95.5% of patients with relapsed or refractory marginal zone lymphoma (MZL) treated with lisocabtagene maraleucel (liso-cel) achieved a response, with 62.1% achieving complete response and 88.6% maintaining a response at 24 months
New data show liso-cel demonstrated high rates of durable responses and a consistent safety profile in a fifth cancer type, the most of any CD19-directed CAR T cell therapy
Additional liso-cel data at ICML 2025 further reinforce BMS’ commitment to unlocking the full potential of this therapy for patients
PRINCETON, NJ, USA I June 16, 2025 I Bristol Myers Squibb (NYSE: BMY) today announced the first disclosure of the primary analysis results of the marginal zone lymphoma (MZL) cohort of TRANSCEND FL, an open-label, global, multicenter, Phase 2, single-arm study evaluating Breyanzi (lisocabtagene maraleucel; liso-cel) in patients with relapsed or refractory disease. The new data will be presented at the 2025 International Conference on Malignant Lymphoma (ICML) in an oral presentation on June 19, building on positive topline results announced in February.
$BMY to present data highlighting #CARTcelltherapy advances for patients with relapsed or refractory blood cancers at #18ICML.
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“Liso-cel achieved high, lasting response rates in patients with relapsed or refractory marginal zone lymphoma, underscoring the potential of this one-time therapy to significantly improve patient outcomes,” said M. Lia Palomba, M.D., TRANSCEND FL study investigator and lymphoma and cell therapy specialist, Memorial Sloan Kettering Cancer Center. “Currently, the median survival for patients with marginal zone lymphoma with multiple relapses is 3 to 5 years, signifying an urgent need for transformative therapies that can effectively address this hard-to-treat disease.”
The MZL cohort of TRANSCEND FL enrolled adults with relapsed or refractory disease treated with liso-cel in the third-line plus setting. Patients received treatment with liso-cel at a target dose of 100 x 106 CAR-positive viable T cells.
In efficacy-evaluable patients with relapsed or refractory MZL treated with liso-cel (n=66), liso-cel demonstrated clinically meaningful benefit, with high rates of durable responses. The overall response rate (ORR) was 95.5% (95% CI: 87.3-99.1; one-sided p<0.0001), with 62.1% of patients achieving a complete response (CR) (95% CI: 49.3-73.8; one-sided p<0.0001) by independent review committee per CT. With a median follow-up of 21.6, 23.8, and 24.5 months, respectively, the 24-month rates were 88.6% for duration of response, 85.7% for progression-free survival, and 90.4% for overall survival.
Liso-celexhibited a consistent safety profile, with low rates of severe cytokine release syndrome (CRS) and neurologic events (NE) with no new safety signals observed. Any grade CRS occurred in 76% of patients, with Grade 3 CRS occurring in 4% of patients and no Grade 4/5 CRS reported. Any grade NEs were reported in 33% of patients, with Grade 3 NEs occurring in 4% of patients and no Grade 4/5 NEs reported. The study will continue to evaluate ORR and safety in patients through the final analysis.
“MZL is an indolent disease but remains an area of high unmet need for patients who are relapsing and reaching later lines of treatment,” said Rosanna Ricafort, vice president, Senior Global Program Lead for Hematology and Cell Therapy, Bristol Myers Squibb. “We are proud to present for the first time the primary analysis data from the MZL cohort of TRANSCEND FL, underscoring our commitment to unlock the full potential of cell therapy to help patients living with relapsed or refractory lymphomas. As highlighted by the data at ICML, Breyanzi continues to cover the broadest patient eligibility of any CAR T for B-cell malignancies and demonstrates a safety profile consistent with clinical trials and in the real-world setting for approved indications.”
Additional key Bristol Myers Squibb data presentations on liso-celat ICML 2025 include:
Title: Lisocabtagene maraleucel in R/R FL (TRANSCEND FL): impact of prior lines of therapy, bendamustine exposure, and disease progression ≤24 months of initial systemic therapy
Oral presentation: Thursday, June 19
Key findings: Results support the sustained clinical benefit and safety profile of liso-cel for patients with R/R regardless of POD24 status and prior bendamustine exposure with a trend for better outcomes in earlier lines of therapy.
Title: Matching-adjusted indirect comparison of lisocabtagene maraleucel versus epcoritamab in patients with third-line or later relapsed or refractory follicular lymphoma
Poster session: Thursday, June 19
Key findings: The data support liso-cel as an effective treatment for patients with third-line plus R/R FL, potentially offering improved efficacy over epcoritamab in this setting.
