Bristol Myers Squibb’s Presentations at ASH 2024 Reinforce Strength of Hematology Portfolio and Scientific Advances in Differentiated Research Platforms
Bristol Myers Squibb (NYSE: BMY) announced the presentation of over 90 data disclosures at the 66th ASH Annual Meeting, including 18 oral presentations from its hematology and cell therapy research programs. Key highlights include five-year follow-up data for Breyanzi in large B-cell lymphoma, new analyses from the COMMANDS trial for Reblozyl in myelodysplastic syndromes, and updates on cell therapy platforms including GPRC5D-directed CAR T cell therapy in multiple myeloma. The presentations showcase BMS's diverse portfolio across multiple blood diseases and innovative treatment approaches in targeted protein degradation and cell therapy.
Bristol Myers Squibb (NYSE: BMY) ha annunciato la presentazione di oltre 90 divulgazioni di dati nel 66° Congresso Annuale dell'ASH, inclusi 18 presentazioni orali dai suoi programmi di ricerca in ematologia e terapia cellulare. I punti salienti includono dati di follow-up a cinque anni per Breyanzi nel linfoma a grandi cellule B, nuove analisi dal trial COMMANDS per Reblozyl nelle sindromi mielodisplastiche e aggiornamenti sulle piattaforme di terapia cellulare, compresa la terapia CAR T diretta contro GPRC5D nel mieloma multiplo. Le presentazioni mettono in mostra il portafoglio diversificato di BMS attraverso molteplici malattie ematiche e approcci terapeutici innovativi nella degradazione mirata delle proteine e nella terapia cellulare.
Bristol Myers Squibb (NYSE: BMY) anunció la presentación de más de 90 divulgaciones de datos en el 66º Congreso Anual de ASH, incluyendo 18 presentaciones orales de sus programas de investigación en hematología y terapia celular. Los puntos destacados incluyen datos de seguimiento a cinco años para Breyanzi en linfoma de células B grandes, nuevos análisis del ensayo COMMANDS para Reblozyl en síndromes mielodisplásicos y actualizaciones sobre plataformas de terapia celular, incluida la terapia CAR T dirigida a GPRC5D en mieloma múltiple. Las presentaciones muestran el diverso portafolio de BMS a través de múltiples enfermedades hematológicas y enfoques innovadores en la degradación proteica específica y la terapia celular.
Bristol Myers Squibb (NYSE: BMY)는 제66회 ASH 연례 회의에서 90건 이상의 데이터 공개를 발표했으며, 이 중 18건의 구두 발표가 혈액학 및 세포 치료 연구 프로그램에서 이루어졌습니다. 주요 하이라이트로는 대형 B세포 림프종을 위한 Breyanzi의 5년 추적 데이터, 골수형성이상 증후군에서 Reblozyl을 위한 COMMANDS 시험의 새로운 분석, 다발성 골수종의 GPRC5D 지향 CAR T 세포 치료를 포함한 세포 치료 플랫폼에 대한 업데이트가 포함됩니다. 이 발표는 특정 혈액 질환에 대한 BMS의 다양한 포트폴리오와 표적 단백질 분해 및 세포 치료에 대한 혁신적인 치료 접근 방식을 보여줍니다.
Bristol Myers Squibb (NYSE: BMY) a annoncé la présentation de plus de 90 divulgations de données lors de la 66e réunion annuelle de l'ASH, y compris 18 présentations orales provenant de ses programmes de recherche en hématologie et en thérapie cellulaire. Les points forts incluent des données de suivi sur cinq ans pour Breyanzi dans le lymphome à grandes cellules B, de nouvelles analyses de l'essai COMMANDS pour Reblozyl dans les syndromes myélodysplasiques et des mises à jour sur les plateformes de thérapie cellulaire, y compris la thérapie CAR T dirigée contre GPRC5D dans le myélome multiple. Les présentations mettent en valeur le portefeuille diversifié de BMS à travers plusieurs maladies sanguines et des approches thérapeutiques innovantes dans la dégradation ciblée des protéines et la thérapie cellulaire.
Bristol Myers Squibb (NYSE: BMY) gab bekannt, dass auf dem 66. ASH-Jahrestreffen über 90 Datenausgaben präsentiert werden, darunter 18 mündliche Präsentationen aus seinen Forschungsprogrammen für Hämatologie und Zelltherapie. Zu den wichtigsten Punkten gehören Fünfjahresfolgedaten für Breyanzi beim großen B-Zell-Lymphom, neue Analysen aus der COMMANDS-Studie für Reblozyl bei myelodysplastischen Syndromen sowie Updates zu Zelltherapieplattformen, einschließlich der GPRC5D-gesteuerten CAR-T-Zelltherapie bei multiplem Myelom. Die Präsentationen zeigen das vielfältige Portfolio von BMS über verschiedene Blutkrankheiten und innovative Behandlungsansätze in der gezielten Proteindegradation und Zelltherapie.
- Over 90 data disclosures including 18 oral presentations demonstrating strong research pipeline
- Five-year follow-up survival data available for Breyanzi in large B-cell lymphoma
- Promising efficacy data for GPRC5D-directed CAR T cell therapy in multiple myeloma
- Expansion of research into new therapeutic areas including autoimmune diseases
- None.
