New data from our multiple myeloma portfolio across targets and molecular approaches show significant progress toward our goal of transforming the treatment paradigm and improving outcomes for patients
Multiple first disclosures including preliminary Phase 1 data for subcutaneous administration of bispecific T cell engager alnuctamab in heavily pretreated multiple myeloma, preliminary Phase 1 results for GPRC5D CAR T in relapsed/refractory multiple myeloma and first results from the Phase 2 KarMMa-2 trial evaluating Abecma in high-risk multiple myeloma
New data for CD19-directed CAR T cell therapy Breyanzi, including longer-term follow up from pivotal Phase 3 TRANSFORM study in second-line relapsed or refractory large B-cell lymphoma
PRINCETON, N.J.–(BUSINESS WIRE)–$BMY #ASH—Bristol Myers Squibb (NYSE: BMY) today announced the presentation of research across its hematology portfolio at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition, which will take place in New Orleans, Louisiana, and virtually, from December 10 to 13, 2022. Data from more than 100 company-sponsored studies will be featured, including 34 oral presentations, highlighting the range of modalities, targets and research platforms the company is advancing and showcasing our commitment to scientific progress across hematologic diseases.
“Our presence at ASH underscores the transformational potential of our diverse pipeline, poised to deliver the next wave of advances in hematology,” said Samit Hirawat, M.D., executive vice president, chief medical officer, Global Drug Development, Bristol Myers Squibb. “These exciting data, spanning a variety of modalities and targets, demonstrate significant progress toward our goals of improving long-term outcomes across patient populations and finding solutions in important areas of remaining need.”
Key data being presented by Bristol Myers Squibb and its partners at the 2022 ASH Annual Meeting and Exposition include:
Cell Therapy
- Updated data including longer-term follow up from the primary analysis of the Phase 3 TRANSFORM study evaluating Breyanzi® (lisocabtagene maraleucel) versus the standard of care as a second-line treatment in relapsed or refractory large B-cell lymphoma (LBCL)
- Updated data from the primary analysis of the Phase 2 OUTREACH study evaluating Breyanzi as a third-line plus treatment in relapsed or refractory LBCL in the community setting
- Safety and efficacy results of the match-adjusted indirect comparison of the TRANSFORM versus ZUMA-7 studies evaluating Breyanzi versus axicabtagene ciloleucel in the second-line setting in relapsed or refractory LBCL
- Two first disclosures of results from cohorts 2a and 2c of the Phase 2 KarMMa-2 trial evaluating Abecma in high-risk multiple myeloma
- First disclosure of preliminary Phase 1 results for GPRC5D chimeric antigen receptor (CAR) T cell therapy in patients with relapsed/refractory (R/R) multiple myeloma, including patients previously treated with a B-cell maturation antigen (BCMA)-directed CAR T cell therapy
Hematology
- Multiple analyses of Reblozyl® (luspatercept-aamt), including overall survival data from the Phase 3 MEDALIST study in lower-risk myelodysplastic syndromes and real-world, longer-term results from the Phase 2 BEYOND study in beta thalassemia
- Multiple analyses of Inrebic® (fedratinib), including the primary analysis of safety and efficacy from the Phase 3b FREEDOM trial in intermediate- or high-risk myelofibrosis
- Longitudinal analyses of acute myeloid leukemia gene mutations with Onureg® (azacitidine tablets) from the Phase 3 QUAZAR® AML-001 study
Early Pipeline
- First disclosure of preliminary results from the dose escalation and expansion components of the Phase 1 CC-93269 MM-001 study, evaluating subcutaneous bispecific T cell engager alnuctamab in heavily pretreated multiple myeloma
- First results from dose expansion cohort of the CC-92480 Phase 1/2 MM-001 study, evaluating CELMoDTM agent mezigdomide with dexamethasone in patients with R/R multiple myeloma
- Results from post-BCMA cohort of the CC-220 Phase 1/2 MM-001 study, evaluating CELMoD agent iberdomide with dexamethasone in patients with R/R multiple myeloma previously treated with a BCMA-directed therapy
- First results from a Phase 1/2 study evaluating BMS-986158, a potent Bromodomain and Extraterminal (BET) inhibitor, as monotherapy and in combination with ruxolitinib or Inrebic in intermediate- or high-risk myelofibrosis
To learn more about our science and commitment in hematology, check out the BMS at ASH 2022 content hub. You can find additional information about BMS’ presence at the meeting on the ASH website.
