First presentation of data from the Phase 3 TRANSFORM study of CD19-directed CAR T cell therapy Breyanzi (lisocabtagene maraleucel) in second-line relapsed or refractory (R/R) large B-cell lymphoma
Research from industry-leading multiple myeloma program with new analyses for the first-in-class anti-BCMA CAR T cell therapy, Abecma(idecabtagene vicleucel), as well as studies in heavily-treated disease highlighting CELMoD®s, with new safety and efficacy results for iberdomide and first presentation of combination data with CC-92480
First clinical results for anti-SIRPα antibody CC-95251 and CELMoD® CC-99282 in patients with R/R non-Hodgkin’s lymphoma showcasing pipeline potential through multiple modalities
Bristol Myers Squibb (NYSE:BMY) today announced the presentation of research across a wide range of hematologic diseases at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition, which will take place in Atlanta, Georgia, and virtually, from December 11 to 14, 2021. Data from more than 80 company-sponsored studies will be featured, including 23 oral presentations, highlighting key research and development programs in lymphomas, leukemias, multiple myeloma and myeloid diseases, and showcasing our commitment to delivering transformative medicines across major hematologic diseases.
Key data being presented by Bristol Myers Squibb and its partners at the 2021 ASH Annual Meeting and Exposition include:
- First presentation of results from pivotal Phase 3 TRANSFORM study evaluating CD19-directed chimeric antigen receptor (CAR) T cell therapy Breyanzi (lisocabtagene maraleucel) head-to-head against the current standard of care treatment approach for second-line relapsed or refractory (R/R) large B-cell lymphoma (LBCL)
- Two-year follow-up data from the pivotal TRANSCEND NHL 001 study of Breyanzi in third-line and later R/R LBCL
- First clinical results for anti-SIRPα antibody CC-95251 plus rituximab, as well as first clinical results for CELMoD® CC-99282, both in patients with R/R non-Hodgkin’s lymphoma
- First disclosure of safety and efficacy results from dose expansion of the MM-001 study evaluating CELMoD® iberdomide in combination with dexamethasone in patients with R/R multiple myeloma
- First disclosure of preliminary results from the Phase 1/2 MM-002 study of CELMoD® CC-92480 in combination with dexamethasone and bortezomib in patients with R/R multiple myeloma
- Further analyses from the pivotal KarMMa trial in R/R multiple myeloma evaluated baseline predictors of complete responses and outcomes for patients treated with subsequent anti-myeloma therapies, including alternative B-cell maturation antigen (BCMA)-directed therapies, after treatment with Abecma (idecabtagene vicleucel),the first-in-class BCMA-directed CAR T cell therapy
- Abstracts highlighting multiple Bristol Myers Squibb’s therapies in hard-to-treat myeloid diseases, including longer-term data and analyses of different acute myeloid leukemia subtypes and baseline characteristics with Onureg® (azacitidine tablets) from the Phase 3 QUAZAR® AML-001 study and safety with Inrebic® (fedratinib) from the Phase 3b FREEDOM trial in myelofibrosis
- Updated analyses of Reblozyl® (luspatercept-aamt) from the Phase 2 BEYOND study in beta thalassemia and from the Phase 3 MEDALIST study in lower-risk myelodysplastic syndromes
“Our presence at ASH continues our longstanding commitment to hematology and underscores the potential of our innovative research platforms to deliver meaningful, new treatment options for people with unmet needs living with hematologic diseases,” said Samit Hirawat, M.D., executive vice president, chief medical officer, global drug development, Bristol Myers Squibb. “These data reinforce our progress in advancing transformative research across a wide range of hematologic malignancies including multiple myeloma, lymphoma, and myeloid diseases.”
