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Bristol Myers Squibb to Highlight More than 80 Abstracts at ASH 2021 Demonstrating Strength of Innovative Therapeutic Platforms Improving Outcomes for a Broad Range of Hematologic Diseases

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

PRINCETON, N.J.–(BUSINESS WIRE)–$BMY #ASH21Bristol 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:

“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:

Abstract Title

Author

Presentation Type/#

Session Title

Session Date/Time

Acute Myeloid Leukemia

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

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

Beta Thalassemia

Luspatercept Redistributes Body Iron to the Liver in Transfusion-Dependent-Thalassemia (TDT) During Erythropoietic Response

Maciej Garbowski

 

Oral Abstract

#761

 

102. Iron Homeostasis and Biology: Disorders of Iron and Heme and Novel Treatments 

Monday, December 13,

5:30 PM

 

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

Graft vs. Host Disease

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

Lymphoma

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

 

704. Cellular Immunotherapies: Cellular Therapies for Lymphomas

Saturday, December 11,

9:30 AM

 

 

Ruxolitinib Plus Nivolumab in Patients with R/R Hodgkin Lymphoma after Failure of Check-Point Inhibitors: Preliminary Report on Safety and Efficacy

Veronika

Bachanova

 

Oral Abstract

#230

 

624. Hodgkin Lymphomas and T/NK cell Lymphomas: Hodgkin Lymphoma Clinical Trials

Hematology Disease Topics & Pathways:

Clinical Trials

Saturday, December 11, 2:15 PM

Nivolumab First-Line Therapy for Elderly Hodgkin Lymphoma Patients: a LYSA Phase II Study

 

Julien Lazarovici

 

Oral Abstract

#232

 

624. Hodgkin Lymphomas and T/NK cell Lymphomas: Hodgkin Lymphoma Clinical Trials

Saturday, December 11, 2:45 PM

 

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

 

Poster Abstract

#1762

 

704. Cellular Immunotherapies: Clinical: Poster I

Saturday, December 11,

5:30 – 7:30 PM

 

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

 

Poster Abstract

#2417

 

623. Mantle Cell, Follicular, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster II

Sunday, December 12,

6:00 – 8:00 PM

 

 

Differential Effects of Iberdomide Versus Revlimid on Leukocyte Trafficking, Immune Activation and DLBCL Tumor Cell Killing

Yumi Nakayama

Oral Abstract

#718

 

622. Lymphomas: Translational-Non-Genetic: Lymphoma biology

Monday, December 13,

3:30  PM

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

 

Oral Abstract

#812

 

623. Mantle Cell, Follicular, and Other B-Cell Lymphomas: Clinical and Epidemiological: Follicular Lymphoma: Advances in Treatment Approaches

Monday, December 13,

4:45 PM

 

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

 

 

605. Molecular Pharmacology and Drug Resistance: Lymphoid Neoplasms: Poster II

Monday, December 13,

6:00 – 8:00 PM

 

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

 

Poster Abstract

#2417

 

704. Cellular Immunotherapies: Clinical: Poster III

Monday, December 13,

6:00 – 8:00 PM

 

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

 

Poster Abstract

#2840

 

704. Cellular Immunotherapies: Clinical: Poster III

Monday, December 13,

6:00 – 8:00 PM

 

Cost-effectiveness of Liso-cel versus Axi-cel for Treatment of Relapsed or Refractory Large B-Cell Lymphoma

Christopher Parker

 

Poster Abstract

#3003

 

902. Health Services Research—Lymphoid Malignancies: Poster II

Monday, December 13,

6:00 – 8:00 PM

 

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

Multiple Myeloma

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

 

 

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

 

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

 

704. Cellular Immunotherapies: Clinical: Poster I

Saturday, December 11 5:30 – 7:30 PM

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

 

905. Outcomes Research—Lymphoid Malignancies: Poster I

Saturday, December 11,

5:30 – 7:30 PM

 

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

 

Cellular Immunotherapies: Cellular Therapies for Myeloma

Sunday, December 12

4:45 PM

 

 

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

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

 

651. Multiple Myeloma and Plasma Cell Dyscrasias: Basic and Translational: The Myeloma Immune Microenvironment

Monday, December 13, 3:30 PM

Myelodysplastic Syndrome

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 

Myelofibrosis

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

Jean‐Jacques Kiladjian

Poster Abstract

#2576 

634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster II

Sunday, December 12 6:00 – 8:00 PM

Bristol Myers Squibb: Creating a Better Future for Cancer Patients

Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine, and through innovative digital platforms, are turning data into insights that sharpen their focus. Deep scientific expertise, cutting-edge capabilities and discovery platforms enable the company to look at cancer from every angle. Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. Because as a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.

