Kymriah
Publisher: 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.
CONTENTS
5 OVERVIEW
5 Drug Overview
6 Product Profiles
6 Kymriah : Chronic lymphocytic leukemia (CLL)
15 Kymriah : NHL: Follicular lymphoma (FL)
25 Kymriah : NHL: Diffuse large B-cell lymphoma (DLBCL)
LIST OF FIGURES
11 Figure 1: Datamonitor Healthcare’s drug assessment summary of Kymriah for CLL
12 Figure 2: Datamonitor Healthcare’s drug assessment summary of Kymriah for CLL
14 Figure 3: Kymriah sales for CLL across the US and five major EU markets, by country, 2017–26
18 Figure 4: Kymriah for follicular lymphoma – SWOT analysis
19 Figure 5: Datamonitor Healthcare’s drug assessment summary of Kymriah for follicular lymphoma
20 Figure 6: Datamonitor Healthcare’s drug assessment summary of Kymriah for follicular lymphoma
22 Figure 7: Kymriah sales for follicular lymphoma across the US, Japan, and five major EU markets, by country, 2017–26
30 Figure 8: Kymriah for diffuse large B-cell lymphoma – SWOT analysis
31 Figure 9: Datamonitor Healthcare’s drug assessment summary for Kymriah in diffuse large B-cell lymphoma
32 Figure 10: Datamonitor Healthcare’s drug assessment summary for Kymriah in diffuse large B-cell lymphoma
34 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
7 Table 1: Kymriah drug profile
9 Table 2: Trials of Kymriah for CLL
10 Table 3: Kymriah for CLL – SWOT analysis
15 Table 4: Kymriah drug profile
16 Table 5: Kymriah Phase IIa trial in follicular lymphoma
17 Table 6: Kymriah clinical trial data in follicular lymphoma
23 Table 7: Kymriah sales for follicular lymphoma across the US, Japan, and five major EU markets, by country ($m), 2017–26
25 Table 8: Kymriah drug profile
27 Table 9: Kymriah pivotal trial data in diffuse large B-cell lymphoma
29 Table 10: Kymriah early-phase trial data in diffuse large B-cell lymphoma
35 Table 11: Kymriah sales for diffuse large B-cell lymphoma across the US, Japan, and five major EU markets, by country ($m), 2017–26
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