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Bavencio (avelumab; Merck KGaA/Pfizer) Drug Overview 2019

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    Drug Pipelines

  • 86 Pages
  • March 2019
  • Region: Global
  • Citeline
  • ID: 4462234
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.

Table of Contents

OVERVIEW
  • Drug Overview
  • Product Profiles
  • Bavencio: Renal cell carcinoma (RCC)
  • Bavencio: NHL: Diffuse large B-cell lymphoma (DLBCL)
  • Bavencio: Non-small cell lung cancer (NSCLC)
  • Bavencio: Gastric cancer
  • Bavencio: Head and neck cancer
  • Bavencio: Ovarian cancer
  • Bavencio: Bladder cancer

LIST OF FIGURES
Figure 1: Bavencio for RCC – SWOT analysis
Figure 2: The author's drug assessment summary of Bavencio for RCC
Figure 3: The author's drug assessment summary of Bavencio for RCC
Figure 4: Bavencio sales for RCC across the US, Japan, and five major EU markets, by country, 2017–26
Figure 5: Bavencio for diffuse large B-cell lymphoma – SWOT analysis
Figure 6: The author's drug assessment summary for Bavencio in diffuse large B-cell lymphoma
Figure 7: The author's drug assessment summary for Bavencio in diffuse large B-cell lymphoma
Figure 8: Bavencio sales for diffuse large B-cell lymphoma across the US, Japan, and five major EU markets, by country, 2017–26
Figure 9: Bavencio for non-small cell lung cancer – SWOT analysis
Figure 10: The author's drug assessment summary for Bavencio in non-small cell lung cancer
Figure 11: The author's drug assessment summary for Bavencio in non-small cell lung cancer
Figure 12: Bavencio sales for NSCLC across the US, Japan, and five major EU markets, by country, 2017–26
Figure 13: Bavencio for gastric cancer – SWOT analysis
Figure 14: The author's drug assessment summary of Bavencio for gastric cancer
Figure 15: The author's drug assessment summary of Bavencio for gastric cancer
Figure 16: Bavencio sales for gastric cancer across the US, Japan, and five major EU markets, by country, 2017–26
Figure 17: Bavencio for head and neck cancer – SWOT analysis
Figure 18: The author's drug assessment summary of Bavencio for SCCHN
Figure 19: The author's drug assessment summary of Bavencio for SCCHN
Figure 20: Bavencio sales for SCCHN across the US, Japan, and five major EU markets, by country, 2017–26
Figure 21: Bavencio for ovarian cancer – SWOT analysis
Figure 22: The author's drug assessment of Bavencio for ovarian cancer
Figure 23: The author's drug assessment of Bavencio for ovarian cancer
Figure 24: Bavencio for urothelial bladder cancer – SWOT analysis
Figure 25: The author's drug assessment summary for Bavencio in urothelial bladder cancer
Figure 26: The author's drug assessment summary for Bavencio in urothelial bladder cancer
LIST OF TABLES
Table 1: Bavencio drug profile
Table 2: Bavencio Phase III data in RCC
Table 3: Bavencio sales for RCC across the US, Japan, and five major EU markets, by country ($m), 2017–26
Table 4: Bavencio drug profile
Table 5: Bavencio ongoing pivotal trial in diffuse large B-cell lymphoma
Table 6: Bavencio sales for diffuse large B-cell lymphoma across the US, Japan, and five major EU markets, by country ($m), 2017–26
Table 7: Bavencio drug profile
Table 8: Bavencio Phase III trials in non-small cell lung cancer
Table 9: Bavencio Phase III trial data in non-small cell lung cancer
Table 10: Bavencio early-phase data in non-small cell lung cancer
Table 11: Bavencio sales for NSCLC across the US, Japan, and five major EU markets, by country ($m), 2017–26
Table 12: Bavencio patient numbers for NSCLC across the US, Japan, and five major EU markets, by country, 2017–26
Table 13: Bavencio drug profile
Table 14: Bavencio Phase III trials in gastric cancer
Table 15: Bavencio Phase III trial data in gastric cancer
Table 16: Bavencio early-phase data in gastric cancer
Table 17: Bavencio sales for gastric cancer across the US, Japan, and five major EU markets, by country ($m), 2017–26
Table 18: Bavencio patient numbers for gastric cancer across the US, Japan, and five major EU markets, by country, 2017–26
Table 19: Bavencio drug profile
Table 20: Bavencio Phase III trials in head and neck cancer
Table 21: Bavencio early-phase data in head and neck cancer
Table 22: Bavencio sales for SCCHN across the US, Japan, and five major EU markets, by country ($m), 2017–26
Table 23: Bavencio patient numbers for SCCHN across the US, Japan, and five major EU markets, by country, 2017–26
Table 24: Bavencio drug profile
Table 25: Bavencio Phase III trials in ovarian cancer
Table 26: Overview of Phase I data for Bavencio in ovarian cancer
Table 27: Bavencio drug profile
Table 28: Bavencio pivotal trial data in urothelial bladder cancer
Table 29: Bavencio ongoing late-phase trials in urothelial bladder cancer