Selected Bristol Myers Squibb studies at the 64th ASH Annual Meeting and Exposition include:
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Abstract Title |
Author |
Presentation Type/# |
Session Title |
Session Date/Time (CST) |
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Beta Thalassemia |
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Erythroid Response in Patients with Non-Transfusion-Dependent ß-Thalassemia Treated with Luspatercept: Long-Term Data from the BEYOND Trial |
Ali Taher |
112. Thalassemia and Globin Gene Regulation: Poster III |
Monday, December 12, 6:00 – 8:00 PM |
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Lymphoma |
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Five-Year Results From the Phase 3 Randomized Study AUGMENT: Lenalidomide Plus Rituximab (R2) vs Rituximab Plus Placebo in Patients with Relapsed/Refractory Indolent Non-Hodgkin Lymphoma |
John Leonard |
623. Mantle Cell, Follicular, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological III |
Saturday, December 10, 2:15 PM |
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Iberdomide (CC-220) Monotherapy or in Combination with an Anti-CD20 Monoclonal Antibody as Effective Therapy in Patients with Relapsed/Refractory Lymphoma: Early Results from a Phase 1/2 Study |
Catherine Thieblemont |
623. Mantle Cell, Follicular, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological III |
Saturday, December 10, 3:00 PM |
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Lisocabtagene Maraleucel (liso-cel) versus Standard of Care (SOC) with Salvage Chemotherapy Followed by Autologous Stem Cell Transplantation (ASCT) as Second-line (2L) Treatment in Patients with Relapsed or Refractory Large B-Cell Lymphoma (LBCL): Primary Analysis of the Randomized, Phase 3 TRANSFORM Study |
Jeremy Abramson |
705. Cellular Immunotherapies: Results from CD19-Directed CAR T in treating Aggressive B-cell Lymphomas |
Sunday, December 11, 4:30 PM
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Matching-Adjusted Indirect Comparison (MAIC) of Lisocabtagene Maraleucel (Liso-cel) Versus Axicabtagene Ciloleucel (Axi-cel) for Second-line (2L) Treatment of Patients with Refractory/Early Relapsed (R/R) Large B-Cell Lymphoma (LBCL) |
Jeremy Abramson
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705. Cellular Immunotherapies: Late Phase and Commercially Available Therapies: Poster I |
Saturday December 10, 5:30 – 7:30 PM |
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Real-World Treatment Patterns and Costs of Chimeric Antigen Receptor (CAR) T Cell Therapies (CAR T), Polatuzumab Vedotin-piiq (pola), and Tafasitamab-cxix (tafa) in Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) |
Fei Fei Liu |
905. Outcomes Research—Lymphoid Malignancies: Health Outcomes in CAR T and Stem Cell Transplantation |
Monday, December 12, 5:00 PM |
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Results from OUTREACH: A Phase 2 Study of Lisocabtagene Maraleucel (Liso-cel) Administered as Outpatient (Outpt) or Inpatient (Inpt) Treatment in the Community/Nonuniversity Setting in Patients (Pts) with Relapsed or Refractory (R/R) Large B-Cell Lymphoma (LBCL) |
Yuliya Linhares |
705. Cellular Immunotherapies: Late Phase and Commercially Available Therapies: Poster III |
Monday, December 12, 6:00 – 8:00 PM |
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Multiple Myeloma |
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Alnuctamab (BMS-986349; CC-93269), a B-cell Maturation Antigen (BCMA) x CD3 2+1 T cell Engager (TCE), in Patients (pts) with Relapsed/Refractory Multiple Myeloma (RRMM): Results from a Phase 1 First-in-Human Clinical Study |
Sandy W. Wong |
653. Myeloma and Plasma Cell Dyscrasias: Prospective Therapeutic Trials: Bispecific Monoclonal Antibodies in Myeloma |
Saturday, December 10, 1:15 PM |
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KarMMa-2 Cohort 2a: Efficacy and Safety of Idecabtagene Vicleucel in Clinical High-risk Multiple Myeloma Patients with Early Relapse After Frontline Autologous Stem Cell Transplantation |
Saad Usmani
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704. Cellular Immunotherapies: Early Phase and Investigational Therapies: CAR T in Multiple Myeloma and T-cell Therapies After Allo-HCT |
Saturday, December 10, 4:00 PM |
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Clinical Activity of BMS-986393 (CC-95266), a G Protein–Coupled Receptor Class C Group 5 Member D (GPRC5D)–Targeted Chimeric Antigen Receptor (CAR) T Cell Therapy, in Patients With Relapsed and/or Refractory (R/R) Multiple Myeloma (MM): First Results From a Phase 1, Multicenter, Open-Label Study |
