First presentation of results from primary analysis of Phase 2 TRANSCEND FL study evaluating second-line treatment with Breyanzi® (lisocabtagene maraleucel; liso-cel) in relapsed or refractory follicular lymphoma demonstrate its potential best-in-class and best-in-disease profile
Multiple new analyses of the Phase 3 KarMMa-3 study of Abecma® (idecabtagene vicleucel) in triple-class exposed relapsed and refractory multiple myeloma in earlier lines of therapy, including longer-term progression-free survival data and clinically meaningful improvements in patient-reported outcomes
New data from the Phase 3 COMMANDS study evaluating Reblozyl® (luspatercept-aamt), including results from the primary analysis and patient-reported outcomes, reinforce Reblozyl’s clinical benefit in erythropoiesis stimulating agent-naïve, myelodysplastic syndromes-related anemia
New results highlighting the enhanced immune-stimulating activity and combinability of targeted protein degradation agents in the treatment of relapsed or refractory multiple myeloma and non-Hodgkin's lymphoma, including diffuse large B-cell lymphoma
Updated safety and efficacy data from the Phase 1 study of GPRC5D CAR T (BMS-986393/CC-95266) in patients with relapsed or refractory multiple myeloma, including in patients with prior BCMA-directed therapy
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced the presentation of research across its hematology and cell therapy portfolio and pipeline at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition, which will take place in San Diego, California from December 9 to 12, 2023. Results from 73 data disclosures across company-sponsored studies will be featured, including 22 oral presentations, showcasing BMS’ commitment to delivering transformative medicines that help more patients living with blood disorders.
“At this year’s ASH meeting, we look forward to highlighting our continued commitment to unlocking the full promise of cell therapy and our differentiated research platforms, demonstrating the clinical and real-world value of our medicines through our scientific innovation,” said Samit Hirawat, M.D., executive vice president, chief medical officer, Global Drug Development, Bristol Myers Squibb. “New data from our diverse portfolio, spanning multiple platforms and combinations, reinforce our pursuit of the next wave of hematology advances across a spectrum of blood diseases with the highest unmet needs.”
Key data being presented by Bristol Myers Squibb and its partners at the 2023 ASH Annual Meeting and Exposition include:
Cell Therapy
Targeted Protein Degradation
Additional Novel Treatment Modalities
You can find additional information about BMS’ presence at the meeting on the ASH website.
Selected Bristol Myers Squibb studies at the 65th ASH Annual Meeting and Exposition include:
Abstract Title | Author | Presentation Type/# | Session Title | Session Date/Time (PST) |
Beta Thalassemia | ||||
Improvement of Underlying Disease Pathophysiology of Ineffective Erythropoiesis in Non-Transfusion-Dependent (NTD) Patients with Beta-Thalassemia Receiving Luspatercept: Biomarker Analysis from the BEYOND Trial | Manuel Ugidos Guerrero | 112. Thalassemia and Globin Gene Regulation: Poster III
| Saturday, December 9, 5:30 - 7:30 PM | |
Real-World Characteristics, Treatment Utilization, and Transfusion Burden in Patients with β-Thalassemia Initiating Luspatercept: A US Cohort Study | Sujit Sheth | 112. Thalassemia and Globin Gene Regulation: Poster II | Sunday, December 10, 6:00 - 8:00 PM | |
Durable Symptom Improvement for Patients with Non-Transfusion Dependent Thalassemia Treated with Luspatercept: Patient-Reported Outcomes from the BEYOND Study | Khaled Musallam | 112. Thalassemia and Globin Gene Regulation: Poster II | Sunday, December 10, 6:00 - 8:00 PM | |
Efficacy and Safety of Luspatercept in Patients Enrolled in the BELIEVE Trial: Data from the Phase 3b Long-Term Rollover Study | Maria Cappellini | 112. Thalassemia and Globin Gene Regulation: Poster III | Monday, December 11, 6:00 - 8:00 PM | |
