Opdivo
Publisher: Datamonitor Healthcare
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Drug Overview
Opdivo (nivolumab; Bristol-Myers Squibb/Ono Pharmaceutical) is a fully human immunoglobulin G4 PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 expressed on activated T-cells. PD-1 and its ligands, PD-L1 and PD-L2, are members of the cluster of differentiation 28 and B7 family. The B7 family cell surface molecules and the cytotoxic T-lymphocyte antigen 4 family both regulate complex signaling pathways that affect T-cell activation, tolerance, and immunopathology. Blocking the interaction of the PD-1 receptor with its ligands may allow T cells to restore an anti-tumor immune response.
Analyst Outlook
Due to Opdivo’s (nivolumab; Bristol-Myers Squibb/Ono Pharmaceutical) first-in-class status, and development in combination with key therapies, it is set to be one of the highest grossing drugs in renal cell carcinoma (RCC) over the 10-year forecast period. Opdivo was the first programmed death-1 (PD-1) inhibitor approved for the treatment of RCC, initially approved as a monotherapy for the treatment of advanced RCC in patients who have received prior angiogenic therapy. While Opdivo’s uptake based on this initial approval was strong, significant growth is expected following approvals of Opdivo in combination with other therapies. These include the approval of Opdivo + Yervoy (ipilimumab; Bristol-Myers Squibb/Ono Pharmaceutical) for use in the first line irrespective of programmed death-ligand 1 (PD-L1) expression, which was based on strong clinical trial data from CheckMate 214 (ClinicalTrials.gov identifier: NCT02231749). Despite the considerable competition expected due to the launches of numerous therapies over the forecast period, Opdivo is set to extend its share of first- and second-line patients.
CONTENTS
6 OVERVIEW
6 Drug Overview
7 Product Profiles
7 Opdivo : Renal cell carcinoma (RCC)
22 Opdivo : Non-small cell lung cancer (NSCLC)
41 Opdivo : Melanoma
58 Opdivo : Gastric cancer
72 Opdivo : Colorectal cancer (CRC)
86 Opdivo : Head and neck cancer
100 Opdivo : Hepatocellular carcinoma (HCC)
110 Opdivo : Bladder cancer
LIST OF FIGURES
14 Figure 1: Opdivo for RCC – SWOT analysis
15 Figure 2: Datamonitor Healthcare’s drug assessment summary of Opdivo for RCC
16 Figure 3: Datamonitor Healthcare’s drug assessment summary of Opdivo for RCC
18 Figure 4: Opdivo sales for RCC across the US, Japan, and five major EU markets, by country, 2017–26
32 Figure 5: Opdivo for non-small cell lung cancer – SWOT analysis
33 Figure 6: Datamonitor Healthcare’s drug assessment summary for Opdivo in non-small cell lung cancer
34 Figure 7: Datamonitor Healthcare’s drug assessment summary for Opdivo in non-small cell lung cancer
36 Figure 8: Opdivo sales for NSCLC across the US, Japan, and five major EU markets, by country, 2017–26
49 Figure 9: Opdivo for melanoma – SWOT analysis
50 Figure 10: Datamonitor Healthcare’s drug assessment summary of Opdivo for melanoma
51 Figure 11: Datamonitor Healthcare’s drug assessment summary of Opdivo for melanoma
53 Figure 12: Opdivo sales for melanoma across the US, Japan, and five major EU markets, by country, 2017–26
64 Figure 13: Opdivo for gastric cancer – SWOT analysis
65 Figure 14: Datamonitor Healthcare’s drug assessment summary of Opdivo for gastric cancer
66 Figure 15: Datamonitor Healthcare’s drug assessment summary of Opdivo for gastric cancer
68 Figure 16: Opdivo sales for gastric cancer across the US, Japan, and five major EU markets, by country, 2017–26
77 Figure 17: Opdivo for colorectal cancer – SWOT analysis
78 Figure 18: Datamonitor Healthcare’s drug assessment summary of Opdivo for colorectal cancer