Susan Bal |
704. Cellular Immunotherapies: Early Phase and Investigational Therapies: CAR T in Multiple Myeloma and T-cell Therapies After Allo-HCT |
Saturday, December 10, 4:45 PM |
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Iberdomide (IBER) in Combination with Dexamethasone (DEX) in Relapsed/Refractory Multiple Myeloma (RRMM): Results from the Anti-B-Cell Maturation Antigen (BCMA)-Exposed Cohort of the CC-220-MM-001 Trial |
Sagar Lonial |
653. Myeloma and Plasma Cell Dyscrasias: Prospective Therapeutic Trials: Poster I |
Saturday, December 10, 5:30 – 7:30 PM |
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Results From the First Phase 1 Clinical Study of the B-cell Maturation Antigen (BCMA) NEX-T Chimeric Antigen Receptor (CAR) T Cell Therapy CC-98633/BMS-986354 in Patients (pts) with Relapsed/Refractory Multiple Myeloma (RRMM) |
Luciano Megala Costa |
653. Myeloma and Plasma Cell Dyscrasias: Prospective Therapeutic Trials: Novel Drugs and Optimized Approaches in Myeloma |
Sunday, December 11, 12:15 PM |
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Mezigdomide (CC-92480), a Potent, Novel Cereblon E3 Ligase Modulator (CELMoD), Combined with Dexamethasone (DEX) in Patients (pts) with Relapsed/Refractory Multiple Myeloma (RRMM): Preliminary Results from the Dose-Expansion Phase of the CC-92480-MM-001 Trial |
Paul Richardson |
653. Myeloma and Plasma Cell Dyscrasias: Prospective Therapeutic Trials: Novel Drugs and Optimized Approaches in Myeloma |
Sunday, December 11, 12:45 PM |
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KarMMa-2 Cohort 2c: Efficacy and Safety of Idecabtagene Vicleucel in Patients with Clinical High-risk Multiple Myeloma due to Inadequate Response to Frontline Autologous Stem Cell Transplantation |
Madhav Dhodapkar
|
704. Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster II |
Sunday, December 11, 6:00 – 8:00 PM |
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Myelodysplastic Syndromes |
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Real-World Outcomes of Patients with Lower-Risk Myelodysplastic Syndromes (LR-MDS) Treated with Luspatercept: an Evaluation of US Clinical Practice Utilization and Treatment Patterns |
Sudipto Mukherjee |
906. Outcomes Research—Myeloid Malignancies I |
Saturday, December 10, 5:00 PM |
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Multiple Episodes of Transfusion Independence with Luspatercept Treatment and the Impact of Dose Escalation in Patients with Lower-Risk Myelodysplastic Syndromes from the MEDALIST Study |
Uwe Platzbecker |
637. Myelodysplastic Syndromes – Clinical and Epidemiological: Poster II |
Sunday, December 11, 6:00 – 8:00 PM |
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Overall Survival and Progression-Free Survival of Patients Following Luspatercept Treatment in the MEDALIST Trial |
Valeria Santini |
637. Myelodysplastic Syndromes – Clinical and Epidemiological: Poster I |
Sunday, December 11, 5:30 – 7:30 PM |
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Myelofibrosis |
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Safety and Efficacy of Fedratinib in Patients with Primary (P), Post-Polycythemia Vera (post-PV), and Post-Essential Thrombocythemia (Post-ET) Myelofibrosis (MF) Previously Treated with Ruxolitinib: Primary Analysis of the FREEDOM Trial |
Vikas Gupta |
634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster I |
Saturday, December 10, 5:30 – 7:30 PM |
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BMS-986158, a Potent BET Inhibitor, As Monotherapy and in Combination with Ruxolitinib or Fedratinib in Intermediate- or High-Risk Myelofibrosis: First Results from a Phase 1/2 Study |
Rosa Ayala |
634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster III |
Monday, December 12, 6:00 – 8:00 PM |
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Bristol Myers Squibb: Creating a Better Future for Cancer Patients
Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine, and through innovative digital platforms, are turning data into insights that sharpen their focus. Deep scientific expertise, cutting-edge capabilities and discovery platforms enable the company to look at cancer from every angle. Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. Because as a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.