Luspatercept for the Treatment of Anemia in Non-Transfusion-Dependent β-Thalassemia: Final Safety and Efficacy Data from the BEYOND Trial | Ali Taher | 112. Thalassemia and Globin Gene Regulation: Poster III | Monday, December 11, 6:00 - 8:00 PM | |
Efficacy and Safety of Luspatercept in Patients with HbE/β‑Thalassemia from the BELIEVE Study: a Subgroup Analysis | Kevin Kuo | 112. Thalassemia and Globin Gene Regulation: Poster III | Monday, December 11, 6:00 - 8:00 PM | |
Leukemia | ||||
Lisocabtagene Maraleucel (liso-cel) in R/R CLL/SLL: 24-Month Median Follow-up of TRANSCEND CLL 004 | Tanya Siddiqi | 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: New Inhibitors and Cellular Therapies for Treatment of Relapsed CLL | Saturday, December 9, 5:15 PM | |
The Total Lifetime Cost of Treating Patients (Pts) with CLL in the United States (US) | Farrukh Awan
| 902. Health Services and Quality Improvement – Lymphoid Malignancies: Poster I | Saturday, December 9, 5:30 - 7:30 PM | |
Undetectable MRD Status in Patients with R/R CLL/SLL with Stable Disease After Lisocabtagene Maraleucel Treatment: Exploratory Analysis of the TRANSCEND CLL 004 Study | Eniko Papp | 641. Chronic Lymphocytic Leukemias: Basic and Translational: Poster II
| Sunday, December 10, 6:00 - 8:00 PM | |
Lymphoma | ||||
Multicenter, Real-world Study in Patients with R/R Large B-Cell Lymphoma (LBCL) Who Received Lisocabtagene Maraleucel (liso-cel) in the United States (US) | Jennifer Crombie | 705. Cellular Immunotherapies: Late Phase and Commercially Available Therapies: Cellular Therapy for B Cell Lymphomas: Prospective Clinical Trials and Real World Data | Saturday, December 9, 9:45 AM | |
Lisocabtagene Maraleucel as Second-Line Therapy for R/R Large B-Cell Lymphoma in Patients Not Intended for Hematopoietic Stem Cell Transplant: Final Analysis of the Phase 2 PILOT Study | Alison Sehgal | 705. Cellular Immunotherapies: Late Phase and Commercially Available Therapies: Cellular Therapy for B Cell Lymphomas: Prospective Clinical Trials and Real World Data | Saturday, December 9, 10:00 AM | |
Circulating Tumor DNA Dynamics as Early Outcome Predictors for Lisocabtagene Maraleucel as Second-Line Therapy for Large B-Cell Lymphoma from the Phase 3 TRANSFORM Study | Lara Stepan | 705. Cellular Immunotherapies: Late Phase and Commercially Available Therapies: Translational Data and Prognostic Factors | Saturday, December 9, 2:30 PM | |
Pharmacodynamic Biomarkers and CtDNA Support the Mechanism of Action and Clinical Efficacy of Golcadomide (CC-99282) Combined with R-CHOP in Previously Untreated Aggressive B-Cell Lymphoma | Mark Kaplan | 621. Lymphomas: Translational – Molecular and Genetic: Poster I
| Saturday, December 9, 5:30 - 7:30 PM | |
Postinfusion Monitoring Health Care Resource Utilization and Costs by Site of Care Among Inpatients and Outpatients with Relapsed or Refractory Large B-Cell Lymphoma who Received Second-Line Treatment with Lisocabtagene Maraleucel in the TRANSFORM and PILOT Clinical Trials | November McGarvey | 902. Health Services and Quality Improvement – Lymphoid Malignancies: Poster I
| Saturday, December 9, 5:30 - 7:30 PM | |
Matching-Adjusted Indirect Comparison (MAIC) of Efficacy and Safety of Lisocabtagene Maraleucel (liso-cel) and Mosunetuzumab for the Treatment (Tx) of Third Line or Later (3L+) Relapsed or Refractory (R/R) Follicular Lymphoma (FL) | Loretta Nastoupil | 902. Health Services and Quality Improvement – Lymphoid Malignancies: Poster I
| Saturday, December 9, 5:30 - 7:30 PM | |
Patient-Reported Outcomes from the MCL Cohort of the Phase 1, Seamless Design TRANSCEND NHL 001 Study of Lisocabtagene Maraleucel in Patients with R/R B-Cell NHL | Michael Wang | 905. Outcomes Research – Lymphoid Malignancies: Patient Reported Outcomes in Hematological Malignancies | Sunday, December 10, 4:30 PM | |
