CONTENTS

5 OVERVIEW

7 ABOUT THE AUTHORS

8 IMMUNO-ONCOLOGY OVERVIEW
8 Immuno-oncology mechanisms and timelines
9 PD-1 and PD-L1 inhibition

11 CLINICAL TRIAL LANDSCAPE
11 Active trials
14 Therapies in competitive trials
17 Trends in trial durations
18 Trial outcomes

20 CLINICAL DEVELOPMENT BENCHMARKS
20 Development landscape
21 Probability of success, likelihood of approval, and time to market

24 COMMERCIAL MARKET POTENTIAL
24 Patient potential
26 Competitive landscape
29 Market forecast

32 CHALLENGES AND EMERGING DYNAMICS
32 Differentiation and combinations in the PD-1/L1 class
33 PD-L1 and TMB as biomarkers
36 Upcoming catalysts

39 BIBLIOGRAPHY

LIST OF FIGURES
9 Figure 1: Timeline for first approvals of IO drugs in the US, 2010–18
10 Figure 2: PD-L1 expression by tumor cells to evade immune system
12 Figure 3: Competitive PD-1/L1 trials by phase and status
13 Figure 4: Trials of IO agents in NSCLC initiated from 2013–18
14 Figure 5: Top 10 sponsors of competitive IO NSCLC trials
15 Figure 6: Top five approved and unapproved IO therapies, ranked by number of active NSCLC trials
16 Figure 7: Ongoing or planned combination trials of IO agents in NSCLC
17 Figure 8: Average trial enrollment and treatment periods for NSCLC IO trials, 2008–18
19 Figure 9: Outcomes of NSCLC IO trials, 2013–18
20 Figure 10: Development status of PD-1/L1 agents in oncology
22 Figure 11: Phase transition benchmarks of the leading IO drug classes
22 Figure 12: Development timelines for PD-1/L1 in NSCLC, by clinical stage
25 Figure 13: Incident cases of NSCLC in the US, Japan, and five major EU markets, by country, 2017–37
26 Figure 14: Treatment snapshot and patient segmentation for NSCLC
27 Figure 15: Treatment algorithm for advanced or metastatic NSCLC in the US
29 Figure 16: Comparative assessment of PD-1/L1 inhibitors in NSCLC
30 Figure 17: NSCLC sales across the US, Japan, and five major EU markets, by drug class, 2017–26
31 Figure 18: PD-1/L1 inhibitor sales in NSCLC across the US, Japan, and five major EU markets, 2017–26
34 Figure 19: Potential near-term segmentation of first-line NSCLC patients
36 Figure 20: TMB trials ranked by top five industry sponsors, primary drugs, indications, and status
37 Figure 21: Expected repositioning of the PD-1/L1 class by January 2020

LIST OF TABLES
18 Table 1: Average trial enrollment and treatment periods for NSCLC IO trials, by phase, 2013–18
38 Table 2: High-impact catalysts for IO therapies in the NSCLC market, 2018–19