Selected Bristol Myers Squibb studies at the 63rd ASH Annual Meeting and Exposition include:
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Abstract Title |
Author |
Presentation Type/# |
Session Title |
Session Date/Time |
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Acute Myeloid Leukemia |
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Prognostic Impact of NPM1 and FLT3 Mutations at Diagnosis and Presence of Measurable Residual Disease (MRD) after Intensive Chemotherapy (IC) for Patients with Acute Myeloid Leukemia (AML) in Remission: Outcomes from the QUAZAR AML-001 Trial of Oral Azacitidine (Oral-AZA) Maintenance |
Hartmut Döhner |
Oral Abstract #804 |
617. Acute Myeloid Leukemia: Biomarkers, Molecular Markers and Minimal Residual Disease in Diagnosis and Prognosis: New options of risk assessment and prediction of therapy response in AML |
Monday, December 13, 5:45 PM |
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Long-term Overall Survival (OS) with Oral Azacitidine (Oral-AZA) in Patients with Acute Myeloid Leukemia (AML) in First Remission after Intensive Chemotherapy (IC): Updated Results from the Phase 3 QUAZAR AML-001 Trial |
Andrew Wei |
Oral Abstract #871 |
615. Acute Myeloid Leukemias: Commercially Available Therapies, Excluding Transplantation and Cellular Immunotherapies: Updates in treatment for high-risk AML |
Monday, December 13, 6:15 PM |
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Beta Thalassemia |
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Luspatercept Redistributes Body Iron to the Liver in Transfusion-Dependent-Thalassemia (TDT) During Erythropoietic Response |
Maciej Garbowski
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Oral Abstract #761
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102. Iron Homeostasis and Biology: Disorders of Iron and Heme and Novel Treatments |
Monday, December 13, 5:30 PM
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Luspatercept Improves Health-Related Quality of Life (HRQoL) Symptoms and RBC Transfusion Burden in Patients with Non-Transfusion-Dependent β-thalassemia (NTDT) in the BEYOND Trial |
Antonis Kattamis |
Poster Abstract #3081 |
112. Thalassemia and Globin Gene Regulation: Poster III |
Monday, December 13, 6:00 – 8:00 PM |
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Graft vs. Host Disease |
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Overall Survival of Patients Treated with Abatacept in Combination with a Calcineurin Inhibitor and Methotrexate After Allogeneic Hematopoietic Stem Cell Transplantation – Analysis of the Center for International Blood and Marrow Transplant Research Database |
Leslie Kean |
Poster Abstract #3912 |
722. Allogeneic Transplantation: Acute and Chronic GVHD, Immune Reconstitution: Poster III |
Monday, December 13, 6:00 – 8:00 PM |
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Lymphoma |
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Lisocabtagene Maraleucel (liso-cel), a CD19-Directed Chimeric Antigen Receptor (CAR) T Cell Therapy, Versus Standard of Care (SOC) with Salvage Chemotherapy (CT) Followed by Autologous Stem Cell Transplantation (ASCT) as Second-Line (2L) Treatment in Patients (Pts) with Relapsed or Refractory (R/R) Large B-Cell Lymphoma (LBCL): Results from the Randomized Phase 3 TRANSFORM Study |
Manali Kamdar
|
Oral Abstract #91
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704. Cellular Immunotherapies: Cellular Therapies for Lymphomas |
Saturday, December 11, 9:30 AM
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Ruxolitinib Plus Nivolumab in Patients with R/R Hodgkin Lymphoma after Failure of Check-Point Inhibitors: Preliminary Report on Safety and Efficacy |
Veronika Bachanova
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Oral Abstract #230
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624. Hodgkin Lymphomas and T/NK cell Lymphomas: Hodgkin Lymphoma Clinical Trials Hematology Disease Topics & Pathways: Clinical Trials |
Saturday, December 11, 2:15 PM |
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Nivolumab First-Line Therapy for Elderly Hodgkin Lymphoma Patients: a LYSA Phase II Study
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Julien Lazarovici
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Oral Abstract #232
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624. Hodgkin Lymphomas and T/NK cell Lymphomas: Hodgkin Lymphoma Clinical Trials |
Saturday, December 11, 2:45 PM
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OUTREACH: Results from a Phase 2 Study of Lisocabtagene Maraleucel (liso-cel) Administered as Inpatient (Inpt) or Outpatient (Outpt) Treatment in the Nonuniversity Setting in Patients (Pts) with R/R Large B-Cell Lymphoma (LBCL) |
John Godwin