TRANSCEND FL: Phase 2 Study Primary Analysis Results of Lisocabtagene Maraleucel in Patients with Second-Line High-risk Relapsed or Refractory Follicular Lymphoma | Franck Morschhauser | 623. Mantle Cell, Follicular, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Immunotherapy | Sunday, December 10, 4:45 PM | |
Patient-Reported Outcomes from the Phase 2 TRANSCEND FL Study of Lisocabtagene Maraleucel in Patients with Relapsed or Refractory Indolent B-Cell Non-Hodgkin Lymphoma | Guillaume Cartron | 905. Outcomes Research – Lymphoid Malignancies: Patient Reported Outcomes in Hematological Malignancies | Sunday, December 10, 4:45 PM | |
Lisocabtagene Maraleucel (liso-cel) in Patients (Pts) with R/R MCL: Subgroup Analyses in Pts with High-Risk Disease Features from the MCL Cohort of the TRANSCEND NHL 001 Study | Maria Lia Palomba | 705. Cellular Immunotherapies: Late Phase and Commercially Available Therapies: Poster II | Sunday, December 10, 6:00 - 8:00 PM | |
Cytokine Release Syndrome and Neurological Event Management Resource Use and Costs Among Patients with Relapsed or Refractory Large B-Cell Lymphoma Who Received Second-Line Lisocabtagene Maraleucel Treatment in TRANSFORM and PILOT | November McGarvey
| 902. Health Services and Quality Improvement - Lymphoid Malignancies: Poster II
| Sunday, December 10, 6:00 - 8:00 PM | |
Golcadomide (GOLCA; CC-99282), a Novel CELMoD Agent, Plus R-CHOP in Patients (pts) with Previously Untreated Aggressive B-Cell Lymphoma (a-BCL): Safety and Efficacy Results from Phase 1b Dose Expansion | Marc Hoffmann | 626. Aggressive Lymphomas: Prospective Therapeutic Trials: Poster III
| Monday, December 11, 6:00 - 8:00 PM | |
Efficacy and Safety of Golcadomide, a Novel Cereblon E3 Ligase Modulator (CELMoD) Agent, Combined with Rituximab in a Phase 1/2 Open-Label Study of Patients with Relapsed/Refractory Non-Hodgkin Lymphoma | Julio Chavez | 627. Aggressive Lymphomas: Clinical and Epidemiological: Poster III
| Monday, December 11, 6:00 - 8:00 PM | |
Estimation of Postinfusion Resource Use and Total Costs of Care for Patients with R/R Follicular Lymphoma (FL) Receiving Lisocabtagene Maraleucel (liso-cel) in the TRANSCEND FL Study | Ashley Saunders | 902. Health Services and Quality Improvement - Lymphoid Malignancies: Poster III | Monday, December 11, 6:00 - 8:00 PM | |
Multiple Myeloma | ||||
Effects of Idecabtagene Vicleucel (Ide-Cel) Versus Standard Regimens on Health-Related Quality of Life (HRQoL) in Patients with Relapsed/Refractory Multiple Myeloma (RRMM) Who Had Received 2–4 Prior Regimens: Updated Results from the Phase 3 KarMMa-3 Trial | Michele Delforge | 652. Multiple Myeloma: Clinical and Epidemiological: T Cell Redirecting Therapy Outcomes and Associated Complications | Saturday, December 9, 10:45 AM | |
BMS-986393 (CC-95266), a G protein–Coupled Receptor Class C Group 5 Member D (GPRC5D)–Targeted Chimeric Antigen Receptor (CAR) T-Cell Therapy for Relapsed/Refractory Multiple Myeloma (RRMM): Updated Results from a Phase 1 Study | Susan Bal | 704. Cellular Immunotherapies: Early Phase and Investigational Therapies: Expanding Disease Targets for CAR-T Cell Therapies | Saturday, December 9, 2:30 PM | |
Mezigdomide reverses T-Cell exhaustion through degradation of Aiolos/Ikaros and Reinvigoration of cytokine production pathways | Hsiling Chiu | 651. Multiple Myeloma and Plasma Cell Dyscrasias: Basic and Translational: Characterization of the MM and the Tumor Microenvironment | Saturday, December 9, 5:00 PM | |
Alnuctamab (ALNUC; BMS-986349; CC-93269), a 2+1 B-Cell Maturation Antigen (BCMA) × CD3 T-Cell Engager (TCE), Administered Subcutaneously (SC) in Patients (Pts) with Relapsed/Refractory Multiple Myeloma (RRMM): Updated Results from a Phase 1 First‑in‑Human Clinical Study | Noffar Bar | 653. Multiple Myeloma: Prospective Therapeutic Trials: Poster I
| Saturday, December 9, 5:30 - 7:30 PM | |
Efficacy and Safety of Idecabtagene Vicleucel (ide-cel) in Patients with Clinical High-Risk Newly Diagnosed Multiple Myeloma (MM) with an Inadequate Response to Frontline Autologous Stem Cell Transplantation (ASCT): KarMMa-2 Cohort 2c Extended Follow-up | Madhav Dhodapkar | 704. Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster I | Saturday, December 9, 5:30 - 7:30 PM | |
