An open-label, multicenter, single-arm trial1

TRANSCEND MCL Cohort evaluated Breyanzi® in adult patients with R/R MCL who have received at least 2 prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor1

Primary endpoints: ORR by IRC, safety1,2
Select secondary endpoints: CR, DOR, PFS, OS2
Bridging chemotherapy was permitted between leukapheresis and lymphodepleting chemotherapy1

Breyanzi provides deep responses in a one-time infusion1*

Response rates (N=68)†

Breyani response rates for R/R MCL in TRANSCEND MCL Cohort, graph Breyani response rates for R/R MCL in TRANSCEND MCL Cohort, graph

Response across select high-risk subgroups1

Overall response rates by mutational or proliferative status (subgroup analysis)3

Analysis limitations

  • These analyses are exploratory in nature, and definitive conclusions should not be drawn
  • Numbers may not be available in the Prescribing Information
Breyanzi response rates across high-risk subgroups, graphic Breyanzi response rates across high-risk subgroups, graphic

Overall response rates by prespecified subgroups3†

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Power to deliver durable response in R/R MCL1,3

Duration of response in TRANSCEND MCL Cohort (58/68)1,3§

Median follow-up: 22.2 months (95% CI: 16.7, 22.8)

Breyanzi duration of response in R/R MCL in TRANSCEND MCL Cohort, graph Breyanzi duration of response in R/R MCL in TRANSCEND MCL Cohort, graph

Months CR PR All Responders
0 60 9 69
3 50 0 50
6 42 42
9 35 35
12 28 28
15 27 27
18 18 18
21 18 18
24 1 1
27 0 0

1-month median time to first response (range: 0.7-3 months)1

Learn more about the efficacy and safety of Breyanzi.

*Treatment process can take approximately 2 to 3 months and includes leukapheresis, manufacturing, administration, and adverse event monitoring.1

†Per the 2014 Lugano classification (including bone marrow biopsy assessments), as assessed by IRC. ORR was defined as the percentage of patients with BOR of either CR or PR after Breyanzi infusion, as determined by IRC using 2014 Lugano classification.1

‡2-sided 95% exact Clopper-Pearson CIs.1

§Kaplan-Meier method was used to obtain 2-sided 95% CIs.3

BOR, best overall response; BTKi, Bruton tyrosine kinase inhibitor; CI, confidence interval; CNS, central nervous system; CR, compete response; DOR, duration of response; HSCT, hematopoietic stem cell transplantation; IRC, Independent Review Committee; LDH, lactate dehydrogenase; MCL, mantle cell lymphoma; mDoCR, median duration of complete response; mDoPR, median duration of partial response; mDOR, median duration of response; NR, not reached; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; PR, partial response; R/R, relapsed or refractory; sMIPI, simplified prognostic index for advanced-stage mantle cell lymphoma; SPD, sum of the products of the longest perpendicular diameters; TP53, tumor protein 53; U/L, units per liter; ULN, upper limit of normal.

Progression-free survival3

PFS: Median follow-up: 23.5 months (95% CI: 17.7, 24)3*

Breyanzi duration of response in R/R MCL in TRANSCEND MCL Cohort, graph Breyanzi duration of response in R/R MCL in TRANSCEND MCL Cohort, graph

Months CR PR Nonresponders Total
0 60 9 14 83
3 55 5 1 61
6 48 0 1 49
9 35 1 36
12 35 1 32
15 28 1 29
18 20 1 21
21 18 1 19
24 6 0 6
27 0 0

Learn more about the efficacy and safety of Breyanzi.

Analysis limitations

  • PFS was a secondary endpoint of TRANSCEND MCL Cohort 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 in a single-arm trial. The statistical significance of PFS is not known
  • PFS included survival data from patients who completed TRANSCEND MCL Cohort and enrolled in the subsequent long-term follow-up study2

Overall survival3

OS: Median follow-up: 23.8 months (95% CI: 23.6, 24.0)3*

Breyanzi duration of response in R/R MCL in TRANSCEND MCL Cohort, graph Breyanzi duration of response in R/R MCL in TRANSCEND MCL Cohort, graph

Months CR PR Nonresponders Total
0 60 9 14 83
3 57 8 7 72
6 54 6 5 65
9 47 6 4 57
12 40 4 2 46
15 36 4 2 42
18 32 3 2 37
21 26 3 2 31
24 14 2 0 16
27 7 1 8
30 7 1 8
33 7 1 8
36 5 0 5
39 4 4
42 4 4
45 4 4
48 4 4
51 3 2
54 3 2
57 1 1
60 1 1
63 0 0

Learn more about the efficacy and safety of Breyanzi.