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Poster Abstract #1762
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704. Cellular Immunotherapies: Clinical: Poster I |
Saturday, December 11, 5:30 – 7:30 PM
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Six-Year Results from the Phase 3 Randomized Study Relevance Show Similar Outcomes for Previously Untreated Follicular Lymphoma Patients Receiving Lenalidomide Plus Rituximab (R2) Versus Rituximab-Chemotherapy Followed By Rituximab Maintenance |
Franck Morschhauser
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Poster Abstract #2417
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623. Mantle Cell, Follicular, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster II |
Sunday, December 12, 6:00 – 8:00 PM
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Differential Effects of Iberdomide Versus Revlimid on Leukocyte Trafficking, Immune Activation and DLBCL Tumor Cell Killing |
Yumi Nakayama |
Oral Abstract #718
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622. Lymphomas: Translational-Non-Genetic: Lymphoma biology |
Monday, December 13, 3:30 PM |
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Completed Induction Phase Analysis of MAGNIFY: Phase 3b Study of Lenalidomide + Rituximab (R2) Followed By Maintenance in Relapsed/Refractory Indolent Non-Hodgkin Lymphoma |
Frederick Lansigan
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Oral Abstract #812
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623. Mantle Cell, Follicular, and Other B-Cell Lymphomas: Clinical and Epidemiological: Follicular Lymphoma: Advances in Treatment Approaches |
Monday, December 13, 4:45 PM
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Discovery and Preclinical Characterization of CC-95251, an Anti-SIRPa Antibody that Enhances Macrophage-Mediated Phagocytosis of Non-Hodgkin Lymphoma (NHL) Cells when Combined with Rituximab |
Henry Chan |
Poster Abstract #2271
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605. Molecular Pharmacology and Drug Resistance: Lymphoid Neoplasms: Poster II |
Monday, December 13, 6:00 – 8:00 PM
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Characteristics of Post-Infusion Chimeric Antigen Receptor (CAR) T Cells and Endogenous T Cells Associated with Early and Long-term Response in Lisocabtagene Maraleucel (liso-cel)–Treated Relapsed or Refractory (R/R) Large B-Cell Lymphoma (LBCL) |
Jerill Thorpe
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Poster Abstract #2417
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704. Cellular Immunotherapies: Clinical: Poster III |
Monday, December 13, 6:00 – 8:00 PM
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Two-Year Follow-up of TRANSCEND NHL 001, a Multicenter Phase 1 Study of Lisocabtagene Maraleucel (liso-cel) in Relapsed or Refractory (R/R) Large B-Cell Lymphomas (LBCL) |
Jeremy Abramson
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Poster Abstract #2840
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704. Cellular Immunotherapies: Clinical: Poster III |
Monday, December 13, 6:00 – 8:00 PM
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Cost-effectiveness of Liso-cel versus Axi-cel for Treatment of Relapsed or Refractory Large B-Cell Lymphoma |
Christopher Parker
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Poster Abstract #3003
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902. Health Services Research—Lymphoid Malignancies: Poster II |
Monday, December 13, 6:00 – 8:00 PM
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Clinical Activity of CC-99282, a Novel, Oral Small Molecule Cereblon E3 Ligase Modulator (CELMoD) Agent, in Patients (Pts) with Relapsed or Refractory Non-Hodgkin Lymphoma (R/R NHL) – First Results from a Phase 1, Open-Label Study |
Jean-Marie Michot |
Poster Abstract #3574 |
626. Aggressive Lymphomas: Prospective Therapeutic Trials: Poster III |
Monday, December 13, 6:00 – 8:00 PM |
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Multiple Myeloma |
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Iberdomide (IBER) in Combination with Dexamethasone (DEX) in Patients (pts) with Relapsed/Refractory Multiple Myeloma (RRMM): Results from the Dose-Expansion Phase of the CC-220-MM-001 Trial |
Sagar Lonial |
Oral Abstract #162 |
653. Myeloma and Plasma Cell Dyscrasias: Clinical-Prospective Therapeutic Trials: Novel Targets and Amyloid |
Saturday, December 11, 1:15 PM
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Real-World Treatment Patterns and Clinical, Economic, and Humanistic Burden in Triple-Class Refractory Multiple Myeloma: Analysis of the CONNECT® Multiple Myeloma (MM) Disease Registry​ |
Sundar Jagannath |
Oral Abstract #117 |