Patient (pt) Experiences of Receiving Idecabtagene Vicleucel (Ide-Cel, bb2121) Versus Standard (Std) Regimens for the Treatment (Tx) of Relapsed/Refractory Multiple Myeloma (RRMM) in the Randomized, Controlled KarMMa-3 Clinical Trial: Analysis of Longitudinal Qualitative Interviews | Paula Rodriguez Otero | 905. Outcomes Research – Lymphoid Malignancies: Poster I
| Saturday, December 9, 5:30 - 7:30 PM | |
Preclinical and Translational Biomarker Analyses to Inform Clinical Development of Mezigdomide (CC-92480) in Combination with Dexamethasone and Daratumumab in Multiple Myeloma | Tracy Chow | 651. Multiple Myeloma and Plasma Cell Dyscrasias: Basic and Translational: Poster II | Sunday, December 10, 6:00 - 8:00 PM | |
Healthcare Resource Utilization and Economic Burden of Cytokine Release Syndrome and Neurotoxicity in Patients with Relapsed and Refractory Multiple Myeloma (RRMM) Receiving Idecabtagene Vicleucel in Earlier-Line Settings in the KarMMa-3 Clinical Trial | Sikander Ailawadhi | 905. Outcomes Research—Lymphoid Malignancies: Poster II
| Sunday, December 10, 6:00 - 8:00 PM | |
Clinical Outcomes in Real-World Patients (RW) with Triple-Class Exposed (TCE) Relapsed/Refractory Multiple Myeloma (RRMM): A Retrospective Study using Electronic Health Records from Flatiron Health and COTA Vantage Databases | Hans C Lee | 905. Outcomes Research—Lymphoid Malignancies: Poster II
| Sunday, December 10, 6:00 - 8:00 PM | |
Treatment Patterns and Outcomes for Patients with Newly Diagnosed Multiple Myeloma Post-Stem Cell Transplantation Who Received Lenalidomide As First Line Maintenance Therapy (PREAMBLE) | Ravi Vij | 905. Outcomes Research—Lymphoid Malignancies: Poster II
| Sunday, December 10, 6:00 - 8:00 PM | |
Effects of Idecabtagene Vicleucel (Ide-Cel) Versus Standard Regimens on Health-Related Quality of Life (HRQoL) in Patients with Triple-Class-Exposed (TCE) Relapsed/Refractory Multiple Myeloma (RRMM) Who Received at Least 3 Lines of Prior Antimyeloma Regimens in the KarMMa-3 Phase 3 Randomized Controlled Trial | Michele Delforge | 652. Multiple Myeloma: Clinical and Epidemiological: Predicting Outcome and Side Effects of Novel Immunotherapies in Multiple Myeloma | Monday, December 11, 4:30 PM | |
A Pro-Inflammatory State and Peak Cytokines Are Associated with Toxicity and Early Responses in Real-World Multiple Myeloma Patients Treated with Idecabtagene Vicleucel | Doris Hansen | 652. Multiple Myeloma: Clinical and Epidemiological: Predicting Outcome and Side Effects of Novel Immunotherapies in Multiple Myeloma | Monday, December 11, 4:45 PM | |
Idecabtagene Vicleucel (ide-cel) Versus Standard Regimens in Patients (pts) with Triple-Class Exposed (TCE) Relapsed and Refractory Multiple Myeloma (RRMM): Updated Analysis from KarMMa-3 | Paula Rodriguez-Otero | 705. Cellular Immunotherapies: Late Phase and Commercially Available Therapies: Cellular Therapy for Multiple Myeloma, B-cell Acute Lymphoblastic Leukemia and B Cell Lymphomas: Clinical Trial and Real World Evidence | Monday, December 11, 4:45 PM | |
Mezigdomide (MEZI) Plus Dexamethasone (DEX) and Daratumumab (DARA) or Elotuzumab (ELO) in Patients (pts) with Relapsed/Refractory Multiple Myeloma (RRMM): Results from the CC-92480-MM-002 Trial | Paul Richardson | 653. Multiple Myeloma: Prospective Therapeutic Trials: Relapsed and Refractory Myeloma | Monday, December 11, 5:30 PM | |
RRMM and Post-BCMA Treated Subjects from the CC-220-MM-001 Study Show Increased Genomic Aberrations Associated with High-Risk and Significant Dysfunction in CD4+ T-Cell Compartment Compared to NDMM Subjects | Michael Amatangelo | 651. Multiple Myeloma and Plasma Cell Dyscrasias: Basic and Translational: Poster III
| Monday, December 11, 6:00 - 8:00 PM | |
