An open-label, single-arm trial (N=268)

TRANSCEND trial: Largest pivotal trial in 3L+ LBCL, including patients with high-risk disease1,2

Primary endpoints: ORR and safety2

Select secondary endpoints: CR, DOR, and OS2

Bridging therapy prior to receiving Breyanzi® was optional.1

Breyanzi is THE ONE to deliver deep and durable complete response in a one-time infusion, with more than 50% of patients achieving CR1*

Response rates (N=192)1

Graph depicting response rates in TRANSCEND clinical trial for 3L+ LBCL

The IRC-assessed overall response rate in the leukapheresed population (N=287) was 59% (95% CI: 53, 64), with a CR rate of 43% (95% CI: 37, 49) and PR rate of 15% (95% CI: 11, 20).1†

Efficacy was established on the basis of CR rate and DOR, as determined by an IRC per the Lugano 2014 criteria.1

DOR rates1

Number of responders
(141/192)		 Median months (95% Cl)
DOR 16.7 (5.3, NR),‡ range§: 0.0±23.5+
DOR if best
response is CR		 NR (16.7, NR),‡ range§: 0.7±23.5+
DOR if best
response is PR		 1.4 (1.1, 2.2),‡ range§: 0.0±22.8+

1-month median time to first CR (range: 0.8-12.5 months)1

DOR by best overall response; median DOR: 16.7 months1,3

Graph showing DOR in Breyanzi TRANSCEND trial

Of the 104 patients who achieved CR, 68 (65%) had remission lasting at least
6 months, and 64 (62%) had remission lasting at least 9 months1

Median DOR for PR: 1.4 months (95% CI: 1.1, 2.2).1

*Treatment process includes leukapheresis, manufacturing, administration, and adverse event monitoring.1

†Of the 287 patients who underwent leukapheresis and had radiographically evaluable disease, 27 additional patients achieved a response, apart from the responses noted in graph above. These efficacy results include responses that may have been contributed solely by bridging therapy or product outside of the intended dose range or out of specification.1

‡Kaplan-Meier method was used to obtain 2-sided 95% confidence intervals.1

§A plus sign (+) indicates a censored value.1

3L, third-line; CI, confidence interval; CR, complete response; DOR, duration of response; IRC, Independent Review Committee; LBCL, large B-cell lymphoma; NR, not reached; ORR, overall response rate; OS, overall survival; PR, partial response.

Overall survival at 2-year follow-up

mOS: 27.3 months (95% CI: 16.2, 45.6)4

Median follow-up: 29.3 months (95% CI: 26.2, 30.4)4*

Overall survival at 2 year follow up Breyanzi TRANSCEND clinical trial

51% of all patients were alive at 2 years4

Analysis limitations:

  • OS data are not in the Prescribing Information and should be interpreted with caution
  • OS was a secondary endpoint in TRANSCEND and was not statistically tested in the setting of a single-arm trial. It is not possible to determine if the observed effect is attributable to Breyanzi or to the natural history of the disease2
  • The statistical significance of OS is not known

*Reverse Kaplan-Meier method was used to calculate median (95% CI) of follow-up.4

3L, third-line; CI, confidence interval; CR, complete response; DOR, duration of response; LBCL, large B-cell lymphoma; mOS, median overall survival; N/R, nonresponder; ORR, overall response rate; OS, overall survival; PR, partial response.

TRANSCEND trial1,2

Trial design of Breyanzi TRANSCEND clinical trial 

The trial included both patients who had previous stem cell transplants and patients who did not undergo transplant due to ineligibility or other reasons. There was no prespecified threshold for blood counts; patients were eligible to enroll if they were assessed to have adequate bone marrow function to receive LDC.1

  • Primary endpoints: ORR and safety2
  • Select secondary endpoints: CR, DOR, and OS2

TRANSCEND trial design and patient disposition1

Of 299 patients who underwent leukapheresis:

  • 44 (15%) did not receive CAR-positive T cells either due to manufacturing failures (2/44), death (29/44), disease complications (6/44), or other reasons (7/44)
  • 204 (68%) received Breyanzi in the intended dose range, of whom 192 were evaluable for efficacy (main efficacy population); 12 were not evaluable due to absence of PET-positive disease at study baseline or after bridging therapy
  • 51 (17%) either received Breyanzi outside of the intended dose range (26/51) or received CAR‑positive T cells that did not meet the product specifications for Breyanzi (manufacturing failures [25/51])

