| TRANSFORM Trial (n=19)6† | PILOT Trial (n=20)7† | |
|---|---|---|
| Required hospitalization‡ | 13/19 | 9/20 |
| Admitted ≤72 hours§ | 4/13 | 2/9 |
| Admitted >72 hours§ | 9/13 | 7/9 |
| Median time to admission§ | 9 (range: 2-161 days) | 6 (range: 5-10 days) |
| Median number of days spent in the hospital§ | 9 (range: 4-33) | 8 (range: 7-11) |
| Admitted to the ICU§ | 0 | 1/9 |
Breyanzi® is THE ONE with a safety profile you can count on in 2L and 3L+ LBCL1
Breyanzi was evaluated in 2L in TRANSFORM (N=89) and PILOT (N=61) and in 3L+ in TRANSCEND (N=268)2
Majority of CRS events were low grade and most resolved quickly2
Across clinical trials of Breyanzi (N=702), 54% of patients experienced Any Grade CRS and 3.2% of patients experienced Grade ≥3 CRS. Median time to onset of CRS was 5 (range: 1-63) days; median duration was 5 (range: 1-37) days.2
TRANSFORM AND PILOT TRIALS (N=150)1
TRANSCEND TRIAL (N=268)1
The majority of patients in 2L LBCL trials (N=150) did not experience CRS of any grade1
No Grade 4 of 5 CRS events were experienced in 2L LBCL trials1
In clinical trials of Breyanzi (N=702), one patient had fatal CRS and 5 patients had ongoing CRS at the time of death.2
Of the patients who received Breyanzi for LBCL1:
- 23% received tocilizumab and/or a corticosteroid for CRS
- 10% received tocilizumab only
- 2.2% received corticosteroids only
Use of tocilizumab + corticosteroids were low.
Most common manifestations of CRS (≥10%) in clinical trials of Breyanzi (N=702)2
The most common manifestations of CRS (≥10%) included fever, hypotension, chills, tachycardia, hypoxia, and headache.
Breyanzi is THE ONE CAR T with primarily low-grade CRS events with no steroid
prophylaxis in 2L LBCL trials2
CRS warnings and precautions2
- 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 for signs and symptoms of CRS. Instruct patients to remain within proximity of a healthcare facility for at least 2 weeks to monitor for signs and symptoms of CRS. 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
Breyanzi is THE ONE with primarily low-grade CRS events—most of which occurred
within 2 weeks of treatment when patients were near the treatment center2,3
In clinical trials of Breyanzi (N=702), 98% of CRS events occurred within 2 weeks post infusion. Median time to
onset of CRS was 5 (range: 1-63) days; median duration was 5 (range: 1-37) days2,3
2L, second-line; 3L, third-line; CAR, chimeric antigen receptor; CRS, cytokine release syndrome; LBCL, large B-cell lymphoma; NT, neurologic toxicity.
Majority of NT events were low grade and most resolved quickly2
Across clinical trials of Breyanzi (N=702), 31% of patients experienced NT and 10% of patients experienced Grade ≥3 NT. Median time to onset for NT was 8 (range: 1-63) days; median duration was 7 (range: 1-119) days.2
TRANSFORM AND PILOT TRIALS (N=150)1
TRANSCEND TRIAL (N=268)1
Breyanzi gives patients with 2L LBCL the power of CAR T with ≤4% ICU admissions due to NT2,4
2% and 3.3% of patients were admitted to the ICU due to NT in TRANSFORM and PILOT, respectively4,5
NT warnings and precautions2
- 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, have also occurred
- Monitor patients daily for at least 7 days following Breyanzi infusion for signs and symptoms of NTs and assess for other causes of neurological symptoms. Instruct patients to remain within proximity of a healthcare facility for at least 2 weeks to monitor for signs and symptoms of NT. 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
The majority of patients in 2L LBCL trials did not experience NT events of any grade1
No Grade 4 or 5 NT events were reported in 2L LBCL trials1
NT-related clinical trial details (N=702)2
- 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
Breyanzi is THE ONE with primarily low-grade NT events—most of which occurred
within 2 weeks of treatment when patients were near the treatment center2,3
In pivotal clinical trials of Breyanzi (N=702), 88% of NT events occurred within 2 weeks post infusion.