Analysis limitations

  • OS was a secondary endpoint of TRANSCEND MCL Cohort and was not statistically tested in the setting of a single-arm trial
  • OS data are not in the Prescribing Information and should be interpreted with caution in a single-arm trial. The statistical significance of OS is not known
  • OS included survival data from patients who completed TRANSCEND MCL Cohort and enrolled in the subsequent long-term follow-up study2

*Reverse Kaplan-Meier method was used to obtain median follow-up and its 95% CI.3

BTKi, Bruton tyrosine kinase inhibitor; CI, confidence interval; CR, compete response; DOR, duration of response; IRC, Independent Review Committee; MCL, mantle cell lymphoma; mOS, median overall survival; mPFS, median progression-free survival; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; PR, partial response; R/R, relapsed or refractory.

An open-label, multicenter, single-arm trial

Choose Breyanzi® for adults with R/R MCL after ≥2 BTKis1,2

Breyanzi TRANSCEND MCL Cohort trial design, graphic Breyanzi TRANSCEND MCL Cohort trial design, graphic
  • Primary endpoint: ORR (per the 2014 Lugano classification, including bone marrow biopsy assessments, as assessed by IRC) and safety1,3
  • Select secondary endpoints: CR, DOR, PFS, and OS2

Of 89 patients who underwent leukapheresis, 71 received BREYANZI and the median dose administered was 99.8 x 106 CAR-positive viable T cells (range: 90 to 103 x 106 CAR-positive viable T cells).

The primary efficacy analysis included a total of 68 patients with MCL who received at least 2 prior lines of therapy including a BTKi, had PET-positive disease at study baseline or after bridging therapy, received conforming product in the intended dose range, and had at least 6 months of follow-up from the date of first response.

Studied in patients you are likely to see in your practice

Broad eligibility criteria in TRANSCEND MCL Cohort make Breyanzi accessible to more patients.

  • 15% (10/68) of patients were treated in an outpatient setting
  • Bridging therapy is an option; 65% (44/68) received bridging therapy

Learn more about the efficacy and safety of Breyanzi.

*Additional eligibility criteria applied.2

†No prespecified threshold for blood counts.1

‡Measurable disease reconfirmed prior to lymphodepletion.2

ALT, alanine aminotransferase; BTKi, Bruton tyrosine kinase inhibitor; CAR, chimeric antigen receptor; CI, confidence interval; CNS, central nervous system; CrCl, creatinine clearance; CR compete response; CY, cyclophosphamide; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; FLU, fludarabine; HSCT, hematopoietic stem cell transplantation; IRC, Independent Review Committee; LVEF, left ventricular ejection fraction; MCL, mantle cell lymphoma; ORR, overall response rate; OS, overall survival; PET, positron emission tomography; PFS, progression-free survival; PR, partial response; R/R, relapsed or refractory; TP53, tumor protein 53; ULN, upper limit of normal.

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 mantle cell lymphoma (MCL) who have received at least 2 prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor.
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 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 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 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.
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 MCL are cytokine release syndrome, fatigue, musculoskeletal pain, and encephalopathy. The most common Grade 3-4 laboratory abnormalities include neutrophil count decrease, white blood cell decrease, and platelet count 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. Wang M, Siddiqi T, Gordon L, et al. Lisocabtagene maraleucel in relapsed/refractory mantle cell lymphoma: primary analysis of the mantle cell lymphoma cohort from TRANSCEND NHL 001, a phase I multicenter seamless design study. J Clin Oncol. 2023;00:1-12. doi:10.1200/JCO.23.02214.
  3. Data on file. BMS-REF-LIS-0051. Princeton, NJ: Bristol-Myers Squibb Company; 2024.

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References
  1. Breyanzi [package insert]. Summit, NJ: Bristol-Myers Squibb Company; 2024.
  2. Wang M, Siddiqi T, Gordon L, et al. Lisocabtagene maraleucel in relapsed/refractory mantle cell lymphoma: primary analysis of the mantle cell lymphoma cohort from TRANSCEND NHL 001, a phase I multicenter seamless design study. J Clin Oncol. 2023;00:1-12. doi:10.1200/JCO.23.02214.
  3. Data on file. BMS-REF-LIS-0051. Princeton, NJ: Bristol-Myers Squibb Company; 2024.