CAR T cell therapy Breyanzi approved as relapsed or refractory large B-cell lymphoma second-line therapy in Japan
Bristol-Myers Squibb K.K. announced that it has received approval in Japan for Breyanzi (generic name: lisocabtagene maraleucel; liso-cel), a CD19-targeting chimeric antigen receptor (CAR) T cell therapy (gene-modified autologous therapy), allowing its use in the second-line treatment of relapsed or refractory large B-cell lymphoma (LBCL), regardless of whether autologous hematopoietic stem-cell transplantation is intended
This approval is based on the results of clinical trials in patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma after first-line therapy, including global Phase III clinical trials (JCAR017-BCM-003) in patients intended for autologous hematopoietic stem-cell transplantation, Phase II clinical trials (017006) in the United States (U.S.) in patients not intended for autologous hematopoietic stem-cell transplantation, and cohort 2 of Phase II clinical trials (JCAR017-BCM-001) in Europe and Japan.
The randomized controlled clinical trial (JCAR017-BCM003) is currently being conducted in a total of 184 patients (including nine Japanese patients) with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma after first-line therapy and intended for autologous hematopoietic stem-cell transplantation who were assigned to the Breyanzi arm or the standard therapy arm (salvage chemoimmunotherapy followed by high-dose chemotherapy combined with autologous hematopoietic stem-cell transplantation in patients with a response).
The interim analysis of the JCAR017-BCM-003 clinical trial reported that the Breyanzi arm showed a statistically and clinically significant improvement in the primary endpoint of event-free survival (EFS) [HR: 0.349 95% CI: 0.229-0.530, p<0.0001] and progression-free survival (pfs) [hr: 0.406 (95% ci: 0.250-0.659), p="0.0001]." median pfs was 14.8 months in the breyanzi arm (95% ci: 6.6-ne) and 5.7 months (95% ci: 3.9-9.4) in the standard therapy arm. in the breyanzi arm, the overall safety profile of patients who had relapsed or refractory lbcl with a prior treatment history of one regimen was similar to that of such patients with a prior treatment history of two regimens or more, with no new safety signals noted.
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