Idecabtagene Vicleucel (Ide-cel) versus Standard (std) Regimens in Patients With Triple-Class–Exposed (TCE) Relapsed and Refractory Multiple Myeloma (RRMM): Analysis of Cytopenias and Infections in Patients (pts) From KarMMa-3 | Rachid Baz | 705. Cellular Immunotherapies: Late Phase and Commercially Available Therapies: Poster III | Monday, December 11, 6:00 - 8:00 PM | |
Facility-Related Healthcare Resource Utilization (HCRU) for Patients Treated with Idecabtagene Vicleucel (Ide-Cel, bb2121) in a Real-World (RW) Setting: A Single-Center Experience | Lauren Peres | 902. Health Services and Quality Improvement - Lymphoid Malignancies: Poster III | Monday, December 11, 6:00 - 8:00 PM | |
Myelodysplastic Syndromes | ||||
Efficacy and Safety of Luspatercept Versus Epoetin Alfa in Erythropoiesis-Stimulating Agent (ESA)-Naive Patients (Pts) with Transfusion-Dependent (TD) Lower-Risk Myelodysplastic Syndromes (LR-MDS): Full Analysis of the COMMANDS Trial | Guillermo Garcia-Manero | 637. Myelodysplastic Syndromes – Clinical and Epidemiological: Treatment Options and Decision Making in Low Risk MDS | Saturday, December 9, 2:00 PM | |
GDF11/SMAD Regulated Splicing of GATA1 Is Associated with Response to Luspatercept in Lower-Risk Myelodysplastic Syndromes (LR MDS) | Srinivas Aluri | 636. Myelodysplastic Syndromes – Basic and Translational: Molecular Drivers and Therapeutic Implications | Saturday, December 9, 5:15 PM | |
Luspatercept Modulates Inflammation in the Bone Marrow, Restores Effective Erythropoiesis/Hematopoiesis, and Provides Sustained Clinical Benefit versus Epoetin Alfa (EA): Biomarker Analysis from the Phase 3 COMMANDS Study | Sheida Hayati | 636. Myelodysplastic Syndromes – Basic and Translational: Poster I
| Saturday, December 9, 5:30 - 7:30 PM | |
Clonal Hematopoiesis-Related Mutations Are Associated with Favorable Clinical Benefit Following Luspatercept Treatment in Patients with Lower-Risk Myelodysplastic Syndromes: A Subgroup Analysis from the Phase 3 COMMANDS Trial | Maroof Hasan | 636. Myelodysplastic Syndromes—Basic and Translational: Poster II
| Sunday, December 10, 6:00 - 8:00 PM | |
Real-World Retrospective Study of Non-Transfusion Dependent Patients with Myelodysplastic Syndromes in a Large Healthcare Claims Database | Leslie Andritsos | 906. Outcomes Research—Myeloid Malignancies: Poster II | Sunday, December 10, 6:00 - 8:00 PM | |
Long-Term Evaluation of Luspatercept in Erythropoiesis Stimulating Agent (ESA)-Intolerant/Refractory Patients (pts) with Lower-Risk Myelodysplastic Syndromes (LR-MDS) in the Phase 3 MEDALIST Study | Valeria Santini | 906. Outcomes Research – Myeloid Malignancies: Symptom Burden and Supportive Therapies | Monday, December 11, 3:15 PM | |
Real-World Impact of Luspatercept on Patients with Myelodysplastic Syndromes Requiring Red Blood Cell Transfusions and with Prior Exposure to Erythropoietin Stimulating Agents in a Large Healthcare Claims Database | Kashyap Patel | 906. Outcomes Research – Myeloid Malignancies: Symptom Burden and Supportive Therapies | Monday, December 11, 3:30 PM | |
Patient-Reported Outcomes (PRO) of Luspatercept Versus Epoetin Alfa in Erythropoiesis-Stimulating Agent (ESA)-Naïve, Transfusion-Dependent (TD), Low-Risk Myelodysplastic Syndromes (MDS): Results from the Phase 3 COMMANDS Study | Esther Oliva | 637. Myelodysplastic Syndromes – Clinical and Epidemiological: Poster III
| Monday, December 11, 6:00 - 8:00 PM | |
Impact of Genomic Landscape and Mutational Burden on Primary Endpoint Responses in the COMMANDS Study | Rami Komrokji | 636. Myelodysplastic Syndromes—Basic and Translational: Poster III | Monday, December 11, 6:00 - 8:00 PM | |
Myelofibrosis | ||||
Patient Characteristics, Treatment Patterns, and Health Outcomes in a Real-World Population of Patients with Myelofibrosis Treated with Fedratinib | Francesco Passamonti
| 906. Outcomes Research – Myeloid Malignancies: Poster I | Saturday, December 9, 5:30 - 7:30 PM | |
