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▎Bristol-Myers Squibb (BMS), the editor of WuXi AppTec's content team, announced today that its CD19-targeted CAR-T cell therapy Breyanzi (lisocabtagene maraleucel) has reached the primary and key secondary endpoints in a phase 3 clinical trial.
Compared with treatment, it significantly improves the event-free survival, complete remission rate and progression-free survival of patients with relapsed/refractory large B-cell lymphoma (LBCL)
.
The press release states that this is the first treatment in this patient group that has shown clinical benefit compared to standard second-line treatment
.
Breyanzi is an autologous CAR-T cell therapy targeting CD19 antigen.
It was approved by the US FDA in February 2021 for the treatment of adult patients with relapsed/refractory LBCL who have received two or more systemic treatments
.
The uniqueness of this therapy is that the ratio of CD8-positive and CD4-positive T cells in CAR-T therapy is controlled, which can better control the side effects of cell therapy
.
A randomized double-blind pivotal Phase 3 clinical trial called TRANSFORM was launched in adult patients with large B-cell lymphoma who relapsed within 12 months of receiving initial treatment
.
The trial evaluated Breyanzi's efficacy compared with current standard treatment regimens, including high-dose chemotherapy and hematopoietic stem cell transplantation
.
This study reached the primary endpoint, which was a clinically significant and statistically significant improvement in event-free survival compared to standard treatment
.
Breyanzi achieved both the complete remission rate and the key secondary endpoints of improvement in progression-free survival
.
The safety aspect is consistent with the results of previous studies
.
Dr.
Noah Berkowitz, Senior Vice President of Hematology and Cell Therapy Development at Bristol-Myers Squibb said: "These positive interim research results underscore Breyanzi's potential to change the treatment model for relapsed/refractory LBCL, a difficult-to-treat disease
.
" [1] Bristol Myers Squibb Announces Positive Topline Results from Phase 3 TRANSFORM Trial Evaluating Breyanzi (lisocabtagene maraleucel) Versus Chemotherapy Followed by Stem Cell Transplant in Second-line Relapsed or Refractory Large B-cell Lymphoma.
June 10, 2021, from https:/ /news.
bms.
com/news/corporate-financial/2021/Bristol-Myers-Squibb-Announces-Positive-Topline-Results-from-Phase-3-TRANSFORM-Trial-Evaluating-Breyanzi-lisocabtagene-maraleucel-Versus-Chemotherapy -Followed-by-Stem-Cell-Transplant-in-Second-line-Relapsed-or-Refractory-Large-B-cell-Lymphoma/default.
aspx Note: This article aims to introduce the progress of medical and health research, not a treatment plan recommendation
.
If you need guidance on the treatment plan, please go to a regular hospital for treatment
.
Compared with treatment, it significantly improves the event-free survival, complete remission rate and progression-free survival of patients with relapsed/refractory large B-cell lymphoma (LBCL)
.
The press release states that this is the first treatment in this patient group that has shown clinical benefit compared to standard second-line treatment
.
Breyanzi is an autologous CAR-T cell therapy targeting CD19 antigen.
It was approved by the US FDA in February 2021 for the treatment of adult patients with relapsed/refractory LBCL who have received two or more systemic treatments
.
The uniqueness of this therapy is that the ratio of CD8-positive and CD4-positive T cells in CAR-T therapy is controlled, which can better control the side effects of cell therapy
.
A randomized double-blind pivotal Phase 3 clinical trial called TRANSFORM was launched in adult patients with large B-cell lymphoma who relapsed within 12 months of receiving initial treatment
.
The trial evaluated Breyanzi's efficacy compared with current standard treatment regimens, including high-dose chemotherapy and hematopoietic stem cell transplantation
.
This study reached the primary endpoint, which was a clinically significant and statistically significant improvement in event-free survival compared to standard treatment
.
Breyanzi achieved both the complete remission rate and the key secondary endpoints of improvement in progression-free survival
.
The safety aspect is consistent with the results of previous studies
.
Dr.
Noah Berkowitz, Senior Vice President of Hematology and Cell Therapy Development at Bristol-Myers Squibb said: "These positive interim research results underscore Breyanzi's potential to change the treatment model for relapsed/refractory LBCL, a difficult-to-treat disease
.
" [1] Bristol Myers Squibb Announces Positive Topline Results from Phase 3 TRANSFORM Trial Evaluating Breyanzi (lisocabtagene maraleucel) Versus Chemotherapy Followed by Stem Cell Transplant in Second-line Relapsed or Refractory Large B-cell Lymphoma.
June 10, 2021, from https:/ /news.
bms.
com/news/corporate-financial/2021/Bristol-Myers-Squibb-Announces-Positive-Topline-Results-from-Phase-3-TRANSFORM-Trial-Evaluating-Breyanzi-lisocabtagene-maraleucel-Versus-Chemotherapy -Followed-by-Stem-Cell-Transplant-in-Second-line-Relapsed-or-Refractory-Large-B-cell-Lymphoma/default.
aspx Note: This article aims to introduce the progress of medical and health research, not a treatment plan recommendation
.
If you need guidance on the treatment plan, please go to a regular hospital for treatment
.
