Opdivo

CONTENTS

6 OVERVIEW
6 Drug Overview
7 Product Profiles
7 Opdivo : Hepatocellular carcinoma (HCC)
16 Opdivo : Renal cell carcinoma (RCC)
30 Opdivo : Non-small cell lung cancer (NSCLC)
49 Opdivo : Melanoma
66 Opdivo : Gastric cancer
80 Opdivo : Colorectal cancer (CRC)
94 Opdivo : Head and neck cancer
108 Opdivo : Bladder cancer

LIST OF FIGURES
12 Figure 1: Datamonitor Healthcare’s drug assessment summary of Opdivo for HCC
13 Figure 2: Datamonitor Healthcare’s drug assessment summary of Opdivo for HCC
15 Figure 3: Opdivo sales for HCC across the US and five major EU markets, by country, 2018–27
22 Figure 4: Opdivo for RCC – SWOT analysis
23 Figure 5: Datamonitor Healthcare’s drug assessment summary of Opdivo for RCC
24 Figure 6: Datamonitor Healthcare’s drug assessment summary of Opdivo for RCC
26 Figure 7: Opdivo sales for RCC across the US, Japan, and five major EU markets, by country, 2017–26
40 Figure 8: Opdivo for non-small cell lung cancer – SWOT analysis
41 Figure 9: Datamonitor Healthcare’s drug assessment summary for Opdivo in non-small cell lung cancer
42 Figure 10: Datamonitor Healthcare’s drug assessment summary for Opdivo in non-small cell lung cancer
44 Figure 11: Opdivo sales for NSCLC across the US, Japan, and five major EU markets, by country, 2017–26
57 Figure 12: Opdivo for melanoma – SWOT analysis
58 Figure 13: Datamonitor Healthcare’s drug assessment summary of Opdivo for melanoma
59 Figure 14: Datamonitor Healthcare’s drug assessment summary of Opdivo for melanoma
61 Figure 15: Opdivo sales for melanoma across the US, Japan, and five major EU markets, by country, 2017–26
72 Figure 16: Opdivo for gastric cancer – SWOT analysis
73 Figure 17: Datamonitor Healthcare’s drug assessment summary of Opdivo for gastric cancer
74 Figure 18: Datamonitor Healthcare’s drug assessment summary of Opdivo for gastric cancer
76 Figure 19: Opdivo sales for gastric cancer across the US, Japan, and five major EU markets, by country, 2017–26
85 Figure 20: Opdivo for colorectal cancer – SWOT analysis
86 Figure 21: Datamonitor Healthcare’s drug assessment summary of Opdivo for colorectal cancer
87 Figure 22: Datamonitor Healthcare’s drug assessment summary of Opdivo for colorectal cancer
89 Figure 23: Opdivo sales for colorectal cancer across the US and five major EU markets, by country, 2016–25
101 Figure 24: Opdivo for head and neck cancer – SWOT analysis
102 Figure 25: Datamonitor Healthcare’s drug assessment summary of Opdivo for SCCHN
103 Figure 26: Datamonitor Healthcare’s drug assessment summary of Opdivo for SCCHN
105 Figure 27: Opdivo sales for SCCHN across the US, Japan, and five major EU markets, by country, 2017–26
112 Figure 28: Opdivo for urothelial bladder cancer – SWOT analysis
113 Figure 29: Datamonitor Healthcare’s drug assessment summary for Opdivo in urothelial bladder cancer
114 Figure 30: Datamonitor Healthcare’s drug assessment summary for Opdivo in urothelial bladder cancer

LIST OF TABLES
7 Table 1: Recent high-impact events for Opdivo in HCC
8 Table 2: Opdivo drug profile
9 Table 3: Approval history of Opdivo for HCC in the US, Japan, and five major EU markets
10 Table 4: Trials of Opdivo for HCC
11 Table 5: Opdivo for HCC – SWOT analysis
16 Table 6: Opdivo drug profile
18 Table 7: Opdivo Phase III data in RCC
21 Table 8: Opdivo ongoing trials in RCC
27 Table 9: Opdivo sales for RCC across the US, Japan, and five major EU markets, by country ($m), 2017–26
30 Table 10: Opdivo drug profile
32 Table 11: Opdivo pivotal trial data in non-small cell lung cancer
35 Table 12: Opdivo CheckMate-026 Phase III data in non-small cell lung cancer
37 Table 13: Opdivo ongoing late-phase clinical trials in non-small cell lung cancer
45 Table 14: Opdivo sales for NSCLC across the US, Japan, and five major EU markets, by country ($m), 2017–26
47 Table 15: Opdivo patient numbers for NSCLC across the US, Japan, and five major EU markets, by country, 2017–26
50 Table 16: Opdivo drug profile
52 Table 17: Opdivo pivotal trial data in melanoma
56 Table 18: Opdivo ongoing late-phase clinical trials in melanoma
62 Table 19: Opdivo sales for melanoma across the US, Japan, and five major EU markets, by country ($m), 2017–26
64 Table 20: Opdivo patient numbers for melanoma across the US, Japan, and five major EU markets, by country, 2017–26
67 Table 21: Opdivo drug profile
68 Table 22: Opdivo pivotal trial data in gastric cancer
70 Table 23: Opdivo Phase III trials in gastric cancer
77 Table 24: Opdivo sales for gastric cancer across the US, Japan, and five major EU markets, by country ($m), 2017–26
79 Table 25: Opdivo patient numbers for gastric cancer across the US, Japan, and five major EU markets, by country, 2017–26
81 Table 26: Opdivo drug profile
82 Table 27: Opdivo pivotal trial data in colorectal cancer
84 Table 28: Opdivo early-phase trials in colorectal cancer
90 Table 29: Opdivo sales for colorectal cancer across the US and five major EU markets, by country ($m), 2016–25
92 Table 30: Patients treated with Opdivo across the US and five major EU markets, by country, 2016–25
94 Table 31: Opdivo drug profile
96 Table 32: Opdivo pivotal trial data in head and neck cancer
98 Table 33: Opdivo ongoing late-phase trials in head and neck cancer
106 Table 34: Opdivo sales for SCCHN across the US, Japan, and five major EU markets, by country ($m), 2017–26
108 Table 35: Opdivo patient numbers for SCCHN across the US, Japan, and five major EU markets, by country, 2017–26
109 Table 36: Opdivo drug profile
110 Table 37: Opdivo pivotal trial data in urothelial bladder cancer
111 Table 38: Opdivo ongoing late-phase trials in urothelial bladder cancer