BMS-986158, a Potent BET Inhibitor, in Combination with Ruxolitinib or Fedratinib in Patients (pts) with Intermediate- or High-risk Myelofibrosis (MF): Updated Results from a Phase 1/2 Study | David Lavie | 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Charting the Future of MPN Therapies | Sunday, December 10, 5:30 PM | |
Modulation of Biomarkers by BET Inhibitor, BMS-986158, Including JAK2 Variant Allele Frequency (VAF), Bone Marrow (BM) Fibrosis, and Reversal of Abnormal Cytokine Production in Intermediate- or High-Risk Myelofibrosis (MF) | Si Tuen Lee-Hoeflich | 631. Myeloproliferative Syndromes and Chronic Myeloid Leukemia: Basic and Translational: Poster II | Sunday, December 10, 6:00 - 8:00 PM | |
Efficacy and Safety of Fedratinib in Patients with Myelofibrosis Previously Treated with Ruxolitinib: Results from the Phase 3 Randomized FREEDOM2 Study | Claire Harrison | 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster II | Sunday, December 10, 6:00 - 8:00 PM | |
Fedratinib Treatment Reduces the Inflammatory Cytokine Profile and Decreases Exhausted T Cells Correlating with Clinical Response in Patients with Myelofibrosis: Biomarker Analysis from the Phase 3 FREEDOM2 Trial | Danny Jeyaraju | 631. Myeloproliferative Syndromes and Chronic Myeloid Leukemia: Basic and Translational: Poster III | Monday, December 11, 6:00 - 8:00 PM | |
Clinical Parameters, Anemia, and Spleen Response in Patients with MF-Related Anemia Treated with Luspatercept: Efficacy Sub-Analysis from the ACE-536-MF-001 Study | Aaron Gerds | 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster III | Monday, December 11, 6:00 - 8:00 PM |
BREYANZIU.S.INDICATIONS
BREYANZI® (lisocabtagene maraleucel; liso-cel) is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with large B-cell lymphoma (LBCL), 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, who have:
Limitations of Use: BREYANZI is not indicated for the treatment of patients with primary central nervous system lymphoma.
Important Safety Information
BOXED WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITIES
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 occurred in 46% (190/418), 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:
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 infusions.
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. 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. 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.
Effects on Ability to Drive and Use Machines
Due to the potential for neurologic events, including altered mental status or seizures, patients receiving BREYANZI are at risk for developing altered or decreased consciousness or impaired coordination in the 8 weeks following BREYANZI administration. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, for at least 8 weeks.
Adverse Reactions
The most common nonlaboratory adverse reactions (incidence ≥ 30%) are fever, CRS, fatigue, musculoskeletal pain, and nausea.
The most common Grade 3-4 laboratory abnormalities (≥ 30%) include lymphocyte count decrease, neutrophil count decrease, platelet count decrease, and hemoglobin decrease.
Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide.
ABECMA U.S.INDICATION
ABECMA® (idecabtagene vicleucel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, AND PROLONGED CYTOPENIA
Warnings and Precautions:
Cytokine Release Syndrome (CRS): CRS, including fatal or life-threatening reactions, occurred following treatment with ABECMA in 85% (108/127) of patients. Grade 3 or higher CRS occurred in 9% (12/127) of patients, with Grade 5 CRS reported in one (0.8%) patient. The median time to onset of CRS, any grade, was 1 day (range: 1 - 23 days) and the median duration of CRS was 7 days (range: 1 - 63 days). The most common manifestations included pyrexia, hypotension, tachycardia, chills, hypoxia, fatigue, and headache. Grade 3 or higher events that may be associated with CRS include hypotension, hypoxia, hyperbilirubinemia, hypofibrinogenemia, acute respiratory distress syndrome (ARDS), atrial fibrillation, hepatocellular injury, metabolic acidosis, pulmonary edema, multiple organ dysfunction syndrome, and HLH/MAS.
