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Bristol-Myers Squibb Breyanzi second-line treatment of large B-cell lymphoma
Bristol-Myers Squibb Breyanzi second-line treatment of large B-cell lymphoma. CD19 CAR-T cell therapy! Bristol-Myers Squibb Breyanzi second-line treatment of large B-cell lymphoma: the effect is better than standard care!
Bristol-Myers Squibb (BMS) recently announced the CD19 CAR-T cell therapy Breyanzi (lisocabtagene maraleucel, liso-cel) for the second-line treatment of relapsed or refractory large B-cell lymphoma (R/R LBCL) Phase 3 TRANSFORM study (NCT03575351) The positive top line result.
The results showed that among R/R LBCL patients eligible for stem cell transplantation, Breyanzi has a significant effect compared with the current standard care regimen including high-dose chemotherapy [HDCT] and hematopoietic stem cell transplantation [HSCT].
Breyanzi is an autologous, CD19-directed, chimeric antigen receptor (CAR) T cell therapy with a clear composition and 4-1BB costimulatory domain. Breyanzi is composed of purified CD8+ and CD4+ T cells in a specific ratio (1:1). The 4-1BB signal enhances the expansion and persistence of Breyanzi.
In February 2020, Breyanzi was approved by the US FDA for the treatment of adult patients with R/R LBCL who have previously received two or more systemic therapies, including diffuse large B-cell lymphoma (DLBCL, including DLBCL caused by indolent lymphoma), high-grade B-cell lymphoma (HGBL), primary mediastinal large B-cell lymphoma (PMBCL), and follicular lymphoma grade 3B. Breyanzi is not suitable for the treatment of patients with primary central nervous system (CNS) lymphoma.
TRANSFORM is a global, randomized, multi-center study conducted in adult patients with large B-cell lymphoma (LBCL) who are primarily refractory or relapse within 12 months after initial treatment and are eligible for stem cell transplantation. CD19 is being evaluated The efficacy and safety of CAR-T cell therapy Breyanzi (lisocabtagene maraleucel, liso-cel) for second-line treatment were compared with the current standard care regimen (including high-dose chemotherapy [HDCT] and hematopoietic stem cell transplantation [HSCT]).
The results of a pre-designated interim analysis conducted by the Independent Review Committee (IRC) showed that the study met the primary and key secondary endpoints: (1) Compared with standard care regimens, Breyanzi treatment achieved event-free survival (EFS). ) There are clinically significant and highly statistically significant improvements; (2) Compared with the standard care plan, Breyanzi also has a significant improvement in complete response rate (CR) and progression-free survival (PFS).
At the time of the interim analysis, overall survival (OS) data were not yet mature. The safety results are consistent with the known safety of Breyanzi’s third-line treatment of LBCL, and no new safety issues were found in the second-line treatment.
The TRANSFORM study results show for the first time that in patients with relapsed or refractory LBCL, a treatment method is more effective than standard high-dose chemotherapy and stem cell transplantation therapies, and for the first time proves the potential of CD19-directed CAR-T cell therapy as a second-line treatment.
BMS will complete the evaluation of the TRANSFORM research data and look forward to sharing the results at the upcoming medical meeting and communicating with regulatory agencies
(source:internet, reference only)