Insights
This ASH conference presentation preview showcases significant developments in BMY's hematology portfolio, particularly in cell therapy and targeted protein degradation. Key highlights include:
1. Five-year survival data for Breyanzi in large B-cell lymphoma and new data showing superior outcomes compared to standard care
2. Promising results from GPRC5D-directed CAR T cell therapy in multiple myeloma, demonstrating potential in both BCMA-naïve and previously treated patients
3. New analyses from the COMMANDS trial supporting Reblozyl's efficacy in lower-risk myelodysplastic syndromes
4. Advancement in protein degradation platform with iberdomide showing strong activity in newly diagnosed multiple myeloma patients
The breadth and depth of data presentations (90+ disclosures, 18 oral presentations) demonstrate BMY's continued leadership in hematology and potential for multiple new revenue streams from their pipeline developments.
The data presentations reveal several potential market-moving developments:
1. Breyanzi's expanding footprint across multiple indications (LBCL, FL, CLL) with strong durability data strengthens its competitive position in the CAR-T market
2. The manufacturing reliability data for Abecma addresses a critical concern in the CAR-T space, potentially leading to improved market adoption
3. Novel CELMoD platform developments, particularly golcadomide and iberdomide, show promise in both blood cancers and autoimmune conditions
These advances could significantly impact BMY's market position in hematology and expand their addressable market, especially with the potential first-in-class treatments under development.
Data from more than 20 programs, including new research from cell therapy and targeted protein degradation platforms, showcase the depth and breadth of BMS’ diverse portfolio and ongoing leadership in blood diseases and beyond
“Our data at ASH reflect our unique ability to address unmet patient needs with our industry-leading cell therapy portfolio and the continued expansion of our work in targeted protein degradation. These advances have been built on decades of specialized research and experience across clinical development and dedication to patient-centric treatment approaches,” said Anne Kerber, senior vice president, head of late clinical development, Hematology, Oncology, and Cell Therapy (HOCT), Bristol Myers Squibb. “This meeting provides us with an opportunity to reinforce our commitment to this critical area of research and highlight our current efforts to transform how hematologic diseases are treated.”
Key data being presented by Bristol Myers Squibb and its partners at the 2024 ASH Annual Meeting and Exposition include:
Cell Therapy
- Multiple analyses underscoring durable efficacy and well-established safety of the best-in-class profile of Breyanzi® (lisocabtagene maraleucel; liso-cel) in large B-cell lymphoma (LBCL), including five-year follow-up overall survival (OS) data from the TRANSCEND NHL-001 trial, new data from the Phase 3 TRANSFORM 2L LBCL study showing deeper and more durable responses with Breyanzi over former standard of care using circulating tumor DNA (ctDNA) as an earlier surrogate of clinical outcome, and compelling real-world data from the Center for International Blood and Marrow Transplant Research (CIBMTR) Registry
- Longer-term results from TRANSCEND FL and TRANSCEND CLL 004 reinforcing Breyanzi’s best-in-class and best-in-disease profile in relapsed or refractory (R/R) follicular lymphoma (FL), and its durable responses, sustained complete remissions and updated safety profile in patients with R/R chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL)
- Additional evaluations highlighting efficacy and safety from the Phase 1/2 TRANSCEND CLL 004 trial analyzing Breyanzi in combination with ibrutinib in patients with R/R CLL and SLL
- New analysis highlighting global manufacturing capability, reliability and timely delivery for Abecma® (idecabtagene vicleucel; ide-cel) in relapsed or refractory multiple myeloma (RRMM)
- First OS and progression-free survival results from a Phase 1 study of GPRC5D-directed CAR T cell therapy (BMS-986393/CC-95266) across all dose levels, supporting first-in-class potential in both B-cell maturation antigen (BCMA)-naïve and BCMA-exposed patients with RRMM
- Cell therapy data highlighting its potential beyond blood cancers, with updated Phase 1 data for CD19 NEX-T CAR T in severe, refractory autoimmune diseases, for the first time including patients with multiple sclerosis
Anemia
- New COMMANDS trial analyses and real-world evidence on long-term benefit of Reblozyl® (luspatercept-aamt) for patients with lower-risk myelodysplastic syndromes (MDS) across subgroups, including patients with ring sideroblasts (RS) and low baseline serum erythropoietin (sEPO)
Targeted Protein Degradation
- Updated results from Phase 1/2 CC-220-MM-001 trial supporting clinical and pharmacological activity of iberdomide combined with daratumumab and dexamethasone in transplant-ineligible, newly-diagnosed MM patients, including those with high-risk markers
- Results from Phase 1/2 CA057-003 trial evaluating an all-oral combination of mezigdomide and novel agents (EZH2, BET and MEK inhibitors), showing promising efficacy and no new safety signals in patients with RRMM
- Multiple data sets highlighting the promising clinical profile of golcadomide across LBCL and FL, including new analyses from Phase 1b DLBCL-001 study showing golcadomide plus R-CHOP has high minimal residual disease (MRD) negativity in high-risk 1L LBCL, and longer follow-up from the Phase 1/2 NHL-001 study demonstrating the potential of golcadomide in combination with rituximab for R/R FL and R/R LBCL
- Preclinical analysis evaluating development of fetal hemoglobin (HbF)-activating CELMoD™ agent BMS-986470 for the treatment of sickle cell disease
- Multiple preclinical analyses evaluating potential first-in-class CELMoD agent BMS-986397 targeting casein kinase 1α (CK1α) in acute myeloid leukemia and high-risk MDS harboring functional TP53
- Preclinical results for potential first-in-class ligand-directed degrader of BCL6 BMS-986458 demonstrating anti-tumor efficacy in B-cell non-Hodgkin lymphoma (NHL)
Additional information about BMS’ presence at the meeting can be found on the ASH website.