Patients were allowed to receive bridging therapy prior to receiving Breyanzi. Optional bridging therapy for disease control included intrathecal chemotherapy or radiation therapy for treatment of CNS lymphoma.1

25 patients were treated in an outpatient setting per physicians’ discretion2

Breyanzi: THE ONE studied in patients you are likely to see in your practice1,2

Characteristics (N=268)
Median age, years (range) 63 (18-86)
≥65 years/≥75 years 42%/10%
Large B-cell lymphoma subtype, n (%)  
DLBCL, NOS 53%
DLBCL transformed from indolent lymphoma 25%
High-grade B-cell lymphoma 14%
Primary mediastinal
large B-cell lymphoma		 7%
Follicular lymphoma,
Grade 3B		 1%

3L, third-line; CAR, chimeric antigen receptor; CNS, central nervous system; CR, complete response; CY, cyclophosphamide; DLBCL, diffuse large B-cell lymphoma; DOR, duration of response; FLU, fludarabine; LBCL, large B-cell lymphoma; LDC, lymphodepleting chemotherapy; NOS, not otherwise specified; ORR, objective response rate; OS, overall survival; PET, positron emission tomography.

References

  1. Breyanzi [package insert]. Summit, NJ: Bristol-Myers Squibb Company; 2025.
  2. Abramson JS, Palomba ML, Gordon LI, et al. Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphomas (TRANSCEND NHL 001): a multicentre seamless design study. Lancet. 2020;396(10254):839-852.
  3. Data on file. BMS-REF-LIS-0052. Princeton, NJ: Bristol-Myers Squibb Company; 2024.
  4. Abramson JS, Palomba ML, Gordon LI, et al. Two-year follow-up of lisocabtagene maraleucel in relapsed or refractory large B-cell lymphoma in TRANSCEND NHL 001. Blood. 2024;143(5):404-416.

Important Safety Information

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.

Important Safety Information

WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, AND SECONDARY HEMATOLOGICAL MALIGNANCIES

  • Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving BREYANZI. Do not administer BREYANZI to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab with or without corticosteroids.
  • Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving BREYANZI, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with BREYANZI. Provide supportive care and/or corticosteroids as needed.
  • T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including BREYANZI.

Cytokine Release Syndrome

Cytokine release syndrome (CRS), including fatal or life-threatening reactions, occurred following treatment with BREYANZI. In clinical trials of BREYANZI, which enrolled a total of 702 patients with non-Hodgkin lymphoma (NHL), CRS occurred in 54% of patients, including ≥ Grade 3 CRS in 3.2% of patients. The median time to onset was 5 days (range: 1 to 63 days). CRS resolved in 98% of patients with a median duration of 5 days (range: 1 to 37 days). One patient had fatal CRS and 5 patients had ongoing CRS at the time of death. The most common manifestations of CRS (≥10%) were fever, hypotension, tachycardia, chills, hypoxia, and headache.

Serious events that may be associated with CRS include cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), cardiac arrest, cardiac failure, diffuse alveolar damage, renal insufficiency, capillary leak syndrome, hypotension, hypoxia, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS).

Ensure that 2 doses of tocilizumab are available prior to infusion of BREYANZI.

Neurologic Toxicities

Neurologic toxicities that were fatal or life-threatening, including immune effector cell-associated neurotoxicity syndrome (ICANS), occurred following treatment with BREYANZI. Serious events including cerebral edema and seizures occurred with BREYANZI. Fatal and serious cases of leukoencephalopathy, some attributable to fludarabine, also occurred.

In clinical trials of BREYANZI, CAR T cell-associated neurologic toxicities occurred in 31% of patients, including ≥ Grade 3 cases in 10% of patients. The median time to onset of neurotoxicity was 8 days (range: 1 to 63 days). Neurologic toxicities resolved in 88% of patients with a median duration of 7 days (range: 1 to 119 days). Of patients developing neurotoxicity, 82% also developed CRS.

