A Phase 2, multicenter, single-arm trial

Make Breyanzi® THE ONE to deliver deep and durable responses after a one-time infusion* in 3L+ FL1

TRANSCEND FL evaluated Breyanzi in adult patients with R/R FL after 2 or more lines of systemic therapy.1

Primary endpoint: ORR1

Select secondary endpoints: CR, DOR, PFS, and safety2

Patients were allowed to receive bridging therapy.1

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

96% of patients achieved a response, with 73% achieving a complete response1

Response rates in the TRANSCEND FL trial (N=94)

Response per IRC, FDA criteria1*

Graph of Breyanzi 3L+ follicular lymphoma response rates in the TRANSCEND FL trial: 96% ORR, 73% CR, and 22% PR.

*ORR was evaluated per the Lugano criteria and is defined as the percentage of patients achieving a best overall response of either a PR or CR, as assessed by an IRC. CR required a negative bone marrow biopsy after treatment in patients who did not have a negative bone marrow biopsy between their most recent disease progression and prior to initiation of lymphodepleting chemotherapy.1

Deep and durable responses1

Duration of response in the TRANSCEND FL trial (90/94)1,3

Graph of Breyanzi 3L+ FL duration of response in the TRANSCEND FL clinical trial. 77% DOR at 18 months, Median DOR was not reached.

Most patients continued to respond for the duration of the follow-up period after a
one-time infusion1†

*Based on Kaplan-Meier estimates.1

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

3L, third-line; CI, confidence interval; CR, complete response; DOR, duration of response; FL, follicular lymphoma; IRC, Independent Review Committee; NR, not reached; ORR, overall response rate; PFS, progression-free survival; PR, partial response; R/R, relapsed or refractory.

74% of patients survived with no sign of disease progression at 18 months3

PFS in the TRANSCEND FL trial (N=94)3

Graph of Breyanzi 3L+ follicular lymphoma progression-free survival rates in the TRANSCEND FL clinical trial. 74% PFS at 18 months. Median PFS not reached.

mPFS not reached (95% Cl: 18.96, NR)3

Analysis limitations:

  • PFS data are not in the Prescribing Information and should be interpreted with caution
  • PFS was a secondary endpoint in TRANSCEND FL 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 PFS is not known

*Based on Kaplan-Meier estimates.3

3L, third-line; CI, confidence interval; CR, complete response; DOR, duration of response; FL, follicular lymphoma; mPFS, median progression-free survival; NR, not reached; ORR, overall response rate; PFS, progression-free survival; R/R, relapsed or refractory.

A PHASE 2, OPEN-LABEL, MULTICENTER, SINGLE-ARM TRIAL1

Giving patients with R/R FL a chance to benefit with Breyanzi1

Hypothetical Breyanzi 3L FL patients

Screening1,3

Broad eligibility in TRANSCEND FL:

  • Adult patients with R/R FL Grade 1, 2, or 3A; with or without high-risk disease who have received 2 or more prior lines of systemic therapy (including an anti-CD20 antibody and an alkylating agent)
  • ECOG PS 0-1
  • LVEF ≥40%
  • CrCl >30 mL/min
  • ALT ≤5x ULN
  • Wide range of prior therapies (range: 2-10)
  • Received combination of anti-CD20 antibody and alkylator*
  • No upper age limit (studied across a broad age range: 23-80 years)
  • With or without high-risk markers (eg, POD24, GELF ≥1, double refractory)
CAR T-cells manufacturing

Breyanzi manufacturing1

Bridging chemotherapy was permitted between leukapheresis and lymphodepleting chemotherapy

CAR T-cells infusion bag

Lymphodepletion1†

FLU 30 mg/m2 and CY 300 mg/m2 × 3 days

Infusion

Breyanzi infusion1

2 to 7 days after FLU/CY, planned dose of 100 × 106 CAR+ T cells

  • Primary endpoints: ORR1‡
  • Select secondary endpoints: CR, DOR, PFS, and safety2