Identify CRS based on clinical presentation. Evaluate for and treat other causes of fever, hypoxia, and hypotension. CRS has been reported to be associated with findings of HLH/MAS, and the physiology of the syndromes may overlap. In patients with progressive symptoms of CRS or refractory CRS despite treatment, evaluate for evidence of HLH/MAS.
Fifty four percent (68/127) of patients received tocilizumab (single dose: 35%; more than 1 dose: 18%). Overall, 15% (19/127) of patients received at least 1 dose of corticosteroids for treatment of CRS. All patients that received corticosteroids for CRS received tocilizumab. Ensure that a minimum of 2 doses of tocilizumab are available prior to infusion of ABECMA.
Monitor patients at least daily for 7 days following ABECMA infusion at the REMS-certified healthcare facility for signs or symptoms of CRS and monitor patients for signs or symptoms of CRS for at least 4 weeks after ABECMA infusion. At the first sign of CRS, institute treatment with supportive care, tocilizumab and/or corticosteroids as indicated.
Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time.
Neurologic Toxicities: Neurologic toxicities, which may be severe or life-threatening, occurred following treatment with ABECMA in 28% (36/127) of patients receiving ABECMA, including Grade 3 in 4% (5/127) of patients. One patient had ongoing Grade 2 neurotoxicity at the time of death. Two patients had ongoing Grade 1 tremor at the time of data cutoff. The median time to onset of neurotoxicity was 2 days (range: 1 - 42 days). CAR T cell-associated neurotoxicity resolved in 92% (33/36) of patients with a median time to resolution of 5 days (range: 1 - 61 days). The median duration of neurotoxicity was 6 days (range: 1 - 578) in all patients including 3 patients with ongoing neurotoxicity. Thirty-four patients with neurotoxicity had CRS with onset in 3 patients before, 29 patients during, and 2 patients after CRS. The most frequently reported manifestations of CAR T cell-associated neurotoxicity include encephalopathy, tremor, aphasia, and delirium. Grade 4 neurotoxicity and cerebral edema in 1 patient, Grade 3 myelitis, and Grade 3 parkinsonism have been reported with ABECMA in another study in multiple myeloma.
Monitor patients at least daily for 7 days following ABECMA infusion at the REMS-certified healthcare facility for signs or symptoms of neurologic toxicities and monitor patients for signs or symptoms of neurologic toxicities for at least 4 weeks after ABECMA infusion and treat promptly. Rule out other causes of neurologic symptoms. Neurologic toxicity should be managed with supportive care and/or corticosteroids as needed.
Counsel patients to seek immediate medical attention should signs or symptoms occur at any time.
Hemophagocytic Lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS): HLH/MAS occurred in 4% (5/127) of patients receiving ABECMA. One patient developed fatal multi-organ HLH/MAS with CRS and another patient developed fatal bronchopulmonary aspergillosis with contributory HLH/MAS. Three cases of Grade 2 HLH/MAS resolved. All events of HLH/MAS had onset within 10 days of receiving ABECMA with a median onset of 7 days (range: 4 - 9 days) and occurred in the setting of ongoing or worsening CRS. Two patients with HLH/MAS had overlapping neurotoxicity. The manifestations of HLH/MAS include hypotension, hypoxia, multiple organ dysfunction, renal dysfunction, and cytopenia. HLH/MAS is a potentially life-threatening condition with a high mortality rate if not recognized early and treated. Treatment of HLH/MAS should be administered per institutional guidelines.
ABECMA REMS: Due to the risk of CRS and neurologic toxicities, ABECMA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ABECMA REMS. Further information is available at www.AbecmaREMS.com or 1-888-423-5436.
Hypersensitivity Reactions: Allergic reactions may occur with the infusion of ABECMA. Serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide (DMSO) in ABECMA.
Infections: ABECMA should not be administered to patients with active infections or inflammatory disorders. Severe, life-threatening, or fatal infections occurred in patients after ABECMA infusion. Infections (all grades) occurred in 70% of patients. Grade 3 or 4 infections occurred in 23% of patients. Overall, 4 patients had Grade 5 infections (3%); 2 patients (1.6%) had Grade 5 events of pneumonia, 1 patient (0.8%) had Grade 5 bronchopulmonary aspergillosis, and 1 patient (0.8%) had cytomegalovirus (CMV) pneumonia associated with Pneumocystis jirovecii. Monitor patients for signs and symptoms of infection before and after ABECMA infusion and treat appropriately. Administer prophylactic, pre-emptive, and/or therapeutic antimicrobials according to standard institutional guidelines.
