Imfinzi (durvalumab; AstraZeneca) is a human monoclonal antibody directed against programmed death-ligand 1 (PD-L1). The interaction between PD-L1 and its receptor, programmed death-1 (PD-1), regulates complex signaling pathways that affect T-cell activation, proliferation, and survival, and can induce apoptosis of tumor-specific T cells. By inhibiting the PD-1/PD-L1 interaction, Imfinzi reduces the ability of the tumor to evade immune system targeting and enables the activation of T cells and the adaptive immune system
CONTENTS
5 OVERVIEW
5 Drug Overview
6 Product Profiles
6 Imfinzi : Hepatocellular carcinoma (HCC)
14 Imfinzi : Non-small cell lung cancer (NSCLC)
34 Imfinzi : Head and neck cancer
47 Imfinzi : Bladder cancer
LIST OF FIGURES
10 Figure 1: Datamonitor Healthcare’s drug assessment summary of Imfinzi for HCC
11 Figure 1: Datamonitor Healthcare’s assessment summary of key marketed and pipeline drugs for HCC
13 Figure 2: HCC total market value across the US, Japan, and five major EU markets, by country, 2018−27
25 Figure 4: HCC sales in Japan, 2018–27
26 Figure 5: HCC sales in the five major EU markets, by country, 2018–27
27 Figure 6: Datamonitor Healthcare’s drug assessment summary for Imfinzi in non-small cell lung cancer
29 Figure 7: Imfinzi sales for NSCLC across the US, Japan, and five major EU markets, by country, 2017–26
39 Figure 8: Imfinzi for head and neck cancer – SWOT analysis
40 Figure 6: Price sources and calculations, by country
43 Figure 7: Datamonitor Healthcare’s drug assessment summary of Cabometyx for HCC
52 Figure 9: Cabometyx sales for HCC across the US, Japan, and five major EU markets, by country, 2018–27
53 Figure 12: Datamonitor Healthcare’s drug assessment summary for Imfinzi in urothelial bladder cancer
LIST OF TABLES
7 Table 1: Imfinzi drug profile
8 Table 2: Trials of Imfinzi for HCC
9 Table 3: Imfinzi for HCC – SWOT analysis
14 Table 4: Imfinzi drug profile
16 Table 5: Imfinzi pivotal trial data in non-small cell lung cancer
18 Table 6: Imfinzi late-phase trial data in non-small cell lung cancer
22 Table 7: Imfinzi ongoing late-phase clinical trials in non-small cell lung cancer
30 Table 8: Imfinzi sales for NSCLC across the US, Japan, and five major EU markets, by country ($m), 2017–26
32 Table 9: Imfinzi patient numbers for NSCLC across the US, Japan, and five major EU markets, by country, 2017–26
34 Table 10: Imfinzi drug profile
36 Table 11: Imfinzi Phase III trials in head and neck cancer
38 Table 12: Imfinzi early-phase data in head and neck cancer
44 Table 13: Imfinzi sales for SCCHN across the US, Japan, and five major EU markets, by country ($m), 2017–26
46 Table 14: Imfinzi patient numbers for SCCHN across the US, Japan, and five major EU markets, by country, 2017–26
48 Table 15: Imfinzi drug profile
49 Table 16: Imfinzi pivotal trial data in urothelial bladder cancer
50 Table 17: Imfinzi ongoing late-phase trials in urothelial bladder cancer
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