Keytruda
Author: Tara Hansen
Publisher: Datamonitor Healthcare
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Drug Overview
Keytruda (pembrolizumab; Merck & Co) is a humanized monoclonal antibody designed to inhibit the PD-1 co-inhibitory receptor. The interaction between PD-1 and its primary ligand, PD-L1, inhibits T-cell proliferation and survival, and induces apoptosis of tumor-specific T-cells. The disruption of this interaction reduces the ability of the tumor to evade immune system targeting and enhances antitumor immune responses. It has also been hypothesized that blocking the PD-1/PD-L1 interaction may preferentially release the cytotoxic function of tumor-specific T cells with fewer toxic effects than those seen with other immune checkpoint inhibitors.
CONTENTS
6 OVERVIEW
6 Drug Overview
7 Product Profiles
7 Keytruda : Breast cancer: triple-negative
15 Keytruda : Hepatocellular carcinoma (HCC)
25 Keytruda : Renal cell carcinoma (RCC)
36 Keytruda : NHL: Diffuse large B-cell lymphoma (DLBCL)
46 Keytruda : Non-small cell lung cancer (NSCLC)
67 Keytruda : Melanoma
82 Keytruda : Gastric cancer
97 Keytruda : Colorectal cancer (CRC)
112 Keytruda : Head and neck cancer
129 Keytruda : Bladder cancer
LIST OF FIGURES
13 Figure 1: Datamonitor Healthcare’s drug assessment summary of Keytruda for TNBC
13 Figure 2: Datamonitor Healthcare’s drug assessment summary of Keytruda for TNBC
21 Figure 3: Datamonitor Healthcare’s drug assessment summary of Keytruda for HCC
22 Figure 4: Datamonitor Healthcare’s drug assessment summary of Keytruda for HCC
24 Figure 5: Keytruda sales for HCC across the US, Japan, and five major EU markets, by country, 2018–27
30 Figure 6: Keytruda for RCC – SWOT analysis
31 Figure 7: Datamonitor Healthcare’s drug assessment summary of Keytruda for RCC
32 Figure 8: Datamonitor Healthcare’s drug assessment summary of Keytruda for RCC
34 Figure 9: Keytruda sales for RCC across the US, Japan, and five major EU markets, by country, 2017–26
39 Figure 10: Keytruda for diffuse large B-cell lymphoma – SWOT analysis
40 Figure 11: Datamonitor Healthcare’s drug assessment summary for Keytruda in diffuse large B-cell lymphoma
41 Figure 12: Datamonitor Healthcare’s drug assessment summary for Keytruda in diffuse large B-cell lymphoma
43 Figure 13: Keytruda sales for diffuse large B-cell lymphoma across the US, Japan, and five major EU markets, by country, 2017–26
57 Figure 14: Keytruda for non-small cell lung cancer – SWOT analysis
58 Figure 15: Datamonitor Healthcare’s drug assessment summary for Keytruda in non-small cell lung cancer
59 Figure 16: Datamonitor Healthcare’s drug assessment summary for Keytruda in non-small cell lung cancer
61 Figure 17: Keytruda sales for NSCLC across the US, Japan, and five major EU markets, by country, 2017–26
74 Figure 18: Keytruda in melanoma – SWOT analysis
75 Figure 19: Datamonitor Healthcare’s drug assessment summary of Keytruda for melanoma
76 Figure 20: Datamonitor Healthcare’s drug assessment summary of Keytruda for melanoma
78 Figure 21: Keytruda sales for melanoma across the US, Japan, and five major EU markets, by country, 2017–26
89 Figure 22: Keytruda for gastric cancer – SWOT analysis
90 Figure 23: Datamonitor Healthcare’s drug assessment summary of Keytruda for gastric cancer
91 Figure 24: Datamonitor Healthcare’s drug assessment summary of Keytruda for gastric cancer
93 Figure 25: Keytruda sales for gastric cancer across the US, Japan, and five major EU markets, by country, 2017–26
102 Figure 26: Keytruda for colorectal cancer – SWOT analysis
103 Figure 27: Datamonitor Healthcare’s drug assessment summary for Keytruda in colorectal cancer
104 Figure 28: Datamonitor Healthcare’s drug assessment summary for Keytruda in colorectal cancer
106 Figure 29: Keytruda sales for colorectal cancer across the US, Japan, and five major EU markets, by country, 2016–25
121 Figure 30: Keytruda for head and neck cancer – SWOT analysis