Selected BMS studies at the 2024 ASH Annual Meeting and Exposition include:
Abstract Title |
Author |
Presentation Type/# |
Session Title |
Session Date/Time (PST) |
Autoimmune Disease |
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Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of BMS-986353 (CC-97540), a CD19-Directed Chimeric Antigen Receptor (CAR) T Cell Therapy Manufactured Using a Next-Generation Process, for Severe, Refractory Autoimmune Diseases: Updated Data from Ongoing Phase 1, Multicenter, Open-Label Studies |
Fabian Müller |
Session: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster I |
Saturday, December 7, 2024: 5:30 PM-7:30 PM (8:30 PM-10:30 PM ET) |
|
Acute Myeloid Leukemia (AML) |
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Synergistic Activity of BMS-986397, a First-in-Class α Cereblon (CRBN) E3 Ligase Modulator (CELMoD) Targeting Casein Kinase 1α (CK1α), in Combination with Venetoclax and/or Azacitidine in Preclinical Models of Acute Myeloid Leukemia (AML) |
Carmen Jimenez
|
|
Session: 604. Molecular Pharmacology and Drug Resistance: Myeloid Neoplasms: Poster I |
Saturday, December 7, 2024: 5:30 PM-7:30 PM (8:30 PM-10:30 PM ET) |
Beta Thalassemia |
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Improvement of Iron Overload Parameters in Patients with Transfusion-Dependent β-Thalassemia Treated with Luspatercept: Data from the Phase 3b Long-Term Rollover Study Following the BELIEVE Trial |
John Porter |
Session: 112. Thalassemia and Globin Gene Regulation: Poster II |
Sunday, December 8, 2024: 6:00 PM-8:00 PM (9:00 PM-11:00 PM ET) |
|
Luspatercept Improves Fatigue-Related Quality of Life through 5 Years of Treatment in Non-Transfusion Dependent Beta-Thalassemia |
Khaled Musallam |
Session: 112. Thalassemia and Globin Gene Regulation: Poster III |
Monday, December 9, 2024: 6:00 PM-8:00 PM (9:00 PM-11:00 PM ET) |
|
Lymphoma |
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Circulating Tumor DNA (ctDNA) As an Early Outcome Predictor in Patients (pts) with Second-Line (2L) Large B-Cell Lymphoma (LBCL) after Lisocabtagene Maraleucel (liso-cel) Versus Standard of Care (SOC) Treatment (tx) from the Phase 3, Randomized TRANSFORM Study |
Ash Alizadeh |
Session: 628. Aggressive Lymphomas: Cellular Therapies: Novel Strategies for Cell Therapies in Aggressive Lymphomas
|
Saturday, December 7, 2024: 10:45 AM (1:45 PM ET) |
|
Real-World (RW) Outcomes of Lisocabtagene Maraleucel (liso-cel) As Second-Line (2L) Therapy in Patients (pts) with Relapsed or Refractory (R/R) Large B-Cell Lymphoma (LBCL): First Results from the Center for International Blood and Marrow Transplant Research (CIBMTR) Registry |
Maria Silvina Odstrcil Bobillo
|
Session: 626. Aggressive Lymphomas: Clinical and Epidemiological: CARs, Bispecifics, and ADCs: Progress and Challenges in Aggressive B Cell Lymphoma |
Sunday, December 8, 2024: 9:45 AM (12:45 PM ET) |
|
Real-World (RW) Outcomes of Lisocabtagene Maraleucel (liso-cel) in Patients (pts) with Relapsed or Refractory (R/R) Large B-Cell Lymphoma (LBCL) and Secondary Central Nervous System (sCNS) Involvement from the Center for International Blood and Marrow Transplant Research (CIBMTR) Registry |
Sairah Ahmed |
Session: 626. Aggressive Lymphomas: Clinical and Epidemiological: CARs, Bispecifics, and ADCs: Progress and Challenges in Aggressive B Cell Lymphoma |
Sunday, December 8, 2024: 10:15 AM (1:15 PM ET) |
|
Golcadomide (GOLCA) Plus R-CHOP Has High Minimal Residual Disease (MRD) Negativity across High-Risk, Untreated Aggressive B-Cell Lymphoma (a-BCL) |
Arnaud Amzallag |
Session: 627. Aggressive Lymphomas: Pharmacologic Therapies: New R-CHOP Combinations for Treatment Naïve DLBCL |
Sunday, December 8, 2024: 12:30 PM (3:30 PM ET) |
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Golcadomide (GOLCA) ± Rituximab (RTX) Demonstrates Durable Efficacy and Is Well Tolerated in Patients (pts) with Relapsed/Refractory Follicular Lymphoma (R/R FL): Updated Results from the Phase 1/2 CC-99282-NHL-001 Study |
Julio C. Chavez |
Session: 623. Mantle Cell, Follicular, Waldenströms, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster II |
Sunday, December 8, 2024: 6:00 PM-8:00 PM (9:00 PM-11:00 PM ET) |
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Five-Year Survival of Patients (pts) from Transcend NHL 001 (TRANSCEND) Supports Curative Potential of Lisocabtagene Maraleucel (liso-cel) in Relapsed or Refractory (R/R) Large B-Cell Lymphoma (LBCL) |
Jeremy Abramson |
Session: 628. Aggressive Lymphomas: Cellular Therapies: Poster II
|
Sunday, December 8, 2024: 6:00 PM-8:00 PM (9:00 PM-11:00 PM ET) |
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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 (pts) with Refractory/Early Relapsed (R/R) Large B-Cell Lymphoma (LBCL): Update with 34 Months of Liso-Cel Follow-up |
Jeremy Abramson |
Session: 628. Aggressive Lymphomas: Cellular Therapies: Poster II |
Sunday, December 8, 2024: 6:00 PM-8:00 PM (9:00 PM-11:00 PM ET) |