Median time to onset for NT was 8 (range: 1-63) days; median duration was 7 (range: 1-119) days2,3
2L, second-line; 3L, third-line; CAR, chimeric antigen receptor; CRS, cytokine release syndrome; LBCL, large B-cell lymphoma; NT, neurologic toxicity.
Breyanzi: THE ONE CAR T with up to 1/3 of patients treated in the outpatient setting2*
Outpatient hospitalization across Breyanzi 2L trials
No ICU admissions for 2L LBCL transplant-eligible patients treated in
the outpatient setting6
Ensure that 2 doses of tocilizumab are available prior to infusion of Breyanzi.2
Breyanzi trials were not designed to evaluate the difference between patients treated in an outpatient setting compared with the full population.
Data based on outpatient cohorts in the TRANSFORM and PILOT trials. *In TRANSFORM and PILOT, 21% and 33% of patients were treated in the outpatient setting, respectively.2
†N-value reflects the number of patients treated in an outpatient setting.
‡Calculations based on patients treated in an outpatient setting.
§Calculations based on patients who required hospitalization.
2L, second-line; 3L, third-line; CAR, chimeric antigen receptor; CRS, cytokine release syndrome; LBCL, large B-cell lymphoma; NT, neurologic toxicity.
Breyanzi adverse reactions observed across trials2
Incidence and severity of AEs were consistent across LBCL clinical trials2
Adverse reactions observed in at least 10% |
TRANSFORM Trial (N=89) | PILOT Trial (N=61) | ||
|---|---|---|---|---|
| Any Grade (%) | Grade ≥3 (%) | Any Grade (%) | Grade ≥3 (%) | |
| Blood and lymphatic system disorders | ||||
| Febrile neutropenia | 10 | 10 | - | - |
| Cardiac disorders | ||||
| Tachycardiaa,q | 15 | 1.1 | 10 | 0 |
| Gastrointestinal disorders | ||||
| Nausea | 24 | 0 | 25 | 1.6 |
| Constipation | 20 | 2.2 | 11 | 0 |
| Diarrhea | 18 | 0 | 15 | 0 |
| Abdominal painb | 13 | 2.2 | - | - |
| Vomiting | 11 | 0 | - | - |
| General disorders and administration site conditions | ||||
| Fever | 55 | 3.4 | 38 | 1.6 |
| Fatiguec,r | 28 | 1.1 | 44 | 1.6 |
| Edemad,s | 13 | 0 | 20 | 0 |
| Immune system disorders | ||||
| Cytokine release syndromef | 49 | 1.1 | 39 | 1.6 |
| Infections and infestationse | ||||
| Bacterial infectious disorders | 12 | 6 | 10 | 3.3 |
| Infections with pathogen unspecifiedt | 12 | 6 | 13 | 4.9 |
| Sepsisf | 10 | 7 | - | - |
| Upper respiratory tract infectionu | - | - | 13 | 0 |
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 15 | 0 | 13 | 1.6 |
| Musculoskeletal and connective tissue disorders | ||||
| Musculoskeletal paing,v | 36 | 3.4 | 23 | 4.9 |
| Nervous system disorders | ||||
| Headacheh | 34 | 6 | 11 | 1.6 |
| Dizzinessi,w | 20 | 1.1 | 16 | 1.6 |
| Motor dysfunctionj | 12 | 3.4 | - | - |
| Tremork,x | 11 | 1.1 | 16 | 0 |
| Encephalopathyy | - | - | 23 | 4.9 |
| Psychiatric disorders | ||||
| Insomnial | 15 | 0 | 11 | 0 |
| Respiratory, thoracic, and mediastinal disorders | ||||
| Coughm,z | 11 | 0 | 18 | 0 |
| Dyspneaaa | - | - | 16 | 4.9 |
| Skin and subcutaneous tissue disorders | ||||
| Rashn | 12 | 1.1 | - | - |
| Vascular disorders | ||||
| Hypotensiono,bb | 15 | 2.2 | 23 | 1.6 |
| Hemorrhagep | 12 | 0 | - | - |
| Hypertension | - | - | 10 | 4.9 |
TRANSFORM
aTachycardia includes atrial flutter, sinus tachycardia, supraventricular tachycardia, tachycardia.