122 Figure 31: Datamonitor Healthcare’s drug assessment summary of Keytruda for SCCHN
123 Figure 32: Datamonitor Healthcare’s drug assessment summary of Keytruda for SCCHN
125 Figure 33: Keytruda sales for SCCHN across the US, Japan, and five major EU markets, by country, 2017–26
134 Figure 34: Keytruda for urothelial bladder cancer – SWOT analysis
135 Figure 35: Datamonitor Healthcare’s drug assessment summary for Keytruda in urothelial bladder cancer
136 Figure 36: Datamonitor Healthcare’s drug assessment summary for Keytruda in urothelial bladder cancer
LIST OF TABLES
8 Table 1: Recent high-impact events for Keytruda in TNBC
9 Table 2: Keytruda drug profile
11 Table 3: Late-phase trials of Keytruda for TNBC
12 Table 4: Keytruda for TNBC – SWOT analysis
15 Table 5: Recent high-impact events for Keytruda in HCC
16 Table 6: Keytruda drug profile
16 Table 7: Approval history of Keytruda for HCC in the US, Japan, and five major EU markets
18 Table 8: Trials of Keytruda for HCC
20 Table 9: Keytruda for HCC – SWOT analysis
25 Table 10: Keytruda drug profile
27 Table 11: Keytruda Phase III data in RCC
29 Table 12: Keytruda Phase III trials in RCC
35 Table 13: Keytruda sales for RCC across the US, Japan, and five major EU markets, by country ($m), 2017–26
36 Table 14: Keytruda drug profile
38 Table 15: Keytruda pivotal trial data in diffuse large B-cell lymphoma
44 Table 16: Keytruda sales for diffuse large B-cell lymphoma across the US, Japan, and five major EU markets, by country ($m), 2017–26
46 Table 17: Keytruda drug profile
48 Table 18: Keytruda pivotal trial data in non-small cell lung cancer
54 Table 19: Keytruda ongoing late-phase clinical trials in non-small cell lung cancer
62 Table 20: Keytruda sales for NSCLC across the US, Japan, and five major EU markets, by country ($m), 2017–26
64 Table 21: Keytruda patient numbers for NSCLC across the US, Japan, and five major EU markets, by country, 2017–26
68 Table 22: Keytruda drug profile
69 Table 23: Keytruda pivotal trial data in melanoma
73 Table 24: Keytruda ongoing clinical trials in melanoma
79 Table 25: Keytruda sales for melanoma across the US, Japan, and five major EU markets, by country ($m), 2017–26
81 Table 26: Keytruda patient numbers for melanoma across the US, Japan, and five major EU markets, by country, 2017–26
82 Table 27: Keytruda drug profile
84 Table 28: Keytruda pivotal trial data in gastric cancer
86 Table 29: Keytruda Phase III trials in gastric cancer
94 Table 30: Keytruda sales for gastric cancer across the US, Japan, and five major EU markets, by country ($m), 2017–26
96 Table 31: Keytruda patient numbers for gastric cancer across the US, Japan, and five major EU markets, by country, 2017–26
98 Table 32: Keytruda drug profile
99 Table 33: Keytruda Phase III trial in colorectal cancer
101 Table 34: Keytruda early-phase data in colorectal cancer
107 Table 35: Keytruda sales for colorectal cancer across the US, Japan, and five major EU markets, by country ($m), 2016–25
109 Table 36: Patients treated with Keytruda across the US, Japan, and five major EU markets, by country, 2016–25
112 Table 37: Keytruda drug profile
114 Table 38: Keytruda pivotal trial data in head and neck cancer
117 Table 39: Keytruda ongoing late-phase trials in head and neck cancer
120 Table 40: Keytruda early-phase data in head and neck cancer
126 Table 41: Keytruda sales for SCCHN across the US, Japan, and five major EU markets, by country ($m), 2017–26
128 Table 42: Keytruda patient numbers for SCCHN across the US, Japan, and five major EU markets, by country, 2017–26
130 Table 43: Keytruda drug profile
131 Table 44: Keytruda pivotal trial data in urothelial bladder cancer
132 Table 45: Keytruda ongoing late-phase trials in urothelial bladder cancer
133 Table 46: Keytruda early-phase data in urothelial bladder cancer
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