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Degradation of Ikaros Induces Neutropenia through Altered Transcriptional Programming across Multiple Stages of Neutrophil Development and Maturation |
Ajit Dhadve |
Session: 201. Granulocytes, Monocytes, and Macrophages: Poster II |
Sunday, December 8, 2024: 6:00 PM-8:00 PM (9:00 PM-11:00 PM ET) |
|
Matching-Adjusted Indirect Comparison (MAIC) of Efficacy and Safety Outcomes for Lisocabtagene Maraleucel (liso-cel) Versus Axicabtagene Ciloleucel (axi-cel) and Tisagenlecleucel (tisa-cel) for the Treatment of Third-Line or Later (3L+) Relapsed or Refractory (R/R) Follicular Lymphoma (FL) |
Alexander P. Boardman |
Session: 623. Mantle Cell, Follicular, Waldenström, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster II |
Sunday, December 8, 2024: 6:00 PM-8:00 PM (9:00 PM-11:00 PM ET) |
|
Longer Follow-up of Golcadomide (GOLCA), a Cereblon E3 Ligase Modulator (CELMoD™) Agent ± Rituximab (RTX), in Patients with Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) |
Jean-Marie Michot |
Session: 627. Aggressive Lymphomas: Pharmacologic Therapies: Novel Monotherapies or Novel Disease Indications
|
Monday, December 9, 2024: 3:45 PM (6:45 PM ET) |
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Lisocabtagene Maraleucel (liso-cel) Combined with Ibrutinib (ibr) for Patients (pts) with Relapsed or Refractory (R/R) Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL): Primary Results from the Open-Label, Phase 1/2 Transcend CLL 004 Study |
William Wierda |
Session: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Treating Refractory Disease-Novel Agents and Quality-of-Life |
Monday, December 9, 2024: 3:45 PM (6:45 PM ET) |
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Deciphering the Mechanism of Action of the Novel CELMoD™, Golcadomide, during Germinal Center B Cell Immune Response and in a Preclinical Mouse Model of Follicular Lymphoma |
Caroline Huber |
Session: 605. Molecular Pharmacology and Drug Resistance: Lymphoid Neoplasms: Novel Therapeutic Approaches in Lymphoma
|
Monday, December 9, 2024: 4:30 PM (7:30 PM ET) |
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BMS-986458 a Potential First-in-Class, Highly Selective, Potent and Well Tolerated BCL6 Ligand Directed Degrader (LDD) Demonstrates Multi-Modal Anti-Tumor Efficacy for the Treatment of B-Cell Non-Hodgkin's Lymphoma |
Lynda Groocock |
Session: 605. Molecular Pharmacology and Drug Resistance: Lymphoid Neoplasms: Novel Therapeutic Approaches in Lymphoma |
Monday, December 9, 2024: 5:00 PM (8:00 PM ET) |
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Lisocabtagene Maraleucel (liso-cel) in Patients (pts) with Relapsed or Refractory (R/R) Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL): Updated Follow-up of Transcend CLL 004 |
Tanya Siddiqi |
Session: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster III |
Monday, December 9, 2024: 6:00 PM-8:00 PM (9:00 PM-11:00 PM ET) |
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Lisocabtagene Maraleucel (liso-cel) in Patients (pts) with Relapsed or Refractory (R/R) Follicular Lymphoma (FL): Transcend FL 2-Year Follow-up |
Loretta J. Nastoupil |
Session: 623. Mantle Cell, Follicular, Waldenström, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster III |
Monday, December 9, 2024: 6:00 PM-8:00 PM (9:00 PM-11:00 PM ET) |
|
Multiple Myeloma |
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Iberdomide, Daratumumab, and Dexamethasone Shows Deep Antimyeloma Activity across Molecular Patient Subsets with Transplant-Ineligible Newly Diagnosed Multiple Myeloma from the CC-220-MM-001 Trial |
Michael Amatangelo |
Session: 654. Multiple Myeloma: Pharmacologic Therapies: Poster I
|
Saturday, December 7, 2024: 5:30 PM-7:30 PM (8:30 PM-10:30 PM ET) |
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BMS-986393, a G Protein–Coupled Receptor Class C Group 5 Member D (GPRC5D)-Targeted CAR T Cell Therapy, in Patients (pts) with Relapsed/Refractory (RR) Multiple Myeloma (MM) and 1–3 Prior Regimens: Updated Phase 1 Safety and Efficacy Results |
Susan Bal |
Session: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster I |
Saturday, December 7, 2024: 5:30 PM-7:30 PM (8:30 PM-10:30 PM ET) |
|
Mezigdomide (MEZI) in Novel-Novel Combinations for Relapsed or Refractory Multiple Myeloma (RRMM): Preliminary Results from the CA057-003 Trial |
Luciano Costa |
Session: 654. Multiple Myeloma: Pharmacologic Therapies: Optimizing Therapy in Newly Diagnosed Myeloma and Beyond |
Sunday, December 8, 2024: 5:30 PM (8:30 PM ET) |
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Biomarker Analyses of the CC-92480-MM-001 Trial to Guide Combinatorial Strategies for Mezigdomide |
Tracy Chow |
Session: 651. Multiple Myeloma and Plasma Cell Dyscrasias: Basic and Translational: Poster II |
Sunday, December 8, 2024: 6:00 PM-8:00 PM (9:00 PM-11:00 PM ET) |
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Idecabtagene Vicleucel (Ide-cel) in Patients (Pts) with Newly Diagnosed Multiple Myeloma (NDMM) with an Inadequate Response to Front-Line Autologous Stem Cell Transplantation (ASCT): KarMMa-2 Cohort 2c Extended Follow-up |
Barry Paul |