bAbdominal pain includes abdominal pain, abdominal pain lower, abdominal tenderness.
cFatigue includes asthenia, fatigue, malaise.
dEdema includes edema peripheral, localized edema, pleural effusion swelling.
eInfections and infestations are grouped per high-level grouped term.
fSepsis includes bacteremia, bacterial sepsis, enterococcal bacteremia, Escherichia bacteremia, Klebsiella bacteremia, Klebsiella sepsis, sepsis, septic shock, staphylococcal bacteremia.
gMusculoskeletal pain includes arthralgia, back pain, bone pain, flank pain, musculoskeletal chest pain, musculoskeletal pain, musculoskeletal stiffness, myalgia, neck pain, osteoarthritis, pain in extremity.
hHeadache includes headache, migraine, migraine with aura.
iDizziness includes dizziness, dizziness postural, syncope, vertigo.
jMotor dysfunction includes fine motor skill dysfunction, muscle spasms, muscular weakness.
kTremor includes resting tremor, tremor, essential tremor.
lInsomnia includes insomnia, sleep disorder.
mCough includes cough, productive cough.
nRash includes catheter site rash, dermatitis acneiform, dermatitis exfoliative generalized, erythema multiforme, rash, rash maculopapular, rash pruritic.
oHypotension includes hypotension, orthostatic hypotension.
pHemorrhage includes conjunctival hemorrhage, cystitis hemorrhagic, epistaxis, gastrointestinal hemorrhage, hematoma, hematuria, retinal hemorrhage, vaginal hemorrhage.
PILOT
qTachycardia includes atrial fibrillation, sinus tachycardia, tachycardia.
rFatigue includes asthenia, fatigue, malaise.
sEdema includes edema peripheral, pleural effusion, swelling.
tGrouped per high-level grouped term.
uUpper respiratory tract infection includes nasal congestion, paranasal sinus hypersecretion, rhinitis, rhinorrhea, upper respiratory tract infection.
vMusculoskeletal pain includes arthralgia, back pain, bone pain, flank pain, musculoskeletal chest pain, musculoskeletal pain, musculoskeletal stiffness, myalgia, neck pain, osteoarthritis, pain in extremity, spinal pain.
wDizziness includes dizziness, dizziness postural, syncope, vertigo.
xTremor includes resting tremor, tremor.
yEncephalopathy includes amnesia, apraxia, cognitive disorder, confusional state, depressed level of consciousness, disturbance in attention, dyscalculia, encephalopathy, lethargy, memory impairment, mental status changes, somnolence.
zCough includes cough, productive cough.
aaDyspnea includes acute respiratory distress syndrome, dyspnea, tachypnea, wheezing.
bbHypotension includes hypotension, orthostatic hypotension.