The most common neurologic toxicities (≥5%) included encephalopathy, tremor, aphasia, headache, dizziness, and delirium.

CRS and Neurologic Toxicities Monitoring

Monitor patients daily for at least 7 days following BREYANZI infusion for signs and symptoms of CRS and neurologic toxicities and assess for other causes of neurological symptoms. Continue to monitor patients for signs and symptoms of CRS and neurologic toxicities for at least 2 weeks after infusion and treat promptly. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated. Manage neurologic toxicity with supportive care and/or corticosteroid as needed. Advise patients to avoid driving for at least 2 weeks following infusion. Counsel patients to seek immediate medical attention should signs or symptoms of CRS or neurologic toxicity occur at any time.

Hypersensitivity Reactions

Allergic reactions may occur with the infusion of BREYANZI. Serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide (DMSO).

Serious Infections

Severe infections, including life-threatening or fatal infections, have occurred in patients after BREYANZI infusion. In clinical trials of BREYANZI, infections of any grade occurred in 34% of patients, with Grade 3 or higher infections occurring in 12% of all patients. Grade 3 or higher infections with an unspecified pathogen occurred in 7%, bacterial infections in 3.7%, viral infections in 2%, and fungal infections in 0.7% of patients. One patient who received 4 prior lines of therapy developed a fatal case of John Cunningham (JC) virus progressive multifocal leukoencephalopathy 4 months after treatment with BREYANZI. One patient who received 3 prior lines of therapy developed a fatal case of cryptococcal meningoencephalitis 35 days after treatment with BREYANZI.

Febrile neutropenia developed after BREYANZI infusion in 8% of patients. Febrile neutropenia may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated.

Monitor patients for signs and symptoms of infection before and after BREYANZI administration and treat appropriately. Administer prophylactic antimicrobials according to standard institutional guidelines. Avoid administration of BREYANZI in patients with clinically significant, active systemic infections.

Viral reactivation: Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells. In clinical trials of BREYANZI, 35 of 38 patients with a prior history of HBV were treated with concurrent antiviral suppressive therapy. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing. In patients with prior history of HBV, consider concurrent antiviral suppressive therapy to prevent HBV reactivation per standard guidelines.

Prolonged Cytopenias

Patients may exhibit cytopenias not resolved for several weeks following lymphodepleting chemotherapy and BREYANZI infusion. In clinical trials of BREYANZI, Grade 3 or higher cytopenias persisted at Day 29 following BREYANZI infusion in 35% of patients, and included thrombocytopenia in 25%, neutropenia in 22%, and anemia in 6% of patients. Monitor complete blood counts prior to and after BREYANZI administration.

Hypogammaglobulinemia

B-cell aplasia and hypogammaglobulinemia can occur in patients receiving BREYANZI. In clinical trials of BREYANZI, hypogammaglobulinemia was reported as an adverse reaction in 10% of patients. Hypogammaglobulinemia, either as an adverse reaction or laboratory IgG level below 500 mg/dL after infusion, was reported in 30% of patients. Monitor immunoglobulin levels after treatment with BREYANZI and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement as clinically indicated.

Live vaccines: The safety of immunization with live viral vaccines during or following BREYANZI treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during BREYANZI treatment, and until immune recovery following treatment with BREYANZI.

Secondary Malignancies

Patients treated with BREYANZI may develop secondary malignancies. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including BREYANZI. Mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes. Monitor lifelong for secondary malignancies. In the event that a secondary malignancy occurs, contact Bristol-Myers Squibb at 1-888-805-4555 for reporting and to obtain instructions on collection of patient samples for testing.

Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome (IEC-HS)

Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome (IEC-HS), including fatal or life-threatening reactions, occurred following treatment with BREYANZI. IEC-HS is a life-threatening condition with a high mortality rate if not recognized and treated early. Treatment of IEC-HS should be administered per current practice guidelines.

Adverse Reactions

The most common adverse reaction(s) (incidence ≥30%) in:

  • LBCL are fever, cytokine release syndrome, fatigue, musculoskeletal pain, and nausea. The most common Grade 3-4 laboratory abnormalities include lymphocyte count decrease, neutrophil count decrease, platelet count decrease, and hemoglobin decrease.

Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide.

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2009-US-2500226

09/2025