Of 114 patients who underwent leukapheresis, 107 received Breyanzi and the median dose administered was 100.02 x 106 CAR-positive viable T cells (range: 93.4 to 109.2 x 106 CAR-positive viable T cells).1

The primary efficacy analysis included 94 patients who had PET-positive disease at study baseline or confirmation of PET-positive disease after bridging therapy, received conforming product in intended dose range, and had at least 9 months of follow-up from the date of first response.1

*65% of patients are double refractory to any line of therapy of an anti-CD20 antibody and alkylator.3

†Measurable disease reconfirmed prior to lymphodepletion.2

‡Best overall response of complete response or partial response, per IRC using Lugano 2014 criteria.1

Studied in patients you are likely to see in your practice

TRANSCEND FL Cohort trial design (N=94)1,3

Breyanzi was assessed in a Phase 2, open-label, multicenter, single-arm trial of adult patients with R/R FL Grade 1, 2, or 3A after 2 or more lines of systemic therapy (including an anti-CD20 antibody and an alkylating agent). Of 114 patients who underwent leukapheresis, 107 received Breyanzi, and of these, 94 were evaluable for efficacy. The primary endpoint was ORR. Key secondary endpoints included CR, DOR, PFS, and safety. Patients were required to have an ECOG PS ≤1 and adequate bone marrow, kidney, liver, and cardiac function. Bridging therapy prior to receiving Breyanzi was permitted between leukapheresis and start of lymphodepleting chemotherapy.

Age1  
Median age, years (range) 62 (23-80)
Male 62%
Prior therapies1
HSCT 29%
Rituximab and lenalidomide 20%
FLIPI at screening3
High risk (3-5) 61%
Intermediate risk (2) 29%
Low risk (0-1) 11%
Patients with Stage III-IV disease1 89%
Previous treatment response/high-risk features1,3
Refractory to last systemic therapy 34%
Double refractory (anti-CD20 and alkylator) 65%
POD24 50%
GELF ≥1 51%
  • The median number of prior systemic therapies was 3 (range: 2 to 10), with 46% receiving 2 prior lines, 22% receiving 3 prior lines, and 32% receiving ≥4 prior lines1
  • In the trial, 40% of patients received bridging therapy1

Median time from completion of most recent treatment to relapse was 2 months3*†

*Median time to progression or stable disease if missing progression data is based on N=94.3

†Median time from FL diagnosis to Breyanzi infusion was 5.1 years.3

3L, third-line; ALT, alanine aminotransferase; CAR, chimeric antigen receptor; CR, complete response; CrCl, creatinine clearance; CY, cyclophosphamide; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; FL, follicular lymphoma; FLIPI, Follicular Lymphoma International Prognostic Index; FLU, fludarabine; GELF, Groupe d’Etude des Lymphomes Folliculaires criteria; HSCT, hematopoietic stem cell transplantation; IRC, Independent Review Committee; LVEF, left ventricular ejection fraction; ORR, overall response rate; PET, positron emission tomography; PFS, progression-free survival; POD24, disease progression within 24 months of diagnosis; R/R, relapsed or refractory; ULN, upper limit of normal.

References

  1. Breyanzi [package insert]. Summit, NJ: Bristol-Myers Squibb Company; 2025.
  2. Data on file. BMS-REF-LIS-0045. Princeton, NJ: Bristol-Myers Squibb Company; 2024.
  3. Data on file. BMS-REF-LIS-0050. Princeton, NJ: Bristol-Myers Squibb Company; 2024.

Important Safety Information

Indication

BREYANZI is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:

  • 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).

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 (incidence ≥30%) in FL is cytokine release syndrome. The most common Grade 3-4 laboratory abnormalities include lymphocyte count decrease, neutrophil count decrease, and white blood cell decrease.

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

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2009-US-2500223

09/2025