Merck & Company, Inc. · NYSE:MRK
Merck & — ASCO 2017
20 slides from Merck &'s conference presentation, Jun 5, 2017
Slide 1: Merck Oncology Overview
Merck Oncology Overview ASCO 2017 June 5, 2017
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 1995
Slide 3: Merck Oncology Strategy
Merck 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 immun
Slide 4: 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 Ongoing Roughly 40 launches Broadest PD-1 / ongoing around the PD-L1 program registration- world in multiple enabling studies settings • More than 500 trials in • FDA Breakthrough • First PD-1 to market in more than 30 t
Slide 5: KEYTRUDA monotherapy has shown activity in more than 20 tumors
KEYTRUDA monotherapy has shown activity in more than 20 tumors resulting in approvals across 5 tumor types Melanoma1 100 NSCLC2 100 H&N3 100 Urothelial4 100 TNBC5 Gastric6 cHL7 NHL PMBCL8 100 100 100 100 0 0 0 0 0 0 0 0 Change From Baseline in Tumor Size, % -100 -100 -100 -100 -100 -100 -100 -100 Me
Slide 6: KEYTRUDA has also demonstrated improvements in overall survival
KEYTRUDA has also demonstrated improvements in overall survival... 1L NSCLC1 2L NSCLC2 Overall Survival % 1L Melanoma3 2L Bladder4 Time in Months 6 1. Section 14.2, Figure 3, KEYTRUDA prescribing information; 2. Section 14.2, Figure 4, KEYTRUDA prescribing information; 3. Section 14.1, Figure 1, KEY
Slide 7: Many additional registration-enabling studies in monotherapy and combination underway
…with many additional registration-enabling studies in monotherapy and combination currently underway ONGOING REGISTRATION-ENABLING TRIALS Head and Neck Triple Negative Breast Melanoma 1L + Chemo (KN355) 1L + chemo/cetuximab (KN048) 2L+ (KN086) Adjuvant (KN054) 2L (KN040) 1L + T-Vec (Amgen) 2L Nasop
Slide 8: ASCO 2017: Findings from more than 50 abstracts across 16 cancer types
ASCO 2017: Findings from more than 50 abstracts across 16 different types of cancer were presented • KEYNOTE-021G: + Pemetrexed and Carboplatin as 1L – Poster Lung • KEYNOTE-024: vs. Chemo as 1L NSCLC (TPS≥50%) Update – Oral • KEYNOTE-052: 1L bladder – Oral GU & GI • KEYNOTE-045: 2L bladder – Oral •
Slide 9: Lung
• KEYNOTE-021G: + Pemetrexed and Carboplatin as 1L – Poster Lung • KEYNOTE-024: vs. Chemo as 1L NSCLC (TPS≥50%) Update – Oral 9
Slide 10: KEYNOTE-21G: Beginning to show trend to OS benefit
KEYNOTE-21G: Beginning to show trend to OS benefit with further follow-up (not statistically significant) • KN-021G approved based on significant improvement in ORR and PFS • Trend toward OS benefit is emerging despite the high rate of crossover (75%) 10
Slide 11: KEYNOTE-024: OS benefit continues through 2 years; PFS2 analysis
KEYNOTE-024: OS benefit continues through 2-years & exploratory analysis of PFS2 shows KEYTRUDA as initial therapy provided overall better disease control Overall Survival PFS2 • Continued to show OS benefit over • PFS2 was substantially improved for chemo as 1L therapy for mNSCLC patients in the pe
Slide 12: GU & GI
• KEYNOTE-045: 2L bladder – Oral GU & GI • KEYNOTE-052: 1L bladder – Oral • KEYNOTE-059: 3L gastric – Oral 12
Slide 13: KEYNOTE-045 & KEYNOTE-052: Approved in U.S. for urothelial cancer
KEYNOTE-045 & KEYNOTE-052: Approved in U.S. for treatment of urothelial cancer in 2L based on OS & in cisplatin-ineligible patients (1L) based on ORR • KEYNOTE-045: Only PD-1 / PD-L1 to show OS in 2L setting [HR = 0.70 OS (p-value 0.0004)] • KEYNOTE-052: ORR of 29% in all patients 13
Slide 14: KEYNOTE-059, cohort 1: Antitumor activity in advanced gastric cancer
KEYNOTE-059, cohort 1: Promising antitumor activity in patients with advanced gastric cancer progressing after ≥2 prior lines of therapy • 11.6% ORR in total patient population (N=259) o 15.5% ORR in PD-L1 positive patients o 6.4% in PD-L1 negative patients • sBLA accepted for Priority Review with P
Slide 15: Breast
• KEYNOTE-173: Neoadjuvant TNBC – Oral Breast • I-SPY 2 TRIAL: Neoadjuvant TNBC & HR+ – Oral 15
Slide 16: KEYNOTE-173 & I-SPY 2 TRIAL: Early promise of chemo-combo in breast cancer
KEYNOTE-173 & I-SPY 2 TRIAL: Early promise of chemo-combo in breast cancer • KEYNOTE-173: Promising preliminary data add to the growing body of evidence for KEYTRUDA activity in breast cancer • I-SPY 2 TRIAL: Nearly tripled pCR rate for HR+/HER2- patients and tripled pCR rate for TNBC patients The B
Slide 17: Tremendous progress establishing KEYTRUDA across many tumor types
Tremendous progress so far in establishing KEYTRUDA as an important cancer treatment across many tumor types, with much more to come… Esophageal Renal Ovarian Prostate HeadBladder and Neck Multiple Myeloma Gastric* Non-Hodgkin Lymphoma TNBC Hepatocellular Colorectal Other Thoracic Malignancies
Slide 18: Internal oncology pipeline to further enhance KEYTRUDA activity
We have established an internal oncology pipeline focused on agents that could further enhance KEYTRUDA activity GITR (MK-4166) GITR (MK-1248) Immune Agonists STING (MK-1454) Other Agonists IL-10 (MK-1966) TDO LAG-3 (MK-4280) CTLA4 (MK-1308) Immune Antagonists TIGIT (MK-7684) Multi-specific nanobodi
Slide 19: Merck Oncology Strategy
Merck 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 immun
Slide 20: Q&A
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