Session: 655. Multiple Myeloma: Cellular Therapies: Poster II |
Sunday, December 8, 2024: 6:00 PM-8:00 PM (9:00 PM-11:00 PM ET) |
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Global Manufacturing Experience with Idecabtagene Vicleucel in Patients with Relapsed and Refractory Multiple Myeloma |
Surbhi Sidana |
Session: 711. Cell Collection and Manufacturing of HSPCs, CAR-T Cells, and Other Cellular Therapy Products: Poster II |
Sunday, December 8, 2024: 6:00 PM-8:00 PM (9:00 PM-11:00 PM ET) |
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| Cross-Cohort Correlative Analysis of Clinically High-Risk Patients (pts) Treated with Idecabtagene Vicleucel (ide-cel) in KarMMa-2: Association between Progression-Free Survival (PFS) and Tumor Burden and Immune Status at Apheresis | Maria Chaudhry |
Session: 655. Multiple Myeloma: Cellular Therapies: Poster II |
Sunday, December 8, 2024: 6:00 PM-8:00 PM (9:00 PM-11:00 PM ET) |
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Efficacy and Safety with Extended Follow-up in a Phase 1 Study of BMS-986393, a G Protein–Coupled Receptor Class C Group 5 Member D (GPRC5D)–Targeted CAR T Cell Therapy, in Patients (pts) with Heavily Pretreated Relapsed/Refractory (R/R) Multiple Myeloma |
Susan Bal |
Session: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Emerging Targeting Approaches of Cell Therapies for Hematologic Malignancies |
Monday, December 9, 2024: 3:30 PM (6:30 PM ET) |
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Mezigdomide (MEZI) Plus Dexamethasone (DEX) and Bortezomib (BORT) or Carfilzomib (CFZ) in Patients (pts) with Relapsed/Refractory Multiple Myeloma (RRMM): Updated Results From the CC-92480-MM-002 Trial |
Irwindeep Sandhu |
Session: 654. Multiple Myeloma: Pharmacologic Therapies: Into the Future: New Drugs and Combinations in Multiple Myeloma |
Monday, December 9, 2024: 5:30 PM (8:30 PM ET) |
|
Myelodysplastic Syndromes |
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The Burden of Transfusion Dependence on Caregivers of Patients with Lower-Risk Myelodysplastic Syndromes in |
Maria Diez-Campelo |
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Session: 908. Outcomes Research: Myeloid Malignancies: Identifying Problems and Providing Solutions to Delivering Myeloid Malignancy Care |
Saturday, December 7, 2024: 10:15 AM (1:15 PM ET) |
Long-Term Response Analysis of Transfusion Independence in Erythropoiesis Stimulating Agent-Naive Patients with Very Low-, Low-, or Intermediate-Risk Myelodysplastic Syndromes Treated with Luspatercept Vs Epoetin Alfa in the COMMANDS Trial |
Guillermo Garcia-Manero |
Session: 637. Myelodysplastic Syndromes: Clinical and Epidemiological: Defining and Treating Low Risk MDS |
Saturday, December 7, 2024: 4:15 PM (7:15 PM ET) |
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Clinical Benefits of Achieving Hemoglobin (Hb) Levels ≥ 10 g/dL in Transfusion-Dependent (TD) Erythropoiesis-Stimulating Agent (ESA)-Naive Patients (Pts) with Lower-Risk (LR) Myelodysplastic Syndromes (MDS) Treated with Luspatercept in the COMMANDS Trial |
Valeria Santini |
Session: 637. Myelodysplastic Syndromes: Clinical and Epidemiological: Poster I |
Saturday, December 7, 2024: 5:30 PM-7:30 PM (8:30 PM-10:30 PM ET)
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Changes in Red Blood Cell Transfusion Burden with Luspatercept Versus Epoetin Alfa in Patients with Lower-Risk Myelodysplastic Syndromes in the Phase 3, Open-Label, Randomized, Controlled COMMANDS Trial |
Guillermo Garcia-Manero |
Session: 637. Myelodysplastic Syndromes: Clinical and Epidemiological: Poster I |
Saturday, December 7, 2024: 5:30 PM-7:30 PM (8:30 PM-10:30 PM ET) |
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Real-World Treatment Patterns and Outcomes with Oral Azacitidine Maintenance Therapy in Patients with Acute Myeloid Leukemia |
Pramila Krishnamurthy |
Session: 908. Outcomes Research: Myeloid Malignancies: Poster I |
Saturday, December 7, 2024: 5:30 PM-7:30 PM (8:30 PM-10:30 PM ET)
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Health-Related Quality of Life of Luspatercept Versus Epoetin Alfa in Red Blood Cell Transfusion-Dependent Lower-Risk Myelodysplastic Syndromes: Results from the Final Datacut of the Phase 3 COMMANDS Study |
Esther N. Oliva |
Session: 637. Myelodysplastic Syndromes: Clinical and Epidemiological: Poster II |
Sunday, December 8, 2024: 6:00 PM-8:00 PM (9:00 PM-11:00 PM ET) |
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Impact of Luspatercept on Healthcare Resource Use (HCRU) Among Patients with Lower-Risk, Myelodysplastic Syndromes (LR-MDS): A Medical Record Review in |
Maria Diez-Campelo |
Session: 903. Health Services and Quality Improvement: Myeloid Malignancies: Poster III |
Monday, December 9, 2024: 6:00 PM-8:00 PM (9:00 PM-11:00 PM ET) |
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BMS-986397, a First-in-Class Molecular Glue Degrader of Casein Kinase 1α (CK1α) for the Treatment of Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndrome (HR-MDS) Harboring Functional TP53 |
Carmen Jiminez |
