Bavencio
Publisher: Datamonitor Healthcare
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Drug Overview
Bavencio (avelumab; Merck KGaA/Pfizer) is a fully human MAb targeting the PD-L1 protein. 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, Bavencio reduces the ability of the tumor to evade immune system targeting, and enables the activation of T cells and the adaptive immune system. In addition, preclinical and clinical studies have suggested that drugs targeting the PD-1/PD-L1 pathway may have fewer side effects than other immune checkpoint inhibitors.
Analyst Outlook
Bavencio (avelumab; Merck KGaA/Pfizer) in combination with Inlyta (axitinib; Pfizer) is in development as a first-line therapy for patients with advanced or metastatic renal cell carcinoma (RCC). If approved, this combination could be Pfizer’s fourth branded regimen in RCC, which will bolster the company’s strong standing within this market. Pfizer’s Sutent (sunitinib) is expected to lose
significant market share to the programmed death-1/programmed death-ligand 1 (PD-1/PD-L1) class. To defend and maintain its branded drug sales in RCC, Pfizer entered into an agreement to co-develop and commercialize Bavencio with Merck KGaA in combination with Inlyta as a potential replacement for Sutent. Competition in this treatment setting is likely to be fierce, as there are
four PD-1/PD-L1 inhibitors approved or in development for the lucrative first-line setting.
CONTENTS
6 OVERVIEW
6 Drug Overview
7 Product Profiles
7 Bavencio : Renal cell carcinoma (RCC)
16 Bavencio : NHL: Diffuse large B-cell lymphoma (DLBCL)
26 Bavencio : Non-small cell lung cancer (NSCLC)
38 Bavencio : Gastric cancer
53 Bavencio : Head and neck cancer
66 Bavencio : Ovarian cancer
77 Bavencio : Bladder cancer
LIST OF FIGURES
10 Figure 1: Bavencio for RCC – SWOT analysis
11 Figure 2: Datamonitor Healthcare’s drug assessment summary of Bavencio for RCC
12 Figure 3: Datamonitor Healthcare’s drug assessment summary of Bavencio for RCC
14 Figure 4: Bavencio sales for RCC across the US, Japan, and five major EU markets, by country, 2017–26
19 Figure 5: Bavencio for diffuse large B-cell lymphoma – SWOT analysis
20 Figure 6: Datamonitor Healthcare’s drug assessment summary for Bavencio in diffuse large B-cell lymphoma
21 Figure 7: Datamonitor Healthcare’s drug assessment summary for Bavencio in diffuse large B-cell lymphoma
23 Figure 8: Bavencio sales for diffuse large B-cell lymphoma across the US, Japan, and five major EU markets, by country, 2017–26
30 Figure 9: Bavencio for non-small cell lung cancer – SWOT analysis
31 Figure 10: Datamonitor Healthcare’s drug assessment summary for Bavencio in non-small cell lung cancer
32 Figure 11: Datamonitor Healthcare’s drug assessment summary for Bavencio in non-small cell lung cancer
34 Figure 12: Bavencio sales for NSCLC across the US, Japan, and five major EU markets, by country, 2017–26
45 Figure 13: Bavencio for gastric cancer – SWOT analysis
46 Figure 14: Datamonitor Healthcare’s drug assessment summary of Bavencio for gastric cancer
47 Figure 15: Datamonitor Healthcare’s drug assessment summary of Bavencio for gastric cancer
49 Figure 16: Bavencio sales for gastric cancer across the US, Japan, and five major EU markets, by country, 2017–26
58 Figure 17: Bavencio for head and neck cancer – SWOT analysis
59 Figure 18: Datamonitor Healthcare’s drug assessment summary of Bavencio for SCCHN
60 Figure 19: Datamonitor Healthcare’s drug assessment summary of Bavencio for SCCHN
62 Figure 20: Bavencio sales for SCCHN across the US, Japan, and five major EU markets, by country, 2017–26
72 Figure 21: Bavencio for ovarian cancer – SWOT analysis
73 Figure 22: Datamonitor Healthcare’s drug assessment of Bavencio for ovarian cancer
74 Figure 23: Datamonitor Healthcare’s drug assessment of Bavencio for ovarian cancer
81 Figure 24: Bavencio for urothelial bladder cancer – SWOT analysis
82 Figure 25: Datamonitor Healthcare’s drug assessment summary for Bavencio in urothelial bladder cancer
83 Figure 26: Datamonitor Healthcare’s drug assessment summary for Bavencio in urothelial bladder cancer
LIST OF TABLES
8 Table 1: Bavencio drug profile
9 Table 2: Bavencio Phase III data in RCC
15 Table 3: Bavencio sales for RCC across the US, Japan, and five major EU markets, by country ($m), 2017–26
16 Table 4: Bavencio drug profile
18 Table 5: Bavencio ongoing pivotal trial in diffuse large B-cell lymphoma
24 Table 6: Bavencio sales for diffuse large B-cell lymphoma across the US, Japan, and five major EU markets, by country ($m), 2017–26
26 Table 7: Bavencio drug profile
27 Table 8: Bavencio Phase III trials in non-small cell lung cancer
28 Table 9: Bavencio Phase III trial data in non-small cell lung cancer
29 Table 10: Bavencio early-phase data in non-small cell lung cancer
35 Table 11: Bavencio sales for NSCLC across the US, Japan, and five major EU markets, by country ($m), 2017–26
37 Table 12: Bavencio patient numbers for NSCLC across the US, Japan, and five major EU markets, by country, 2017–26
39 Table 13: Bavencio drug profile
40 Table 14: Bavencio Phase III trials in gastric cancer
42 Table 15: Bavencio Phase III trial data in gastric cancer
44 Table 16: Bavencio early-phase data in gastric cancer
50 Table 17: Bavencio sales for gastric cancer across the US, Japan, and five major EU markets, by country ($m), 2017–26
52 Table 18: Bavencio patient numbers for gastric cancer across the US, Japan, and five major EU markets, by country, 2017–26
54 Table 19: Bavencio drug profile
55 Table 20: Bavencio Phase III trials in head and neck cancer
57 Table 21: Bavencio early-phase data in head and neck cancer
63 Table 22: Bavencio sales for SCCHN across the US, Japan, and five major EU markets, by country ($m), 2017–26
65 Table 23: Bavencio patient numbers for SCCHN across the US, Japan, and five major EU markets, by country, 2017–26
67 Table 24: Bavencio drug profile
69 Table 25: Bavencio Phase III trials in ovarian cancer
72 Table 26: Overview of Phase I data for Bavencio in ovarian cancer
78 Table 27: Bavencio drug profile
79 Table 28: Bavencio pivotal trial data in urothelial bladder cancer
80 Table 29: Bavencio ongoing late-phase trials in urothelial bladder cancer
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