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.
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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