Lisocabtagene maraleucel (also known as JCAR017; Celgene) will be the third autologous chimeric antigen receptor T-cell (CAR-T) therapy to reach the diffuse large B-cell lymphoma (DLBCL) market following the launches of approved CAR-T drugs Kymriah (tisagenlecleucel; Novartis) and Yescarta (axicabtagene ciloleucel; Gilead). Lisocabtagene maraleucel has demonstrated comparable efficacy to Kymriah and Yescarta and a positive tolerability profile in the Phase I TRANSCEND trial (ClinicalTrials.gov identifier: NCT02631044) in relapsed/refractory DLBCL patients. These results will help lisocabtagene maraleucel to compete with the approved CAR-T therapies, as well as several pipeline regimens targeting relapsed/refractory patients.
Lisocabtagene maraleucel is an autologous T-cell therapy genetically engineered to express a CAR targeting cluster of differentiation (CD)19. CD19 is only expressed on B cells, thus it is an attractive target in B-cell leukemias and B-cell lymphomas. Studies suggest CD19 CAR-T cell-based immunotherapies effectively recognize and kill CD19-positive target cells and result in a high clinical response rate in the treatment of refractory B-cell malignancies, including DLBCL.
Lisocabtagene maraleucel (also known as JCAR017; Celgene) will be the third autologous chimeric antigen receptor T-cell (CAR-T) therapy to reach the diffuse large B-cell lymphoma (DLBCL) market following the launches of approved CAR-T drugs Kymriah (tisagenlecleucel; Novartis) and Yescarta (axicabtagene ciloleucel; Gilead). Lisocabtagene maraleucel has demonstrated comparable efficacy to Kymriah and Yescarta and a positive tolerability profile in the Phase I TRANSCEND trial (ClinicalTrials.gov identifier:NCT02631044) in relapsed/refractory DLBCL patients. These results will help lisocabtagene maraleucel to compete with the approved CAR-T therapies, as well as several pipeline regimens targeting relapsed/refractory patients.
CONTENTS
4 OVERVIEW
4 Drug Overview
5 Product Profiles
5 lisocabtagene maraleucel : NHL: Follicular lymphoma (FL)
15 lisocabtagene maraleucel : NHL: Diffuse large B-cell lymphoma (DLBCL)
LIST OF FIGURES
8 Figure 1: Lisocabtagene maraleucel for follicular lymphoma – SWOT analysis
9 Figure 2: Datamonitor Healthcare’s drug assessment summary of lisocabtagene maraleucel for follicular lymphoma
10 Figure 3: Datamonitor Healthcare’s drug assessment summary of lisocabtagene maraleucel for follicular lymphoma
12 Figure 4: Lisocabtagene maraleucel sales for follicular lymphoma across the US, Japan, and five major EU markets, by country, 2017–26
22 Figure 5: Lisocabtagene maraleucel for diffuse large B-cell lymphoma – SWOT analysis
23 Figure 6: Datamonitor Healthcare’s drug assessment summary for lisocabtagene maraleucel in diffuse large B-cell lymphoma
24 Figure 7: Datamonitor Healthcare’s drug assessment summary for lisocabtagene maraleucel in diffuse large B-cell lymphoma
26 Figure 8: Lisocabtagene maraleucel sales for diffuse large B-cell lymphoma across the US, Japan, and five major EU markets, by country, 2017–26
LIST OF TABLES
6 Table 1: Lisocabtagene maraleucel drug profile
7 Table 2: Lisocabtagene maraleucel ongoing pivotal trial in follicular lymphoma
13 Table 3: Lisocabtagene maraleucel sales for follicular lymphoma across the US, Japan, and five major EU markets, by country ($m), 2017–26
15 Table 4: Lisocabtagene maraleucel drug profile
17 Table 5: Lisocabtagene maraleucel pivotal trial data in diffuse large B-cell lymphoma
21 Table 6: Lisocabtagene maraleucel ongoing pivotal trial in diffuse large B-cell lymphoma
27 Table 7: Lisocabtagene maraleucel sales for diffuse large B-cell lymphoma across the US, Japan, and five major EU markets, by country ($m), 2017–26
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