BREYANZI

Breyanzi is a CD19-directed chimeric antigen receptor (CAR) T cell therapy with a defined composition and 4-1BB costimulatory domain. Breyanzi is administered as a defined composition to reduce variability of the CD8 and CD4 component dose. The 4-1BB signaling domain enhances the expansion and persistence of the CAR T cells.

Indications

Breyanzi is approved by the U.S. Food and Drug Administration for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B. Breyanzi is also approved in Japan for the treatment of patients with R/R LBCL and follicular lymphoma.

U.S. Important Safety Information

BOXED WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITIES

Cytokine Release Syndrome (CRS)

CRS, including fatal or life-threatening reactions, occurred following treatment with BREYANZI. CRS occurred in 46% (122/268) of patients receiving BREYANZI, including ≥ Grade 3 (Lee grading system) CRS in 4% (11/268) 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 119 of 122 patients (98%) with a median duration of 5 days (range: 1 to 17 days). Median duration of CRS was 5 days (range 1 to 30 days) in all patients, including those who died or had CRS ongoing at time of death.

Among patients with CRS, the most common manifestations of CRS include fever (93%), hypotension (49%), tachycardia (39%), chills (28%), and hypoxia (21%). 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. Sixty-one of 268 (23%) patients received tocilizumab and/or a corticosteroid for CRS after infusion of BREYANZI. Twenty-seven (10%) patients received tocilizumab only, 25 (9%) received tocilizumab and a corticosteroid, and 9 (3%) received corticosteroids only.

Neurologic Toxicities

Neurologic toxicities that were fatal or life-threatening, occurred following treatment with BREYANZI. CAR T cell-associated neurologic toxicities occurred in 35% (95/268) of patients receiving BREYANZI, including ≥ Grade 3 in 12% (31/268) of patients. Three patients had fatal neurologic toxicity and 7 had ongoing neurologic toxicity at time of death. The median time to onset of the first event was 8 days (range: 1 to 46 days). The onset of all neurologic events occurred within the first 8 weeks following BREYANZI infusion. Neurologic toxicities resolved in 81 of 95 patients (85%) with a median duration of 12 days (range: 1 to 87 days). Three of four patients with ongoing neurologic toxicity at data cutoff had tremor and one subject had encephalopathy. Median duration of neurologic toxicity was 15 days (range: 1 to 785 days) in all patients, including those with ongoing neurologic events at the time of death or at data cutoff.

Seventy-eight (78) of 95 (82%) patients with neurologic toxicity experienced CRS. Neurologic toxicity overlapped with CRS in 57 patients. The onset of neurologic toxicity was after onset of CRS in 30 patients, before CRS onset in 13 patients, same day as CRS onset in 7 patients, and same day as CRS resolution in 7 patients.

Neurologic toxicity resolved in three patients before the onset of CRS. Eighteen patients experienced neurologic toxicity after resolution of CRS.

The most common neurologic toxicities included encephalopathy (24%), tremor (14%), aphasia (9%), delirium (7%), headache (7%), dizziness (6%), and ataxia (6%). Serious events including cerebral edema and seizures occurred with BREYANZI. Fatal and serious cases of leukoencephalopathy, some attributable to fludarabine, have occurred in patients treated with BREYANZI.

CRS and Neurologic Toxicities Monitoring

Monitor patients daily at a certified healthcare facility during the first week following infusion, for signs and symptoms of CRS and neurologic toxicities. Monitor patients for signs and symptoms of CRS and neurologic toxicities for at least 4 weeks after infusion; evaluate and treat promptly. Counsel patients to seek immediate medical attention should signs or symptoms of CRS or neurologic toxicity occur at any time. At the first sign of CRS, institute treatment with supportive care, tocilizumab or tocilizumab and corticosteroids as indicated.

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 infusion. Infections (all grades) occurred in 45% (121/268) of patients. Grade 3 or higher infections occurred in 19% of patients. Grade 3 or higher infections with an unspecified pathogen occurred in 16% of patients, bacterial infections occurred in 5%, and viral and fungal infections occurred in 1.5% and 0.

Contacts

Bristol Myers Squibb

Media Inquiries:
media@bms.com
609-252-3345

Investors:
Tim Power

609-252-7509

timothy.power@bms.com

Nina Goworek

908-673-9711

nina.goworek@bms.com

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