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Kymriah

  • ID: 4775403
  • Report
  • January 2019
  • Region: Global
  • 38 pages
  • Datamonitor Healthcare
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Drug Overview
Kymriah (tisagenlecleucel; Novartis) is a cluster of differentiation (CD)19-targeted genetically modified autologous T-cell immunotherapy, comprised of a murine single-chain antibody fragment that binds CD19 and is linked to intracellular signaling domains from 4-1BB (CD137) and CD3 zeta. The CD3 zeta component helps to initiate T-cell activation, whereas the 4-1BB costimulatory domain facilitates expansion and persistence of the cells. Upon binding to CD19-expressing cells, Kymriah transmits a signal to promote T-cell expansion, activation, and target cell elimination.

Analyst Outlook
Kymriah (tisagenlecleucel; Novartis) is the second autologous chimeric antigen receptor T-cell (CAR-T) therapy to be approved for use in diffuse large cell B-cell lymphoma (DLBCL), and will face strong competition from the first-to-market CAR-T therapy Yescarta (axicabtagene ciloleucel; Gilead). The high cost of CAR-T treatment and logistical challenges surrounding manufacture of the regimen will remain a barrier to uptake. Kymriah will also face increasing competition from late-phase drugs targeting the relapsed/refractory settings, including ublituximab (TG Therapeutics/LFB Biotechnologies), umbralisib (TG Therapeutics/Rhizen), and late-phase CAR-T lisocabtagene maraleucel (Celgene). Despite these challenges, the durable response rates and acceptable safety profile demonstrated by Kymriah treatment in heavily pretreated patients will ensure continued revenue increases over the forecast period.
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OVERVIEW
Drug Overview
Product Profiles
Kymriah: Chronic lymphocytic leukemia (CLL)
Kymriah: NHL: Follicular lymphoma (FL)
Kymriah: NHL: Diffuse large B-cell lymphoma (DLBCL)

LIST OF FIGURES
Figure 1: The authors drug assessment summary of Kymriah for CLL
Figure 2: The authors drug assessment summary of Kymriah for CLL
Figure 3: Kymriah sales for CLL across the US and five major EU markets, by country, 2017–26
Figure 4: Kymriah for follicular lymphoma – SWOT analysis
Figure 5: The authors drug assessment summary of Kymriah for follicular lymphoma
Figure 6: The authors drug assessment summary of Kymriah for follicular lymphoma
Figure 7: Kymriah sales for follicular lymphoma across the US, Japan, and five major EU markets, by country, 2017–26
Figure 8: Kymriah for diffuse large B-cell lymphoma – SWOT analysis
Figure 9: The authors drug assessment summary for Kymriah in diffuse large B-cell lymphoma
Figure 10: The authors drug assessment summary for Kymriah in diffuse large B-cell lymphoma
Figure 11: Kymriah sales for diffuse large B-cell lymphoma across the US, Japan, and five major EU markets, by country, 2017–26

LIST OF TABLES
Table 1: Kymriah drug profile
Table 2: Trials of Kymriah for CLL
Table 3: Kymriah for CLL – SWOT analysis
Table 4: Kymriah drug profile
Table 5: Kymriah Phase IIa trial in follicular lymphoma
Table 6: Kymriah clinical trial data in follicular lymphoma
Table 7: Kymriah sales for follicular lymphoma across the US, Japan, and five major EU markets, by country ($m), 2017–26
Table 8: Kymriah drug profile
Table 9: Kymriah pivotal trial data in diffuse large B-cell lymphoma
Table 10: Kymriah early-phase trial data in diffuse large B-cell lymphoma
Table 11: Kymriah sales for diffuse large B-cell lymphoma across the US, Japan, and five major EU markets, by country ($m), 2017–26
Note: Product cover images may vary from those shown
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