Session: 604. Molecular Pharmacology and Drug Resistance: Myeloid Neoplasms: Poster III |
Monday, December 9, 2024: 6:00 PM-8:00 PM (9:00 PM-11:00 PM ET) |
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Myelofibrosis |
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Efficacy and Safety of Fedratinib in Patients with Myelofibrosis and Low Baseline Platelet Counts in the Phase 3 Randomized FREEDOM2 Trial |
Haifa Kathrin Al-Ali |
Session: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: JAK Inhibitors in MPDs, Novel Insights and Next-Gen Agents |
Sunday, December 8, 2024: 9:45 AM (12:45 PM ET) |
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Burden and Clinical Outcomes in Patients (pts) with Myelofibrosis (MF) and Anemia Treated with Ruxolitinib (RUX): Data from the Veterans Affairs Corporate Data Warehouse (VACDW) |
John O. Mascarenhas |
Session: 908. Outcomes Research: Myeloid Malignancies: Poster II |
Sunday, December 8, 2024: 6:00 PM-8:00 PM (9:00 PM-11:00 PM ET) |
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Sickle Cell Disease |
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Development of a ZBTB7A and Wiz Dual Degrading, HbF-Activating CELMoD™ for the Treatment of Sickle Cell Disease |
Emily Rychak |
Session: 113. Sickle Cell Disease, Sickle Cell Trait, and Other Hemoglobinopathies, Excluding Thalassemias: Basic and Translational: Identification of New Molecular Targets to Modulate Sickle Cell Disease |
Saturday, December 7, 2024: 2:00 PM (5:00 PM ET) |
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Rap-536, a Murine Luspatercept Analog Ameliorates Anemia and Vaso-Occlusion in Experimental Model of Sickle Cell Disease |
Thiago T. Maciel |
Session: 113. Sickle Cell Disease, Sickle Cell Trait, and Other Hemoglobinopathies, Excluding Thalassemias: Basic and Translational: Attenuating Sickle Cell Disease Complications: Lessons from Pre-clinical Models |
Sunday, December 8, 2024: 5:00 PM (8:00 PM ET) |
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Thrombosis and Anticoagulation |
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Reversal of The Anticoagulant Effect of Milvexian by 4-Factor PCC and rFVIIa in Healthy Participants* |
Victor Dishy |
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Session: 332. Thrombosis and Anticoagulation: Clinical and Epidemiological: Poster II |
Sunday, December 8, 2024: 6:00 PM-8:00 PM (9:00 PM-11:00 PM ET) |
*Sponsored by the Bristol Myers Squibb-Johnson & Johnson Collaboration
Reblozyl is being developed and commercialized through a global collaboration with Merck following Merck’s acquisition of Acceleron Pharma, Inc. in November 2021.
Abecma is being jointly developed and commercialized in the
About Milvexian*
Milvexian is an investigational oral, highly selective Factor XIa (FXIa) inhibitor, part of a new class of anticoagulants in development aimed at preventing harmful clotting that restricts blood flow (thrombosis) while preserving the normal clotting process (hemostasis). As a result, milvexian could potentially reduce major cardiovascular events due to harmful clotting without significantly increasing the risk of bleeding. It is currently being studied in the Phase 3 Librexia program, the most comprehensive FXIa clinical development program to date, for the prevention and treatment of major thrombotic conditions.
*Milvexian is an investigational agent and has not been approved for use in any country, for any indication.
BREYANZI
BREYANZI 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:
- refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or
- refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age; or
- relapsed or refractory disease after two or more lines of systemic therapy.
Limitations of Use: BREYANZI is not indicated for the treatment of patients with primary central nervous system lymphoma.
- adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least 2 prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
- adult patients with relapsed or refractory follicular lymphoma (FL) who have received 2 or more prior lines of systemic therapy. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
- adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least 2 prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor.
Important Safety Information
WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, AND SECONDARY HEMATOLOGICAL MALIGNANCIES
- 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.
- T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including BREYANZI.
- 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. In clinical trials of BREYANZI, which enrolled a total of 702 patients with non-Hodgkin lymphoma (NHL), CRS occurred in
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.
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 clinical trials of BREYANZI, CAR T cell-associated neurologic toxicities occurred in
The most common neurologic toxicities (≥
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.
Further information is available at www.BreyanziREMS.com, or contact Bristol Myers Squibb at 1-866-340-7332.
