Gazyva (obinutuzumab; Roche/Biogen/Chugai/Nippon Shinyaku) Overview 2019: A Third-Generation, Type II Glycoengineered, Humanized Anti-CD20 Monoclonal Antibody (MAb) - ResearchAndMarkets.com

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Gazyva (obinutuzumab; Roche/Biogen/Chugai/Nippon Shinyaku) is a third-generation, type II glycoengineered, humanized anti-CD20 monoclonal antibody (MAb) that recognizes the type II epitope of the CD20 antigen expressed on the surface of pre-B and mature-B lymphocytes. Gazyva mediates B-cell lysis through engagement of immune effector cells, by direct cell death, and by activation of the complement cascade.

Due to its reduced fucose content, Gazyva exhibits increased antibody-dependent cellular cytotoxicity than Rituxan (rituximab; Roche/Biogen/Chugai/Zenyaku Kogyo) in vitro in human cancer cell lines, and improves survival in xenograft models of diffuse large B-cell lymphoma and mantle cell lymphoma. As opposed to Rituxan, which is a type I anti-CD20 MAb, this third-generation anti-CD20 MAb is a stronger inducer of direct cell death and antibody-dependent cellular cytotoxicity.

Type II anti-CD20 MAbs have also demonstrated less dependence on complement-dependent cytotoxicity, which is an immune response that involves a series of proteins known as the complement system. Complement activation by Rituxan has been associated with infusion-related side effects of the drug.

Analyst Outlook

Gazyva (obinutuzumab; Roche/Biogen/Chugai/Nippon Shinyaku) gained approval for the treatment of Rituxan (rituximab; Roche/Biogen/Chugai/Zenyaku Kogyo)-refractory follicular lymphoma (FL) in combination with Treanda (bendamustine; Teva), followed by Gazyva monotherapy, in February 2016.

The drug is Roche's third-generation anti-CD20 monoclonal antibody (MAb), and is positioned as a potential replacement for Rituxan in the FL market. Gazyva will experience greater uptake with an anticipated label expansion into the lucrative first-line treatment setting, but the author believes that the drug's pricing strategy will be a major determinant for its success. Roche will have to balance the desire to maximize payback on its investment with its need to enhance its market penetration.

Key Topics Covered:

OVERVIEW

Drug Overview

Product Profiles

Gazyva: Chronic lymphocytic leukemia (CLL)

Gazyva: NHL: Follicular lymphoma (FL)

Gazyva: NHL: Mantle cell lymphoma (MCL)

LIST OF FIGURES

Figure 1: The authors drug assessment summary of Gazyva for CLL

Figure 2: Gazyva sales for CLL across the US and five major EU markets, by country, 2017-26

Figure 3: Gazyva for follicular lymphoma - SWOT analysis

Figure 4: The authors drug assessment summary of Gazyva for follicular lymphoma

Figure 5: Gazyva sales for follicular lymphoma across the US, Japan, and five major EU markets, by country, 2017-26

Figure 6: Gazyva for mantle cell lymphoma - SWOT analysis

LIST OF TABLES

Table 1: Gazyva drug profile

Table 2: Approval history of Gazyva for CLL in the US, Japan, and five major EU markets

Table 3: Trials of Gazyva for CLL

Table 4: Gazyva for CLL - SWOT analysis

Table 5: Gazyva drug profile

Table 6: Gazyva pivotal trial data in follicular lymphoma

Table 7: Gazyva other clinical trials in follicular lymphoma

Table 8: Gazyva ongoing late-phase clinical trials in follicular lymphoma

Table 9: Gazyva sales for follicular lymphoma across the US, Japan, and five major EU markets, by country ($m), 2017-26

Table 10: Gazyva drug profile

Table 11: Gazyva Phase I/II data in mantle cell lymphoma

Table 12: Gazyva Phase Ib/II trial in mantle cell lymphoma

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