Breyanzi®: A safety profile in R/R MCL you can count on that builds on evidence seen in clinical trials and other lymphoma indications1

The primary safety analysis was conducted in the full safety set (N=88), which included all patients who received a single dose of CAR-positive viable T cells.

3.2% Grade ≥3 CRS events reported in Breyanzi trials1

Majority of CRS events were low grade and most resolved quickly

Breyanzi grade of cytokine release syndrome (CRS) in TRANSCEND MCL Cohort Breyanzi grade of cytokine release syndrome (CRS) in TRANSCEND MCL Cohort

Breyanzi offers the flexibility of inpatient or outpatient administration for appropriate patients1

CRS-related clinical trial details (N=702)1
  • 29.5% of patients received tocilizumab and/or corticosteroids
    • 1.7% used corticosteroids only
    • 14.5% used tocilizumab only
    • Prophylactic systemic corticosteroids were not used in Breyanzi trials
  • CRS resolved in 98% of patients with a median duration of 5 (range 1-37) days
  • One patient had fatal CRS and 5 patients had ongoing CRS at the time of death
  • The most common manifestations of CRS (≥10%) included fever, hypotension, chills, tachycardia, hypoxia, and headache
  • In TRANSCEND MCL Cohort (N=88), 1.1% of patients experienced Grade ≥3 CRS
Cytokine release syndrome warnings and precautions1
  • CRS, including fatal or life-threatening reactions, occurred following treatment with Breyanzi
  • 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
  • Ensure that 2 doses of tocilizumab are available prior to infusion of Breyanzi
  • Monitor patients daily for at least 7 days following Breyanzi infusion at a REMS-certified healthcare facility for signs and symptoms of CRS. Monitor patients for signs or symptoms of CRS for at least 4 weeks after infusion. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated
  • Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time
CAR, chimeric antigen receptor; CRS, cytokine release syndrome; MCL, mantle cell lymphoma; NT, neurologic toxicity; REMS, Risk Evaluation and Mitigation Strategy; R/R, relapsed or refractory.
10% Grade ≥3 NT in Breyanzi trials1

Majority of NT events were low grade and most resolved quickly

Breyanzi grade of neurologic toxicities (NT) in TRANSCEND MCL Cohort Breyanzi grade of neurologic toxicities (NT) in TRANSCEND MCL Cohort

Breyanzi offers the flexibility of inpatient or outpatient administration for appropriate patients1