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 clinical trials of BREYANZI, infections of any grade occurred in
Febrile neutropenia developed after BREYANZI infusion in
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 clinical trials of BREYANZI, 35 of 38 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. In clinical trials of BREYANZI, Grade 3 or higher cytopenias persisted at Day 29 following BREYANZI infusion in
Hypogammaglobulinemia
B-cell aplasia and hypogammaglobulinemia can occur in patients receiving BREYANZI. In clinical trials of BREYANZI, hypogammaglobulinemia was reported as an adverse reaction in
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. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including BREYANZI. Mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes. 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.
Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome (IEC-HS)
Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome (IEC-HS), including fatal or life-threatening reactions, occurred following treatment with BREYANZI. Three of 89 (
Adverse Reactions
The most common adverse reaction(s) (incidence ≥
- LBCL are fever, cytokine release syndrome, fatigue, musculoskeletal pain, and nausea. The most common Grade 3-4 laboratory abnormalities include lymphocyte count decrease, neutrophil count decrease, platelet count decrease, and hemoglobin decrease.
- CLL/SLL are cytokine release syndrome, encephalopathy, fatigue, musculoskeletal pain, nausea, edema, and diarrhea. The most common Grade 3-4 laboratory abnormalities include neutrophil count decrease, white blood cell decrease, hemoglobin decrease, platelet count decrease, and lymphocyte count decrease.
- FL is cytokine release syndrome. The most common Grade 3-4 laboratory abnormalities include lymphocyte count decrease, neutrophil count decrease, and white blood cell decrease.
- MCL are cytokine release syndrome, fatigue, musculoskeletal pain, and encephalopathy. The most common Grade 3-4 laboratory abnormalities include neutrophil count decrease, white blood cell decrease, and platelet count decrease.
Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide.
Abecma
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 two or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
IMPORTANT SAFETY INFORMATION
WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, PROLONGED CYTOPENIA and SECONDARY HEMATOLOGICAL MALIGNANCIES
- Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with ABECMA. Do not administer ABECMA to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
- Neurologic Toxicities, which may be severe or life-threatening, occurred following treatment with ABECMA, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with ABECMA. Provide supportive care and/or corticosteroids as needed.
- Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS) including fatal and life-threatening reactions, occurred in patients following treatment with ABECMA. HLH/MAS can occur with CRS or neurologic toxicities.
- Prolonged Cytopenia with bleeding and infection, including fatal outcomes following stem cell transplantation for hematopoietic recovery, occurred following treatment with ABECMA.
- T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including ABECMA.
- ABECMA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ABECMA REMS.
Warnings and Precautions:
Early Death:
In KarMMa-3, a randomized (2:1), controlled trial, a higher proportion of patients experienced death within 9 months after randomization in the ABECMA arm (45/254;
Cytokine Release Syndrome (CRS):
CRS, including fatal or life-threatening reactions, occurred following treatment with ABECMA. Among patients receiving ABECMA for relapsed refractory multiple myeloma in the KarMMa and KarMMa-3 studies (N=349), CRS occurred in
The most common manifestations of CRS (greater than or equal to
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. HLH/MAS is a potentially life-threatening condition. In patients with progressive symptoms of CRS or refractory CRS despite treatment, evaluate for evidence of HLH/MAS.
Of the 349 patients who received ABECMA in clinical trials, 226 (
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. Ensure that a minimum of 2 doses of tocilizumab are available prior to infusion of ABECMA. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time.
Neurologic Toxicities:
Neurologic toxicities, including immune-effector cell-associated neurotoxicity (ICANS), which may be severe or life-threatening, occurred concurrently with CRS, after CRS resolution, or in the absence of CRS following treatment with ABECMA.
In patients receiving ABECMA in the KarMMa and KarMMa-3 studies, CAR T cell-associated neurotoxicity occurred in
At the safety update for KarMMa-3 study, one patient developed fatal neurotoxicity 43 days after ABECMA. In KarMMa, 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.
Cerebral edema has been associated with ABECMA in a patient in another study in multiple myeloma. Grade 3 myelitis and Grade 3 parkinsonism have occurred after treatment 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):
In patients receiving ABECMA in the KarMMa and KarMMa-3 studies, HLH/MAS occurred in
In KarMMa-3, one patient had Grade 5, two patients had Grade 4 and two patients had Grade 3 HLH/MAS. The patient with Grade 5 HLH/MAS also had Grade 5 candida sepsis and Grade 5 CRS. In another patient who died due to stroke, the Grade 4 HLH/MAS had resolved prior to death. Two cases of Grade 3 and one case of Grade 4 HLH/MAS had resolved.
In KarMMa, one patient treated in the 300 x 106 CAR-positive T cells dose cohort developed fatal multi-organ HLH/MAS with CRS. In another patient with fatal bronchopulmonary aspergillosis, HLH/MAS was contributory to the fatal outcome. Three cases of Grade 2 HLH/MAS resolved.
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 contact Bristol Myers Squibb at 1-866-340-7332.
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.
In all patients receiving ABECMA in the KarMMa and KarMMa-3 studies, infections (all grades) occurred in
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
Viral Reactivation: Cytomegalovirus (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. Consider antiviral therapy to prevent viral reactivation per local institutional guidelines/clinical practice.
Prolonged Cytopenias:
In patients receiving ABECMA in the KarMMa and KarMMa-3 studies,
Monitor blood counts prior to and after ABECMA infusion. Manage cytopenia with myeloid growth factor and blood product transfusion support according to local institutional guidelines.
