deficiency, and IFN-γ Markers KEYNOTE-016 KEYNOTE-012 Durability of Disease Control in IFN-γ 6-gene Signature Score significantly associated MMR-Deficient Tumors1 with Overall Survival in Head and Neck Cancer2 Ove
Slide 17: What to Expect From Merck Oncology in 2016
What to Expect From Merck Oncology in 2016 Additional internally-owned programs to enter the clinic Filings in additional tumor types • Anticipated approval in Head and Neck Cancer (U.S.) • Anticipated approvals from KEYNOTE-010 filings in 2L PD-L1+ NSCLC • Results from 1L NSCLC Study, KEYNOTE-0
Slide 18: Q&A
Roger M. Perlmutter Frank Clyburn Executive Vice President and President President Merck Oncology Merck Research Laboratories Q&A