BREYANZI U.S. INDICATION
Breyanzi is a CD-19 directed chimeric antigen receptor (CAR) T cell therapy, administered as a defined composition to reduce variability of the CD8 and CD4 component dose. Breyanzi has a 4-1BB costimulatory domain which enhances the expansion and persistence of the CAR T cells. Breyanzi was previously approved by the U.S. Food and Drug Administration for the treatment of adult patients with relapsed or refractory LBCL after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B. Breyanzi is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the BREYANZI REMS.
Breyanzi is also approved in Europe, Switzerland, Canada and Japan for relapsed and refractory LBCL after two or more lines of systemic therapy. Bristol Myers Squibb’s clinical development program for Breyanzi includes clinical studies in earlier lines of treatment for patients with relapsed or refractory LBCL and other types of lymphoma. For more information, visit clinicaltrials.gov.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITIES
- 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.
- 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. Among patients receiving BREYANZI for LBCL (N=418), CRS occur in 46% (190/418) of patients, including ≥ Grade 3 CRS (Lee grading system) in 3.1% of patients.
In patients receiving BREYANZI after two or more lines of therapy for LBCL, CRS occurred in 46% (122/268), including ≥ Grade 3 CRS in 4.1% of patients. One patient had fatal CRS and 2 had ongoing CRS at time of death. The median time to onset was 5 days (range: 1 to 15 days). CRS resolved in 98% with a median duration of 5 days (range: 1 to 17 days).
In patients receiving BREYANZI after one line of therapy for LBCL, CRS occurred in 45% (68/150), including Grade 3 CRS in 1.3% of patients. The median time to onset was 4 days (range: 1 to 63 days). CRS resolved in all patients with a median duration of 4 days (range: 1 to 16 days).
The most common manifestations of CRS (≥10%) included fever (94%), hypotension (42%), tachycardia (28%), chills (23%), hypoxia (16%), and headache (12%).
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.
Of the 418 patients who received BREYANZI for LBCL, 23% received tocilizumab and/or a corticosteroid for CRS, including 10% who received tocilizumab only and 2.2% who received corticosteroids only.
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 patients receiving BREYANZI after two or more lines of therapy for LBCL, CAR T cell-associated neurologic toxicities occurred in 35% (95/268), including ≥ Grade 3 in 12% of patients. Three patients had fatal neurologic toxicity and 7 had ongoing neurologic toxicity at time of death. The median time to onset of neurotoxicity was 8 days (range: 1 to 46 days). Neurologic toxicities resolved in 85% with a median duration of 12 days (range: 1 to 87 days).
In patients receiving BREYANZI after one line of therapy for LBCL, CAR T cell-associated neurologic toxicities occurred in 27% (41/150) of patients, including Grade 3 cases in 7% of patients. The median time to onset of neurologic toxicities was 8 days (range: 1 to 63 days). The median duration of neurologic toxicity was 6 days (range: 1 to 119 days).
In all patients combined receiving BREYANZI for LBCL, neurologic toxicities occurred in 33% (136/418), including ≥ Grade 3 cases in 10% of patients. The median time to onset was 8 days (range: 1 to 63), with 87% of cases developing by 16 days. Neurologic toxicities resolved in 85% of patients with a median duration of 11 days (range: 1 to 119 days). Of patients developing neurotoxicity, 77% (105/136) also developed CRS.
The most common neurologic toxicities (≥ 5%) included encephalopathy (20%), tremor (13%), aphasia (8%), headache (6%), dizziness (6%), and delirium (5%).
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.
- Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense, or administer BREYANZI are trained on the management of CRS and neurologic toxicities.
Further information is available at www.BreyanziREMS.com, or contact Bristol-Myers Squibb at 1-888-423-5436.
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 patients receiving BREYANZI for LBCL, infections of any grade occurred in 36% 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 occurred in 4.3%, viral infections in 1.9% and fungal infections in 0.5%.
Febrile neutropenia developed after BREYANZI infusion in 8% of patients with LBCL. 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 patients who received BREYANZI for LBCL, 15 of the 16 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.
Grade 3 or higher cytopenias persisted at Day 29 following BREYANZI infusion in 36% of patients with LBCL, and included thrombocytopenia in 28%, neutropenia in 21%, and anemia in 6%.
Monitor complete blood counts prior to and after BREYANZI administration.
Hypogammaglobulinemia
B-cell aplasia and hypogammaglobulinemia can occur in patients receiving treatment with BREYANZI.
In patients receiving BREYANZI for LBCL, hypogammaglobulinemia was reported as an adverse reaction in 11% of patients. Hypogammaglobulinemia, either as an adverse reaction or laboratory IgG level below 500 mg/dL after infusion, was reported in 28% 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.
Contacts
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