An open-label, multicenter, single-arm trial

Breyanzi®: THE ONE evaluated in adult patients with R/R MCL who have received at least 2 prior lines of systemic therapy, including a BTKi1

Primary endpoints: ORR by an IRC and safety1,2

Select secondary endpoints: CR, DOR, PFS, and OS2

Bridging chemotherapy was permitted between leukapheresis and lymphodepleting chemotherapy.1

Breyanzi provides deep and durable complete responses in a one-time infusion1*

Response rates (N=68)1†

Chart of data from the trial including overall response rate, complete response, and partial response. 85% of Breyanzi patients achieved overall response.

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

Subgroup analysis limitations:

  • These analyses are exploratory in nature, and definitive conclusions should not be drawn
  • Numbers may not be available in the Prescribing Information
Chart of overall response rates by mutation. Patients who achieved an overall response included 80% of patients with blastoid morphology, 77% of patients with TP53 mutations, and 89% of patients with Ki67 ≥30%

Overall response rates by prespecified subgroups3‡

Overall response rates by prespecified subgroups including age, sex, prior HSCT, response to last therapy, CNS disease status, chemotherapy response, Ki67 proliferation index, TP53 mutation status, blastoid morphology, and bridging therapy.

Power to deliver durable response in R/R MCL1

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

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

Median duration of response in TRANSCEND MCL Cohort was 13.3 months for all responders, 17.5 months for patients with complete response, and 2.2 months for patients with partial response.

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

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

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

‡2-sided 95% exact Clopper-Pearson CIs.3

§Per the 2014 Lugano classification (including bone marrow biopsy assessments), as assessed by an IRC.1

∥Kaplan-Meier method was used to obtain 2-sided 95% CIs.1

BOR, best overall response; BTKi, Bruton tyrosine kinase inhibitor; CI, confidence interval; CNS, central nervous system; CR, complete response; DOR, duration of response; HSCT, hematopoietic stem cell transplantation; IRC, Independent Review Committee; 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; TP53, tumor protein 53.

Progression-free survival

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

Graph of Breyanzi progression-free survival (PFS) median follow-up at 23.5 months in TRANSCEND MCL trial. Median progression-free survival was 8.5 months for the total population, 18.4 months for patients with complete response, and 3.2 months for patients with partial response.

18.4 months mPFS for Breyanzi-treated patients achieving a
complete response (95% CI: 8.3, 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 MCL 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

Overall survival

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

With a median follow-up of 23.8 months, median overall survival in the TRANSCEND MCL Cohort was 17.1 months, 36.3 months for patients who had a complete response, 15.3 months for patients who had a partial response, and 4.3 months for patients who did not respond to treatment.

Analysis limitations

  • OS data are not in the Prescribing Information and should be interpreted with caution
  • OS was a secondary endpoint in TRANSCEND MCL 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 obtain median follow-up and its 95% CI.3

BTKi, Bruton tyrosine kinase inhibitor; CI, confidence interval; CR, complete response; DOR, duration of response; IRC, Independent Review Committee; MCL, mantle cell lymphoma; mOS, median overall survival; mPFS, median progression-free survival; N/R, nonresponder; NR, not reached; 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: THE ONE for adults with R/R MCL who have received at least 2 prior lines of systemic therapy, including a BTKi1

Hypothetical Breyanzi MCL patients

Screening1,2*

Broad enrollment criteria:

  • Adult patients with R/R MCL who received ≥2 lines of systemic therapy, including a BTKi
  • Age ≥18 years
  • ECOG PS ≤1
  • LVEF ≥40%
  • CrCl >30 mL/min
  • ALT ≤5x ULN
  • PET-positive MCL with confirmed tissue diagnosis
  • Secondary CNS lymphoma or prior HSCT allowed
  • Adequate bone marrow†

Enrollment and leukapheresis (N=89)

CAR T-cells manufacturing

Breyanzi manufacturing1

Bridging chemotherapy was permitted between leukapheresis and lymphodepleting chemotherapy; 65% (44/68) received bridging therapy

Lymphodepleting chemotherapy
infusion bag

Lymphodepletion1‡

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

Patients treated with Breyanzi (68/89)

Breyanzi infusion

Breyanzi infusion1

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

  • Primary endpoints: ORR (per the 2014 Lugano classification, including bone marrow biopsy assessments, as assessed by an IRC) and safety1,2
  • 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 × 106 CAR-positive viable T cells (range: 90 to 103 × 106 CAR-positive viable T cells).1

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.1

Studied in patients you are likely to see in your practice

Age (N=68)1  
Median age, years (range) 69 (36-86)
Prior therapies (N=68)1
Median number of prior therapies (range) 3 (2-11)
Prior BTKi 100%
Refractory§ to prior BTKi 56%
Prior stem cell transplantation 32%
High-risk features (N=68)1,3
Refractory to last therapy∥ 69%
High-risk feature  
Ki67 ≥30% 77%
Complex karyotype 31%
Blastoid morphology 29%
TP53 mutation 25%
CNS involvement 10%

Broad eligibility criteria in TRANSCEND MCL Cohort make Breyanzi accessible to more patients.1

  • 15% (10/68) of patients were treated in an outpatient setting1
  • Bridging therapy is an option; 65% (44/68) received bridging therapy1

*Additional eligibility criteria applied.

†No prespecified threshold for blood counts.1

‡Measurable disease reconfirmed prior to lymphodepletion.2

§Defined as any response to prior BTKi that was less than partial response.1

∥Defined as best response of partial response, stable disease, or progressive disease to last systemic or HSCT treatment with curative intent.1

ALT, alanine aminotransferase; BTKi, Bruton tyrosine kinase inhibitor; CAR, chimeric antigen receptor; CI, confidence interval; CNS, central nervous system; CR, complete response; CrCl, creatinine clearance; 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; R/R, relapsed or refractory; TP53, tumor protein 53; ULN, upper limit of normal.

References

  1. Breyanzi [package insert]. Summit, NJ: Bristol-Myers Squibb Company; 2025.
  2. Wang M, Siddiqi T, Gordon LI, 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. 2024;42(10):1146-1157. doi:10.1200/JCO.23.02214
  3. Data on file. BMS-REF-LIS-0051. 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 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.

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 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.

Bristol Myers Squibb logo
Legal Notice  Privacy Policy  Your Privacy Choices   Site Map  Contact Us

© 2025 Juno Therapeutics, Inc., a Bristol Myers Squibb company. All Rights Reserved.
BREYANZI is a trademark of Juno Therapeutics, Inc., a Bristol Myers Squibb company.
Cell Therapy 360 is a trademark of Celgene Corporation, a Bristol Myers Squibb company.

© 2025 Bristol Myers Squibb company.

2009-US-2500228

09/2025