Adverse reactions observed in at least 10% |
TRANSCEND Trial (N=268) | |
|---|---|---|
| Any Grade (%) | Grade ≥3 (%) | |
| Cardiac disorders | ||
| Tachycardiaa | 25 | 0 |
| Gastrointestinal disorders | ||
| Nausea | 33 | 1.5 |
| Diarrhea | 26 | 0.4 |
| Constipation | 23 | 0 |
| Abdominal painb | 21 | 3.0 |
| Vomiting | 21 | 0.4 |
| General disorders and administration site conditions | ||
| Fatiguec | 48 | 3.4 |
| Edemad | 21 | 1.1 |
| Fever | 16 | 0 |
| Chills | 12 | 0 |
| Immune system disorders | ||
| Cytokine release syndrome | 46 | 4.1 |
| Infections and infestationse | ||
| Infections with pathogen unspecifiedf | 29 | 16 |
| Bacterial infectiong | 13 | 5 |
| Upper respiratory tract infectionh | 13 | 0.7 |
| Viral infection | 10 | 1.5 |
| Metabolism and nutrition disorders | ||
| Decreased appetite | 28 | 2.6 |
| Musculoskeletal and connective tissue disorders | ||
| Musculoskeletal paini | 37 | 2.2 |
| Nervous system disorders | ||
| Headachej | 30 | 1.1 |
| Encephalopathyk | 29 | 9 |
| Dizzinessl | 24 | 2.6 |
| Tremorm | 16 | 0 |
| Peripheral neuropathyn | 11 | 0 |
| Aphasiao | 10 | 2.2 |
| Motor dysfunctionp | 10 | 1.1 |
| Psychiatric disorders | ||
| Insomniaq | 14 | 0.4 |
| Anxietyr | 10 | 0 |
| Deliriums | 10 | 2.2 |
| Renal and urinary disorders | ||
| Renal failuret | 11 | 3.0 |
| Respiratory, thoracic, and mediastinal disorders | ||
| Coughu | 23 | 0 |
| Dyspneav | 16 | 2.6 |
| Skin and subcutaneous tissue disorders | ||
| Rashw | 13 | 0.4 |
| Vascular disorders | ||
| Hypotensionx | 26 | 3.4 |
| Hypertension | 14 | 4.5 |
| Hemorrhagey | 10 | 1.5 |
TRANSCEND
aTachycardia includes heart rate increased, sinus tachycardia, tachycardia.
bAbdominal pain includes abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, abdominal tenderness.
cFatigue includes asthenia, fatigue, malaise.
dEdema includes edema, edema peripheral, fluid overload, fluid retention, generalized edema, hypervolemia, peripheral swelling, pulmonary congestion, pulmonary edema, swelling.
eInfections and infestations are grouped by pathogen type and selected clinical syndromes.
fInfections with pathogen unspecified contains febrile neutropenia (9%).
gBacterial infection includes infections by pathogen type plus appendicitis, diverticulitis, peritonitis, skin infection, tooth infection.
hUpper respiratory tract infections include nasopharyngitis, pharyngitis, rhinitis, rhinovirus infection, sinusitis, upper respiratory tract congestion, upper respiratory tract infection.
iMusculoskeletal pain includes arthralgia, back pain, bone pain, musculoskeletal chest pain, musculoskeletal discomfort, musculoskeletal pain, musculoskeletal stiffness, myalgia, neck pain, pain in extremity, spinal pain.
jHeadache includes headache, head discomfort, migraine, sinus headache.
kEncephalopathy includes amnesia, bradyphrenia, cognitive disorder, confusional state, depersonalization/derealization disorder, depressed level of consciousness, disturbance in attention, encephalopathy, flat affect, hypersomnia, incoherent, lethargy, leukoencephalopathy, loss of consciousness, memory impairment, mental impairment, mental status changes, somnolence.
lDizziness includes dizziness, presyncope, syncope, vertigo.
mTremor includes essential tremor, resting tremor, tremor.
nPeripheral neuropathy includes hyperesthesia, hypoesthesia, meralgia paresthetica, neuralgia, neuropathy peripheral, paresthesia, peripheral sensory neuropathy, sciatica, sensory loss.
oAphasia includes aphasia, disorganized speech, dysarthria, dysphemia, dysphonia, slow speech, speech disorder.
pMotor dysfunction includes eyelid ptosis, motor dysfunction, muscle rigidity, muscle spasms, muscle spasticity, muscle tightness, muscle twitching, muscular weakness, myoclonus, myopathy.
qInsomnia includes insomnia, somnambulism.
rAnxiety includes anxiety, panic attack.
sDelirium includes agitation, delirium, delusion, disorientation, hallucination, ‘hallucination, visual’, irritability, restlessness.
tRenal failure includes acute kidney injury, blood creatinine increased, chronic kidney disease, renal failure, renal injury.
uCough includes cough, productive cough, upper-airway cough syndrome.
vDyspnea includes acute respiratory failure, dyspnea, dyspnea exertional, respiratory failure.
wRash includes erythema, dermatitis acneiform, perineal rash, rash, rash erythematous, rash macular, rash maculopapular, rash morbilliform, rash papular, rash pruritic, rash pustular.
xHypotension includes hypotension, orthostatic hypotension.
yHemorrhage includes catheter site hemorrhage, conjunctival hemorrhage, epistaxis, hematoma, hematuria, hemorrhage, hemorrhage intracranial, pulmonary hemorrhage, retinal hemorrhage, vaginal hemorrhage.