Title: Comparative outcomes of lisocabtagene maraleucel (liso-cel) versus an external control arm (ECA) in third-line or later (3L+) R/R follicular lymphoma (FL)
Poster session: Friday, June 20
Key findings: Liso-cel appeared to show better efficacy than SOC therapies in patients with third-line plus R/R FL, further supporting it as an important treatment option to improve patient outcomes in this setting.
Title: Optimizing post–chimeric antigen receptor T cell monitoring: evidence across lisocabtagene maraleucel pivotal clinical trials and real-world experience (recently presented at the American Society of Clinical Oncology meeting)
Poster session: Friday, June 20
Key findings: Results showed that most cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome events in patients treated with liso-cel occurred less than 2 weeks after infusion and were not severe, providing insight into the onset of these events across clinical trials and in the real-world setting.
Bristol Myers Squibb thanks the patients and investigators involved in the clinical trials.
About TRANSCEND FL
TRANSCEND FL (NCT04245839) is an open-label, global, multicenter, Phase 2, single-arm study to determine the efficacy and safety of Breyanzi in patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma, including follicular lymphoma and marginal zone lymphoma. The primary outcome measure is overall response rate. Secondary outcome measures include complete response rate, duration of response, and progression-free survival.
About MZL
Marginal zone lymphoma (MZL) is the third most common lymphoma, accounting for about 7% of all non-Hodgkin lymphoma cases. Most patients with MZL are at a median age of 67 years when they are diagnosed. MZL develops when white blood cells cluster together to form lumps in a person’s lymph nodes or organs. Initial therapy often leads to remission, but relapse is common, sometimes occurring several times over many years. A small portion of MZL cases transform into diffuse large-B-cell lymphoma, a more aggressive lymphoma.
About Breyanzi
Breyanzi is a CD19-directed CAR T cell therapy with a 4-1BB costimulatory domain, which enhances the expansion and persistence of the CAR T cells. Breyanzi is made from a patient’s own T cells, which are collected and genetically reengineered to become CAR T cells that are then delivered via infusion as a one-time treatment.
Breyanzi is approved in the U.S. for the treatment of relapsed or refractory large B-cell lymphoma (LBCL) after at least one prior line of therapy, has received accelerated approval for the treatment of relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after at least two prior lines of therapy and relapsed or refractory follicular lymphoma (FL) in the third-line plus setting, and is approved for the treatment of relapsed or refractory mantle cell lymphoma in the third-line plus setting. Breyanzi is also approved in Japan, the European Union (EU), Switzerland, the United Kingdom and Canada for the treatment of relapsed or refractory LBCL after at least one prior line of therapy; in Japan for the treatment of patients with relapsed or refractory high-risk FL after one prior line of systemic therapy and in patients with relapsed or refractory FL after two or more lines of systemic therapy; and in the EU for the treatment of relapsed or refractory FL after two or more lines of systemic therapy.
Bristol Myers Squibb’s clinical development program for Breyanzi includes clinical studies in several types of lymphoma. For more information, visit clinicaltrials.gov.
U.S. FDA-Approved Indications
BREYANZI is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:
- adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have:
- refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or
- refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age; or
- relapsed or refractory disease after two or more lines of systemic therapy.
Limitations of Use: BREYANZI is not indicated for the treatment of patients with primary central nervous system lymphoma.
- adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least 2 prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
- adult patients with relapsed or refractory follicular lymphoma (FL) who have received 2 or more prior lines of systemic therapy. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
- adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least 2 prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor.
Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide.
Bristol Myers Squibb: Unlocking the Full Potential of Cell Therapy
A pioneer in harnessing the immune system to fight cancer and an established leader in cell therapy, Bristol Myers Squibb is uniquely positioned to unlock the full potential of this technology across blood cancers and within new frontiers, including autoimmune disease.
Bristol Myers Squibb is currently the only company with two approved CAR T cell therapies with two distinct targets, available in major markets around the world. Our bold vision for the future is one in which hundreds of thousands of patients can be treated with cell therapy’s transformational potential.
The building blocks to realize this ambition—a promising and differentiated pipeline, extensive translational and clinical data sets, a deep bench of talent, and robust manufacturing capabilities— are in our cells. We are laser-focused on advancing the field of cell therapy toward a true revolution for patients. Learn more about the science behind cell therapy and ongoing progress at Bristol Myers Squibb here.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, X, YouTube, Facebook and Instagram.