Hypogammaglobulinemia:
In all patients receiving ABECMA in the KarMMa and KarMMa-3 studies, hypogammaglobulinemia was reported as an adverse event in
Hypogammaglobulinemia either as an adverse reaction or laboratory IgG level below 500 mg/dL after infusion occurred in
Monitor immunoglobulin levels after treatment with ABECMA and administer IVIG for IgG <400 mg/dl. Manage appropriately per local institutional guidelines, including infection precautions and antibiotic or antiviral prophylaxis.
Use of Live Vaccines: The safety of immunization with live viral vaccines during or after ABECMA 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 ABECMA treatment, and until immune recovery following treatment with ABECMA.
Secondary Malignancies:
Patients treated with ABECMA may develop secondary malignancies. In KarMMa-3, myeloid neoplasms (four cases of myelodysplastic syndrome and one case of acute myeloid leukemia) occurred in
T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including ABECMA. Mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes.
Monitor life-long 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 of secondary malignancy.
Effects on Ability to Drive and Operate Machinery:
Due to the potential for neurologic events, including altered mental status or seizures, patients receiving ABECMA are at risk for altered or decreased consciousness or coordination in the 8 weeks following ABECMA infusion. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period.
Adverse Reactions:
The most common nonlaboratory adverse reactions (incidence greater than or equal to
Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide.
Reblozyl
REBLOZYL is indicated in the
- anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.
- anemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell (RBC) transfusions.
- anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell (RBC) units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndrome with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T).
REBLOZYL is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia. In the
WARNINGS AND PRECAUTIONS
Thrombosis/Thromboembolism
In adult patients with beta thalassemia, thromboembolic events (TEE) were reported in 8/223 (
Hypertension
Hypertension was reported in
Extramedullary Hematopoietic (EMH) Masses
In adult patients with transfusion-dependent beta thalassemia, EMH masses were observed in
In a study of adult patients with non-transfusion-dependent beta thalassemia, a higher incidence of EMH masses was observed in
Possible risk factors for the development of EMH masses in patients with beta thalassemia include history of EMH masses, splenectomy, splenomegaly, hepatomegaly, or low baseline hemoglobin (<8.5 g/dL). Signs and symptoms may vary depending on the anatomical location. Monitor patients with beta thalassemia at initiation and during treatment for symptoms and signs or complications resulting from the EMH masses and treat according to clinical guidelines. Discontinue treatment with REBLOZYL in case of serious complications due to EMH masses. Avoid use of REBLOZYL in patients requiring treatment to control the growth of EMH masses.
Embryo-Fetal Toxicity
REBLOZYL may cause fetal harm when administered to a pregnant woman. REBLOZYL caused increased post-implantation loss, decreased litter size, and an increased incidence of skeletal variations in pregnant rat and rabbit studies. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 3 months after the final dose.
ADVERSE REACTIONS
Beta-Thalassemia
Serious adverse reactions occurred in
Most common adverse reactions (at least
ESA-naïve adult patients with Myelodysplastic Syndromes
Grade ≥3 (≥
The most common (≥
ESA-refractory or -intolerant adult patients with Myelodysplastic Syndromes
Grade ≥3 (≥
The most common (≥
LACTATION
It is not known whether REBLOZYL is excreted into human milk or absorbed systemically after ingestion by a nursing infant. REBLOZYL was detected in milk of lactating rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk. Because many drugs are excreted in human milk, and because of the unknown effects of REBLOZYL in infants, a decision should be made whether to discontinue nursing or to discontinue treatment. Because of the potential for serious adverse reactions in the breastfed child, breastfeeding is not recommended during treatment and for 3 months after the last dose.
DRUG ABUSE POTENTIAL
Abuse: Abuse of REBLOZYL may be seen in athletes for the effects on erythropoiesis. Misuse of drugs that increase erythropoiesis, such as REBLOZYL, by healthy persons may lead to polycythemia, which may be associated with life-threatening cardiovascular complications.
Please see accompanying
Bristol Myers Squibb: Unlocking the Full Potential of Cell Therapy
A pioneer in harnessing the immune system to fight cancer and an established leader in cell therapy, Bristol Myers Squibb is uniquely positioned to unlock the full potential of this technology across blood cancers and within new frontiers, including autoimmune disease.
Bristol Myers Squibb is currently the only company with two approved CAR T cell therapies with two distinct targets, available in major markets around the world. Our bold vision for the future is one in which hundreds of thousands of patients can be treated with cell therapy’s transformational potential.
The building blocks to realize this ambition—a promising and differentiated pipeline, extensive translational and clinical data sets, a deep bench of talent, and robust manufacturing capabilities—are in our cells. We are laser-focused on advancing the field of cell therapy toward a true revolution for patients. Learn more about the science behind cell therapy and ongoing progress at Bristol Myers Squibb here.
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 the Bristol Myers Squibb-Johnson & Johnson Collaboration
Bristol Myers Squibb and Johnson & Johnson, two unsurpassed leaders in cardiovascular care, are determined to close the gap in unmet needs in thrombosis management by overcoming the limits of today’s treatments. The collaboration to develop and commercialize milvexian aims to leverage the combined scientific expertise and world-class commercial capabilities of each company, to improve patient outcomes. The alliance is uniquely equipped to deliver on the promise of FXIa inhibitors and is working diligently to ensure cutting-edge safe and effective treatment options are available for patients.
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, X, 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, treatments and combination treatments described in this release for the indications described in this release may not receive regulatory approval for such indications, any marketing approvals, if granted, may have significant limitations on their use, and, if approved, whether such product candidates, treatments and combination treatments 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, 2023, 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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