Febrile neutropenia was observed in 16% (20/127) of patients after ABECMA infusion and 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.
Viral Reactivation: CMV infection resulting in pneumonia and death has occurred following ABECMA administration. Monitor and treat for CMV reactivation in accordance with clinical guidelines. 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 plasma cells. Perform screening for CMV, HBV, hepatitis C virus (HCV), and human immunodeficiency virus (HIV) in accordance with clinical guidelines before collection of cells for manufacturing.
Prolonged Cytopenias: In the clinical study, 41% of patients (52/127) experienced prolonged Grade 3 or 4 neutropenia and 49% (62/127) experienced prolonged Grade 3 or 4 thrombocytopenia that had not resolved by Month 1 following ABECMA infusion. In 83% (43/52) of patients who recovered from Grade 3 or 4 neutropenia after Month 1, the median time to recovery from ABECMA infusion was 1.9 months. In 65% (40/62) of patients who recovered from Grade 3 or 4 thrombocytopenia, the median time to recovery was 2.1 months.
Three patients underwent stem cell therapy for hematopoietic reconstitution due to prolonged cytopenia. Two of the three patients died from complications of prolonged cytopenia. Monitor blood counts prior to and after ABECMA infusion. Manage cytopenia with myeloid growth factor and blood product transfusion support.
Hypogammaglobulinemia: Hypogammaglobulinemia was reported as an adverse event in 21% (27/127) of patients; laboratory IgG levels fell below 500 mg/dl after infusion in 25% (32/127) of patients treated with ABECMA.
Monitor immunoglobulin levels after treatment with ABECMA and administer IVIG for IgG 2% of patients who received INREBIC included anemia (6%), diarrhea (3%), vomiting (3%), and thrombocytopenia (2%).
DRUG INTERACTIONS
Coadministration of INREBIC with a strong CYP3A4 inhibitor increases fedratinib exposure. Increased exposure may increase the risk of adverse reactions. Consider alternative therapies that do not strongly inhibit CYP3A4 activity. Alternatively, reduce the dose of INREBIC when administering with a strong CYP3A4 inhibitor. Avoid INREBIC with strong and moderate CYP3A4 inducers. Avoid INREBIC with dual CYP3A4 and CYP2C19 inhibitor. Coadministration of INREBIC with drugs that are CYP3A4 substrates, CYP2C19 substrates, or CYP2D6 substrates increases the concentrations of these drugs, which may increase the risk of adverse reactions of these drugs. Monitor for adverse reactions and adjust the dose of drugs that are CYP3A4, CYP2C19, or CYP2D6 substrates as necessary when coadministered with INREBIC.
PREGNANCY/LACTATION
Consider the benefits and risks of INREBIC for the mother and possible risks to the fetus when prescribing INREBIC to a pregnant woman. Due to the potential for serious adverse reactions in a breastfed child, advise patients not to breastfeed during treatment with INREBIC, and for at least 1 month after the last dose.
RENAL IMPAIRMENT
Reduce INREBIC dose when administered to patients with severe renal impairment. No modification of the starting dose is recommended for patients with mild to moderate renal impairment. Due to potential increase of exposure, patients with preexisting moderate renal impairment require more intensive safety monitoring, and if necessary, dose modifications based on adverse reactions.
HEPATIC IMPAIRMENT
Avoid use of INREBIC in patients with severe hepatic impairment.
Please see full Prescribing Information, including Boxed WARNING, and Summary of Product Characteristics for INREBIC.
About Bristol Myers Squibb and 2seventy bio
Abecma is being jointly developed and commercialized in the U.S. as part of a Co-Development, Co-Promotion, and Profit Share Agreement between Bristol Myers Squibb and 2seventy bio. Bristol Myers Squibb assumes sole responsibility for Abecma drug product manufacturing and commercialization outside of the U.S. The companies’ broad clinical development program for Abecma includes ongoing and planned clinical studies (KarMMa-2, KarMMa-3, KarMMa-9) in earlier lines of treatment for patients with multiple myeloma. For more information visit clinicaltrials.gov.
Bristol Myers Squibb: Creating a Better Future for People with Cancer
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 understanding of causal human biology, cutting-edge capabilities and differentiated research platforms uniquely position the company to approach 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. As a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that future study results may not be consistent with the results to date, that the product candidates described in this release may not receive regulatory approval for the indications described in this release, that any marketing approvals, if granted, may have significant limitations on their use, and, if approved, whether such product candidates for such indications will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2022, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.
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