SOURCE: Bristol Myers Squibb
Post Views: 1,800
95.5% of patients with relapsed or refractory marginal zone lymphoma (MZL) treated with lisocabtagene maraleucel (liso-cel) achieved a response, with 62.1% achieving complete response and 88.6% maintaining a response at 24 months
New data show liso-cel demonstrated high rates of durable responses and a consistent safety profile in a fifth cancer type, the most of any CD19-directed CAR T cell therapy
Additional liso-cel data at ICML 2025 further reinforce BMS’ commitment to unlocking the full potential of this therapy for patients
PRINCETON, NJ, USA I June 16, 2025 I Bristol Myers Squibb (NYSE: BMY) today announced the first disclosure of the primary analysis results of the marginal zone lymphoma (MZL) cohort of TRANSCEND FL, an open-label, global, multicenter, Phase 2, single-arm study evaluating Breyanzi (lisocabtagene maraleucel; liso-cel) in patients with relapsed or refractory disease. The new data will be presented at the 2025 International Conference on Malignant Lymphoma (ICML) in an oral presentation on June 19, building on positive topline results announced in February.
$BMY to present data highlighting #CARTcelltherapy advances for patients with relapsed or refractory blood cancers at #18ICML.
Share
“Liso-cel achieved high, lasting response rates in patients with relapsed or refractory marginal zone lymphoma, underscoring the potential of this one-time therapy to significantly improve patient outcomes,” said M. Lia Palomba, M.D., TRANSCEND FL study investigator and lymphoma and cell therapy specialist, Memorial Sloan Kettering Cancer Center. “Currently, the median survival for patients with marginal zone lymphoma with multiple relapses is 3 to 5 years, signifying an urgent need for transformative therapies that can effectively address this hard-to-treat disease.”
The MZL cohort of TRANSCEND FL enrolled adults with relapsed or refractory disease treated with liso-cel in the third-line plus setting. Patients received treatment with liso-cel at a target dose of 100 x 106 CAR-positive viable T cells.
In efficacy-evaluable patients with relapsed or refractory MZL treated with liso-cel (n=66), liso-cel demonstrated clinically meaningful benefit, with high rates of durable responses. The overall response rate (ORR) was 95.5% (95% CI: 87.3-99.1; one-sided p<0.0001), with 62.1% of patients achieving a complete response (CR) (95% CI: 49.3-73.8; one-sided p<0.0001) by independent review committee per CT. With a median follow-up of 21.6, 23.8, and 24.5 months, respectively, the 24-month rates were 88.6% for duration of response, 85.7% for progression-free survival, and 90.4% for overall survival.
Liso-celexhibited a consistent safety profile, with low rates of severe cytokine release syndrome (CRS) and neurologic events (NE) with no new safety signals observed. Any grade CRS occurred in 76% of patients, with Grade 3 CRS occurring in 4% of patients and no Grade 4/5 CRS reported. Any grade NEs were reported in 33% of patients, with Grade 3 NEs occurring in 4% of patients and no Grade 4/5 NEs reported. The study will continue to evaluate ORR and safety in patients through the final analysis.
“MZL is an indolent disease but remains an area of high unmet need for patients who are relapsing and reaching later lines of treatment,” said Rosanna Ricafort, vice president, Senior Global Program Lead for Hematology and Cell Therapy, Bristol Myers Squibb. “We are proud to present for the first time the primary analysis data from the MZL cohort of TRANSCEND FL, underscoring our commitment to unlock the full potential of cell therapy to help patients living with relapsed or refractory lymphomas. As highlighted by the data at ICML, Breyanzi continues to cover the broadest patient eligibility of any CAR T for B-cell malignancies and demonstrates a safety profile consistent with clinical trials and in the real-world setting for approved indications.”
Additional key Bristol Myers Squibb data presentations on liso-celat ICML 2025 include:
Title: Lisocabtagene maraleucel in R/R FL (TRANSCEND FL): impact of prior lines of therapy, bendamustine exposure, and disease progression ≤24 months of initial systemic therapy
Oral presentation: Thursday, June 19
Key findings: Results support the sustained clinical benefit and safety profile of liso-cel for patients with R/R regardless of POD24 status and prior bendamustine exposure with a trend for better outcomes in earlier lines of therapy.
Title: Matching-adjusted indirect comparison of lisocabtagene maraleucel versus epcoritamab in patients with third-line or later relapsed or refractory follicular lymphoma
Poster session: Thursday, June 19
Key findings: The data support liso-cel as an effective treatment for patients with third-line plus R/R FL, potentially offering improved efficacy over epcoritamab in this setting.