NT-related clinical trial details (N=702)1
  • NTs resolved in 88% of cases with a median duration of 7 (range 1-119) days
  • 82% of patients with NT developed CRS
  • The most common NTs (≥5%) included encephalopathy, tremor, aphasia, delirium, and headache
Neurologic toxicity warnings and precautions1
  • NTs 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
  • Monitor patients daily for at least 7 days following Breyanzi infusion at a REMS-certified healthcare facility for signs and symptoms of NTs and assess for other causes of neurological symptoms. Monitor patients for signs or symptoms of NTs for at least 4 weeks after infusion and treat promptly. Manage NT with supportive care and/or corticosteroids as needed
  • Counsel patients to seek immediate medical attention should signs or symptoms of neurologic toxicity occur at any time
CAR, chimeric antigen receptor; CRS, cytokine release syndrome; MCL, mantle cell lymphoma; NT, neurologic toxicity; REMS, Risk Evaluation and Mitigation Strategy; R/R, relapsed or refractory.
The most common adverse reactions observed in TRANSCEND MCL Cohort (N=88)1
  • Serious adverse reactions occurred in 53% of patients. The most common nonlaboratory serious adverse reactions (>2%) were CRS, confusional state, fever, encephalopathy, mental status changes, pleural effusion, upper respiratory tract infection, and decreased appetite. Fatal adverse reactions occurred in 4.5% of patients
    • One patient with MCL who received 3 prior lines of therapy developed a fatal case of cryptococcal meningoencephalitis 35 days after treatment with Breyanzi
  • The most common nonlaboratory adverse reactions (≥20%) were CRS, fatigue, musculoskeletal pain, encephalopathy, edema, headache, and decreased appetite
In clinical trials of Breyanzi (N=702)
  • Grade ≥3 infections occurred in 12% of patients. Infections of any grade were reported in 34% of patients
This table includes adverse reactions observed in ≥10% of the full population (N=88) in TRANSCEND MCL Cohort1
Adverse reactions* Any Grade (%) Grade 3 or higher (%)
Cardiac disorders
Tachycardiaa 17 3.4
Gastrointestinal disorders
Nausea 18 2.3
Diarrhea 17 0
Abdominal painb 15 3.4
Constipation 14 0
General disorders and administration site conditions
Fatiguec 39 2.3
Edemad 25 1.1
Fevere 17 0
Chills 11 0
Immune system disorders
Cytokine release syndrome 61 1.1
Infections and infestations
Infections with pathogen unspecifiedf 16 6
Upper respiratory tract infectiong 13 2.3
Metabolism and nutrition disorders
Decreased appetite 21 4.5
Musculoskeletal and connective tissue disorders
Musculoskeletal painh 38 2.3
Nervous system disorders
Encephalopathyi 30 9
Headache 23 0
Dizzinessj 11 2.3
Motor dysfunctionk 11 0
Tremor 11 0
Psychiatric disorders
Insomnial 14 0
Anxiety 13 1.1
Renal and urinary disorders
Renal failurem 15 0
Respiratory, thoracic, and mediastinal disorders
Dyspnean 11 0
Cough 10 0
Skin and subcutaneous tissue disorders
Rasho 11 1.1
Vascular disorders
Hypotensionp 15 0
Hemorrhageq 10 0
Hypertension 10 3.4

*Includes adverse reactions up to 90 days following treatment with Breyanzi.1

aTachycardia includes atrial fibrillation, sinus tachycardia, tachycardia, ventricular tachycardia.

bAbdominal pain includes abdominal discomfort, abdominal distension, abdominal pain, abdominal pain upper.

cFatigue includes asthenia, fatigue, malaise.

dEdema includes hypervolemia, localized edema, edema, edema peripheral, peripheral swelling, pleural effusion, pulmonary edema.

eFever includes pyrexia.

fGrouped per high-level grouped term.

gUpper respiratory tract infection includes nasal congestion, rhinitis, rhinorrhea, rhinovirus infection, upper respiratory tract infection.

hMusculoskeletal pain includes arthralgia, back pain, bone pain, musculoskeletal pain, myalgia, neck pain, pain in extremity.

iEncephalopathy includes confusional state, depressed level of consciousness, encephalopathy, lethargy, memory impairment, mental status changes, somnolence.

jDizziness includes dizziness, dizziness postural, syncope, vertigo.

kMotor dysfunction includes fine motor skill dysfunction, muscle spasms, muscle tightness, muscular weakness.

lInsomnia includes insomnia, sleep disorder.

mRenal failure includes acute kidney injury, blood creatinine increased.

nDyspnea includes dyspnea, tachypnea, wheezing.

oRash includes dermatitis contact, rash, rash erythematous, rash macular, rash maculo-papular, rash pruritic.

pHypotension includes hypotension, orthostatic hypotension.

qHemorrhage includes catheter site hemorrhage, epistaxis, hematoma, hematuria, hemorrhage, hemorrhoidal hemorrhage, rectal hemorrhage.

CRS, cytokine release syndrome; MCL, mantle cell lymphoma; NT, neurologic toxicity; R/R, relapsed or refractory.

This website is best viewed
using the horizontal display on
your tablet device.

This website is best viewed
using the vertical display on
your mobile device.

Reference
  1. Breyanzi [package insert]. Summit, NJ: Bristol-Myers Squibb Company; 2024.