As demonstrated in TRANSCEND FL: a Phase 2, multicenter, single-arm trial1

Breyanzi® provided outstanding responses and durable outcomes in a broad range of patients1

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, safety2
Patients were allowed to receive bridging therapy

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

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

Breyanzi 2L+ response rates at 18 months per IRC,FDA criteria in the TRANSCEND FL trial, graph Breyanzi 2L+ response rates at 18 months per IRC,FDA criteria in the TRANSCEND FL trial, graph

Median follow-up: 17 months3

*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

†ORR and CR were evaluated per the Lugano criteria, as assessed by an IRC.1 Data are not in the Prescribing Information and should be carefully interpreted.1

Deep and durable outcomes1

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

Breyanzi 2L+ duration of response in the TRANSCEND FL clinical trial, graph Breyanzi 2L+ duration of response in the TRANSCEND FL clinical trial, graph

Number of subjects at risk (censored patients)

Months 3L+ FL
0 90 (0)
3 84 (0)
6 77 (0)
9 76 (0)
12 61 (12)
15 48 (12)
18 8 (39)
21 7 (0)
24 0 (7)

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

*Based on KM estimates.3

†Treatment process can take approximately 2 to 3 months and 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 (90/94)3

Breyani progression free survival (PFS) in the TRANSCEND FL clinical trial, graph Breyani progression free survival (PFS) in the TRANSCEND FL clinical trial, graph

Number of subjects at risk (censored patients)

Months 3L+ FL
0 94 (0)
3 89 (0)
6 82 (0)
9 77 (0)
12 71 (3)
15 49 (20)
18 18 (30)
21 7 (10)
24 2 (5)
27 0 (2)

PFS was a secondary endpoint in the TRANSCEND FL study and was not statistically tested in the setting of a single-arm trial. PFS data are not in the Prescribing Information and should be interpreted with caution.

*Based on KM 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

Breyani trial design, graph Breyani trial design, graph
  • Primary endpoint: ORR1‡
  • Select secondary endpoints: CR, PFS, DOR, 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).

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.3

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

Studied in patients you are likely to see in your practice1,3

Age1
Median age, range 63 (23-80)
Male 62%
Prior therapies3
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 disease 89%
Previous treatment response/high-risk features3
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

ALT, alanine transaminase; CAR, chimeric antigen receptor; CrCl, creatinine clearance; CR, complete response; CY, cyclophosphamide; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; FL, follicular lymphoma; FLU, fludarabine; GELF, Groupe d’Etude des Lymphomes Folliculaires criteria; HSCT, hematopoietic stem cell transplantation; 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.

Important Safety Information
LESS
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.
  • BREYANZI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the BREYANZI REMS.
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 614 patients with non-Hodgkin lymphoma (NHL), CRS occurred in 53% of patients, including Grade 3 or higher CRS in 4% of patients. The median time to onset was 5 days (range: 1 to 63 days). CRS resolved in 98% of patients with median duration of 5 days (range: 1 to 37 days). 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 87% of patients with a median duration of 8 days (range: 1 to 119 days). Of patients developing neurotoxicity, 81% 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 at a REMS-certified healthcare facility for signs and symptoms of CRS and neurologic toxicities and assess for other causes of neurological symptoms. Monitor patients for signs and symptoms of CRS and neurologic toxicities for at least 4 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. Counsel patients to seek immediate medical attention should signs or symptoms of CRS or neurologic toxicity occur at any time.
BREYANZI REMS
Because of the risk of CRS and neurologic toxicities, BREYANZI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the BREYANZI REMS. The required components of the BREYANZI REMS are:
  • Healthcare facilities that dispense and administer BREYANZI must be enrolled and comply with the REMS requirements.
  • Certified healthcare facilities must have on-site, immediate access to tocilizumab.
  • Ensure that a minimum of 2 doses of tocilizumab are available for each patient for infusion within 2 hours after BREYANZI infusion, if needed for treatment of CRS.
Further information is available at www.BreyanziREMS.com, or contact Bristol-Myers Squibb at 1-866-340-7332.
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 33% 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 4%, viral infections in 2%, and fungal infections in 0.7% of patients. One patient who received four prior lines of therapy developed a fatal case of John Cunningham (JC) virus progressive multifocal leukoencephalopathy four months 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, 26 of 29 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 34% of patients, and included thrombocytopenia in 24%, neutropenia in 22%, and anemia in 7% 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 29% 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.
Effects on Ability to Drive and Use Machines
Due to the potential for neurologic events, including altered mental status or seizures, patients receiving BREYANZI are at risk for developing altered or decreased consciousness or impaired coordination in the 8 weeks following BREYANZI administration. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, for at least 8 weeks.
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 reactions (incidence ≥30%) in FL are cytokine release syndrome. The most common Grade 3-4 laboratory abnormalities include lymphocyte count decreased, neutrophil count decreased, and white blood cell decrease.
Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide.
References
  1. Breyanzi [package insert]. Summit, NJ: Bristol-Myers Squibb Company; 2024.
  2. Data on file. REF-00871-2009. Princeton, NJ: Bristol-Myers Squibb Company; 2024.
  3. Data on file. BMS-REF-LIS-0050. Princeton, NJ: Bristol-Myers Squibb Company; 2024.

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References
  1. Breyanzi [package insert]. Summit, NJ: Bristol-Myers Squibb Company; 2024.
  2. Data on file. REF-00871-2009. Princeton, NJ: Bristol-Myers Squibb Company; 2024.
  3. Data on file. BMS-REF-LIS-0050. Princeton, NJ: Bristol-Myers Squibb Company; 2024.