Breyanzi^®: THE ONE with a safety profile in 3L+ MCL that builds on evidence seen in clinical trials and other lymphoma indications¹

In pivotal clinical trials (N=702)^1,2

Across clinical trials of Breyanzi (N=702), 31% of patients experienced Any Grade 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) days¹

In the real-world setting (N=877)²

Analysis limitations: Real-world data outcomes should be interpreted with caution. Analyses not intended to be compared to controlled clinical trial data. Causality cannot be established based on real-world data. Results may not be generalizable to other disease states or cell therapy products.

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 toxicities 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 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 corticosteroid as needed
• Counsel patients to seek immediate medical attention should signs or symptoms of NT occur at any time

Study design²

• Data from pivotal trials (TRANSCEND NHL 001, TRANSCEND CLL 004, TRANSFORM, PILOT, and TRANSCEND FL) included patients treated with Breyanzi for R/R LBCL, CLL/SLL, MCL, and FL; data from the Center for International Blood and Marrow Transplant Research (CIBMTR) Registry included patients who received Breyanzi for R/R LBCL and had ≥1 assessment after infusion
• Objectives of the study were to report CRS and NT rate and timing in patients treated with Breyanzi in pivotal clinical trials across indications or in the real-world standard of care (SoC) setting to inform safety monitoring requirements
• Outcomes were incidence, onset, grade, and duration of CRS and NT from pivotal trials and the CIBMTR Registry

3L, third-line; CAR, chimeric antigen receptor; CLL, chronic lymphocytic leukemia; CRS, cytokine release syndrome; FL, follicular lymphoma; LBCL, large B-cell lymphoma; MCL, mantle cell lymphoma; NHL, non-Hodgkin lymphoma; NT, neurologic toxicity; R/R, relapsed or refractory; SLL, small lymphocytic lymphoma.

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)¹

• Grade ≥3 infections occurred in 12% of patients. Infections of any grade were reported in 34% of patients

Adverse reactions in ≥10% of patients treated with Breyanzi in TRANSCEND MCL (N=88)¹

*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 maculopapular, rash pruritic.

^pHypotension includes hypotension, orthostatic hypotension.

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

3L, third-line; CAR, chimeric antigen receptor; CRS, cytokine release syndrome; MCL, mantle cell lymphoma; NT, neurologic toxicity.