Gazyva
Publisher: Datamonitor Healthcare
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Drug Overview
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 Datamonitor Healthcare 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.
CONTENTS
4 OVERVIEW
4 Drug Overview
5 Product Profiles
5 Gazyva : Chronic lymphocytic leukemia (CLL)
16 Gazyva : NHL: Follicular lymphoma (FL)
33 Gazyva : NHL: Mantle cell lymphoma (MCL)
LIST OF FIGURES
11 Figure 1: Datamonitor Healthcare’s drug assessment summary of Gazyva for CLL
12 Figure 2: Datamonitor Healthcare’s drug assessment summary of Gazyva for CLL
14 Figure 3: Gazyva sales for CLL across the US and five major EU markets, by country, 2017–26
25 Figure 4: Gazyva for follicular lymphoma – SWOT analysis
26 Figure 5: Datamonitor Healthcare’s drug assessment summary of Gazyva for follicular lymphoma
27 Figure 6: Datamonitor Healthcare’s drug assessment summary of Gazyva for follicular lymphoma
29 Figure 7: Gazyva sales for follicular lymphoma across the US, Japan, and five major EU markets, by country, 2017–26
37 Figure 8: Gazyva for mantle cell lymphoma – SWOT analysis
LIST OF TABLES
5 Table 1: Gazyva drug profile
6 Table 2: Approval history of Gazyva for CLL in the US, Japan, and five major EU markets
8 Table 3: Trials of Gazyva for CLL
10 Table 4: Gazyva for CLL – SWOT analysis
17 Table 5: Gazyva drug profile
19 Table 6: Gazyva pivotal trial data in follicular lymphoma
22 Table 7: Gazyva other clinical trials in follicular lymphoma
24 Table 8: Gazyva ongoing late-phase clinical trials in follicular lymphoma
30 Table 9: Gazyva sales for follicular lymphoma across the US, Japan, and five major EU markets, by country ($m), 2017–26
34 Table 10: Gazyva drug profile
35 Table 11: Gazyva Phase I/II data in mantle cell lymphoma
36 Table 12: Gazyva Phase Ib/II trial in mantle cell lymphoma
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