79 Figure 19: Datamonitor Healthcare’s drug assessment summary of Opdivo for colorectal cancer
81 Figure 20: Opdivo sales for colorectal cancer across the US and five major EU markets, by country, 2016–25
93 Figure 21: Opdivo for head and neck cancer – SWOT analysis
94 Figure 22: Datamonitor Healthcare’s drug assessment summary of Opdivo for SCCHN
95 Figure 23: Datamonitor Healthcare’s drug assessment summary of Opdivo for SCCHN
97 Figure 24: Opdivo sales for SCCHN across the US, Japan, and five major EU markets, by country, 2017–26
105 Figure 25: Opdivo for HCC – SWOT analysis
106 Figure 26: Datamonitor Healthcare’s drug assessment summary of Opdivo for HCC
107 Figure 27: Datamonitor Healthcare’s drug assessment summary of Opdivo for hepatocellular carcinoma
114 Figure 28: Opdivo for urothelial bladder cancer – SWOT analysis
115 Figure 29: Datamonitor Healthcare’s drug assessment summary for Opdivo in urothelial bladder cancer
116 Figure 30: Datamonitor Healthcare’s drug assessment summary for Opdivo in urothelial bladder cancer
LIST OF TABLES
8 Table 1: Opdivo drug profile
10 Table 2: Opdivo Phase III data in RCC
13 Table 3: Opdivo ongoing trials in RCC
19 Table 4: Opdivo sales for RCC across the US, Japan, and five major EU markets, by country ($m), 2017–26
22 Table 5: Opdivo drug profile
24 Table 6: Opdivo pivotal trial data in non-small cell lung cancer
27 Table 7: Opdivo CheckMate-026 Phase III data in non-small cell lung cancer
29 Table 8: Opdivo ongoing late-phase clinical trials in non-small cell lung cancer
37 Table 9: Opdivo sales for NSCLC across the US, Japan, and five major EU markets, by country ($m), 2017–26
39 Table 10: Opdivo patient numbers for NSCLC across the US, Japan, and five major EU markets, by country, 2017–26
42 Table 11: Opdivo drug profile
44 Table 12: Opdivo pivotal trial data in melanoma
48 Table 13: Opdivo ongoing late-phase clinical trials in melanoma
54 Table 14: Opdivo sales for melanoma across the US, Japan, and five major EU markets, by country ($m), 2017–26
56 Table 15: Opdivo patient numbers for melanoma across the US, Japan, and five major EU markets, by country, 2017–26
59 Table 16: Opdivo drug profile
60 Table 17: Opdivo pivotal trial data in gastric cancer
62 Table 18: Opdivo Phase III trials in gastric cancer
69 Table 19: Opdivo sales for gastric cancer across the US, Japan, and five major EU markets, by country ($m), 2017–26
71 Table 20: Opdivo patient numbers for gastric cancer across the US, Japan, and five major EU markets, by country, 2017–26
73 Table 21: Opdivo drug profile
74 Table 22: Opdivo pivotal trial data in colorectal cancer
76 Table 23: Opdivo early-phase trials in colorectal cancer
82 Table 24: Opdivo sales for colorectal cancer across the US and five major EU markets, by country ($m), 2016–25
84 Table 25: Patients treated with Opdivo across the US and five major EU markets, by country, 2016–25
86 Table 26: Opdivo drug profile
88 Table 27: Opdivo pivotal trial data in head and neck cancer
90 Table 28: Opdivo ongoing late-phase trials in head and neck cancer
98 Table 29: Opdivo sales for SCCHN across the US, Japan, and five major EU markets, by country ($m), 2017–26
100 Table 30: Opdivo patient numbers for SCCHN across the US, Japan, and five major EU markets, by country, 2017–26
101 Table 31: Opdivo drug profile
102 Table 32: Opdivo Phase III trial in HCC
104 Table 33: Opdivo Phase I/II data in HCC
111 Table 34: Opdivo drug profile
112 Table 35: Opdivo pivotal trial data in urothelial bladder cancer
113 Table 36: Opdivo ongoing late-phase trials in urothelial bladder cancer
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