905. Outcomes Research- Lymphoid Malignancies: Multiple Myeloma and Other Plasma Cell Disorders ​ |
Saturday, December 11,​ 10:00 AM
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Baseline Correlates of Complete Response to Idecabtagene Vicleucel (ide-cel, bb2121), a BCMA-Directed CAR T Cell Therapy in Patients with Relapsed and Refractory Multiple Myeloma: Subanalysis of the KarMMa Trial |
Nina Shah |
Poster Abstract #1739
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704. Cellular Immunotherapies: Clinical: Poster I |
Saturday, December 11 5:30 – 7:30 PM |
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Matching-Adjusted Indirect Comparisons of Efficacy Outcomes in Patients with Relapsed and Refractory Multiple Myeloma for Idecabtagene Vicleucel (KarMMa) vs. Selinexor Plus Dexamethasone (STORM Part 2) and Belantamab Mafodontin (DREAMM-2): Updated Analysis with Longer Follow-up |
Paula Rodriguez-Otero |
Poster Abstract #1978
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905. Outcomes Research—Lymphoid Malignancies: Poster I |
Saturday, December 11, 5:30 – 7:30 PM
|
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Updated Clinical and Correlative Results From the Phase I CRB-402 Study of the BCMA-Targeted CAR-T Cell Therapy bb21217 in Patients with Relapsed and Refractory Multiple Myeloma |
Noopur Raje |
Oral Abstract #548
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Cellular Immunotherapies: Cellular Therapies for Myeloma |
Sunday, December 12 4:45 PM
|
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CC-92480, a Potent, Novel Cereblon E3 Ligase Modulator (CELMoD) Agent, in Combination with Dexamethasone (DEX) and Bortezomib (BORT) in Patients (pts) with Relapsed/Refractory Multiple Myeloma (RRMM): Preliminary Results from the Phase 1/2 Study CC-92480-MM-002 |
Paul Richardson |
Poster Abstract #2731 |
653. Myeloma and Plasma Cell Dyscrasias: Clinical-Prospective Therapeutic Trials: Poster II |
Sunday, December 12 6:00 – 8:00 PM |
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Subsequent Anti-myeloma Therapy after Idecabtagene Vicleucel (Ide-cel, bb2121) Treatment in Patients with Relapsed/Refractory Multiple Myeloma from the KarMMa Study |
Paula Rodriguez-Otero |
Poster Abstract #2743
|
653. Myeloma and Plasma Cell Dyscrasias: Clinical-Prospective Therapeutic Trials: Poster II |
Sunday, December 12 6:00 – 8:00 PM
|
|
Updated Health-Related Quality of Life Results from the KarMMa Clinical Study in Patients with Relapsed and Refractory Multiple Myeloma Treated with the B-Cell Maturation Antigen-Directed Chimeric Antigen Receptor T Cell Therapy Idecabtagene Vicleucel (ide-cel, bb2121) |
Michel Delforge |
Poster Abstract #2835 |
704. Cellular Immunotherapies: Clinical: Poster II |
Sunday, December 12, 6:00 – 8:00 PM |
|
Idecabtagene Vicleucel (ide-cel, bb2121), a B-Cell Maturation Antigen-Directed Chimeric Antigen Receptor T Cell Therapy: Qualitative Analyses of Post-Treatment Interviews (Months 6–24) for Patients with Relapsed and Refractory Multiple Myeloma in the KarMMa Clinical Trial |
Nina Shah |
Poster Abstract #3041 |
Session Name: 905. Outcomes Research—Lymphoid Malignancies: Poster II |
Sunday, December 12 6:00 – 8:00 PM |
|
Large-Scale Mass Cytometry Reveals Significant Activation of Innate and Adaptive Immunity in Bone Marrow Tumor Microenvironment of Iberdomide-Treated Myeloma Patients |
Oliver Van Oekelen |
Oral Abstract #730
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651. Multiple Myeloma and Plasma Cell Dyscrasias: Basic and Translational: The Myeloma Immune Microenvironment |
Monday, December 13, 3:30 PM |
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Myelodysplastic Syndrome |
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Treatment Duration and Exposure Adjusted Safety Analysis in the MEDALIST Study (luspatercept) |
Uwe Platzbecker |
Poster Abstract #1524 |
637. Myelodysplastic Syndromes — Clinical and Epidemiological: Poster I |
Saturday, December 11 5:30 – 7:30 PM |
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Myelofibrosis |
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Safety and Tolerability of Fedratinib, an Oral Inhibitor of Janus Kinase 2 (JAK2), in Patients with Intermediate- or High-risk Myelofibrosis (MF) Previously Treated with Ruxolitinib: Results from the Phase 3b FREEDOM Trial |
Vikas Gupta |
Oral Abstract #389 |
634. Myeloproliferative Syndromes: Clinical and Epidemiological: Novel Therapies for MPNs and JAK inhibitors for Myelofibrosis |
Sunday, December 12, 10:30 AM |
|
Spleen and Symptom Responses with Fedratinib (FEDR) Patients with Myelofibrosis (MF) and Substantial Splenomegaly |
Jeanâ€Jacques Kiladjian |
Poster Abstract #2576 |
634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster II |
Sunday, December 12 6:00 – 8:00 PM |