Title: Comparative outcomes of lisocabtagene maraleucel (liso-cel) versus an external control arm (ECA) in third-line or later (3L+) R/R follicular lymphoma (FL)
Poster session: Friday, June 20
Key findings: Liso-cel appeared to show better efficacy than SOC therapies in patients with third-line plus R/R FL, further supporting it as an important treatment option to improve patient outcomes in this setting.
Title: Optimizing post–chimeric antigen receptor T cell monitoring: evidence across lisocabtagene maraleucel pivotal clinical trials and real-world experience (recently presented at the American Society of Clinical Oncology meeting)
Poster session: Friday, June 20
Key findings: Results showed that most cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome events in patients treated with liso-cel occurred less than 2 weeks after infusion and were not severe, providing insight into the onset of these events across clinical trials and in the real-world setting.
Bristol Myers Squibb thanks the patients and investigators involved in the clinical trials.
About TRANSCEND FL
TRANSCEND FL (NCT04245839) is an open-label, global, multicenter, Phase 2, single-arm study to determine the efficacy and safety of Breyanzi in patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma, including follicular lymphoma and marginal zone lymphoma. The primary outcome measure is overall response rate. Secondary outcome measures include complete response rate, duration of response, and progression-free survival.
About MZL
Marginal zone lymphoma (MZL) is the third most common lymphoma, accounting for about 7% of all non-Hodgkin lymphoma cases. Most patients with MZL are at a median age of 67 years when they are diagnosed. MZL develops when white blood cells cluster together to form lumps in a person’s lymph nodes or organs. Initial therapy often leads to remission, but relapse is common, sometimes occurring several times over many years. A small portion of MZL cases transform into diffuse large-B-cell lymphoma, a more aggressive lymphoma.
About Breyanzi
Breyanzi is a CD19-directed CAR T cell therapy with a 4-1BB costimulatory domain, which enhances the expansion and persistence of the CAR T cells. Breyanzi is made from a patient’s own T cells, which are collected and genetically reengineered to become CAR T cells that are then delivered via infusion as a one-time treatment.
Breyanzi is approved in the U.S. for the treatment of relapsed or refractory large B-cell lymphoma (LBCL) after at least one prior line of therapy, has received accelerated approval for the treatment of relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after at least two prior lines of therapy and relapsed or refractory follicular lymphoma (FL) in the third-line plus setting, and is approved for the treatment of relapsed or refractory mantle cell lymphoma in the third-line plus setting. Breyanzi is also approved in Japan, the European Union (EU), Switzerland, the United Kingdom and Canada for the treatment of relapsed or refractory LBCL after at least one prior line of therapy; in Japan for the treatment of patients with relapsed or refractory high-risk FL after one prior line of systemic therapy and in patients with relapsed or refractory FL after two or more lines of systemic therapy; and in the EU for the treatment of relapsed or refractory FL after two or more lines of systemic therapy.
Bristol Myers Squibb’s clinical development program for Breyanzi includes clinical studies in several types of lymphoma. For more information, visit clinicaltrials.gov.
U.S. FDA-Approved Indications
BREYANZI is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:
- adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have:
- refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or
- refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age; or
- relapsed or refractory disease after two or more lines of systemic therapy.
Limitations of Use: BREYANZI is not indicated for the treatment of patients with primary central nervous system lymphoma.
- adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least 2 prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
- adult patients with relapsed or refractory follicular lymphoma (FL) who have received 2 or more prior lines of systemic therapy. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
- adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least 2 prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor.
Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide.
Bristol Myers Squibb: Unlocking the Full Potential of Cell Therapy
A pioneer in harnessing the immune system to fight cancer and an established leader in cell therapy, Bristol Myers Squibb is uniquely positioned to unlock the full potential of this technology across blood cancers and within new frontiers, including autoimmune disease.
Bristol Myers Squibb is currently the only company with two approved CAR T cell therapies with two distinct targets, available in major markets around the world. Our bold vision for the future is one in which hundreds of thousands of patients can be treated with cell therapy’s transformational potential.
The building blocks to realize this ambition—a promising and differentiated pipeline, extensive translational and clinical data sets, a deep bench of talent, and robust manufacturing capabilities— are in our cells. We are laser-focused on advancing the field of cell therapy toward a true revolution for patients. Learn more about the science behind cell therapy and ongoing progress at Bristol Myers Squibb here.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, X, YouTube, Facebook and Instagram.
SOURCE: Bristol Myers Squibb
Post Views: 1,800