Most common adverse reactions across Breyanzi trials2
2L LBCL: TRANSFORM (N=89) and PILOT (N=61)
- Serious adverse reactions occurred in 38% of patients in TRANSFORM and 33% of patients in PILOT. The most common nonlaboratory, serious adverse reactions (>2%) were CRS,* fever, febrile neutropenia, headache, aphasia, COVID-19 infection, confusional state, gastrointestinal hemorrhage, muscular weakness, musculoskeletal pain, pulmonary embolism, and sepsis
- The most common nonlaboratory adverse reactions (≥20%) were fever, CRS, musculoskeletal pain, headache, fatigue, nausea, constipation, dizziness, encephalopathy, hypotension, and edema
3L+ LBCL: TRANSCEND (N=268)
- Serious adverse reactions occurred in 46% of patients. The most common nonlaboratory serious adverse reactions (>2%) were CRS,* encephalopathy, sepsis, febrile neutropenia, aphasia, pneumonia, fever, hypotension, dizziness, and delirium. Fatal adverse reactions occurred in 4% of patients
- The most common nonlaboratory adverse reactions (≥20%) were fatigue, CRS, musculoskeletal pain, nausea, headache, encephalopathy, infections (pathogen unspecified), decreased appetite, diarrhea, hypotension, tachycardia, dizziness, cough, constipation, abdominal pain, vomiting, and edema
In clinical trials of Breyanzi (N=702)
- Grade ≥3 infections occurred in 12% of all patients. Infections of any grade occurred in 34% of patients
*In clinical trials of Breyanzi (N=702), one patient had fatal CRS and 5 patients had ongoing CRS at the time of death.1
2L, second-line; 3L, third-line; AE, adverse event; CRS, cytokine release syndrome; LBCL, large B-cell lymphoma.
References
- Data on file. BMS-REF-LIS-0052. Princeton, NJ: Bristol-Myers Squibb Company; 2024.
- Breyanzi [package insert]. Summit, NJ: Bristol-Myers Squibb Company; 2025.
- Kamdar M, Solomon SR, Arnason J, et al. Lisocabtagene maraleucel versus standard of care for second-line relapsed/refractory large B-cell lymphoma: 3-year follow-up from the randomized, phase III TRANSFORM study. J Clin Oncol. Published online July 7, 2025. doi:10.1200/JCO-25-00399
- Kamdar M, Solomon S, Arnason J, et al. Lisocabtagene maraleucel versus standard of care with salvage chemotherapy followed by autologous stem cell transplantation as second-line treatment in patients with relapsed or refractory large B-cell lymphoma (TRANSFORM): results from an interim analysis of an open-label, randomised, phase 3 trials. Supplementary appendix. Lancet. 2022;399(10343):2294-2308.
- Sehgal A, Hoda D, Riedell PA, et al. Lisocabtagene maraleucel as second-line therapy in adults with relapsed or refractory large B-cell lymphoma who were not intended for haematopoietic stem cell transplantation (PILOT): an open-label, phase 2 study. Lancet Oncol. 2022;23(8):1066-1077. doi:10.1016/S1470-2045(22)00339-4
- Data on file. BMS-REF-LIS-0023. Princeton, NJ: Bristol-Myers Squibb Company; 2024.
- Sehgal A, Hoda D, Riedell PA, et al. Lisocabtagene maraleucel as second-line therapy in adults with relapsed or refractory large B-cell lymphoma who were not intended for haematopoietic stem cell transplantation (PILOT): an open-label, phase 2 study. Supplementary appendix. Lancet Oncol. 2022;23(8):1066-1077. doi:10.1016/S1470-2045(22)00339-4
