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Bristol Myers Squibb Research at EHA 2020 Demonstrates Continued Advances Across Multiple Blood Diseases

May 20, 2020 Off By BusinessWire

Data from multiple studies, including results in the outpatient administration setting and using machine learning technology, evaluating potential of CAR T liso-cel in relapsed and refractory large b-cell lymphoma

Data evaluating CC-486 as maintenance therapy that improves overall survival in acute myeloid leukemia, including analysis of Health-Related Quality of Life

Longer-term efficacy and safety analyses for Reblozyl in beta thalassemia from Phase 3 BELIEVE study

Pivotal data from KarMMa study on ide-cel, a potential first-in-class BCMA CAR T being developed with bluebird bio in triple-class exposed, relapsed and refractory multiple myeloma patients

PRINCETON, N.J.–(BUSINESS WIRE)–$BMY #BELIEVE—Bristol Myers Squibb (NYSE: BMY) today announced the presentation of data across its hematology portfolio at the 25 ^th European Hematology Association (EHA) Annual Congress, which will take place virtually from June 11-14, 2020. Data from nearly 60 company-sponsored studies will be featured, highlighting the company’s innovative approaches to treating blood cancers and other diseases.

In relapsed and refractory large B-cell lymphoma, key studies include analyses evaluating the potential of lisocabtagene maraleucel (liso-cel) treatment in the outpatient setting and data demonstrating the use of machine learning.

In leukemia and myeloid diseases, additional analyses from the QUAZAR AML-001 pivotal Phase 3 study evaluating CC-486 maintenance therapy in acute myeloid leukemia will be presented, in addition to efficacy and safety analyses from the Phase 3 BELIEVE and MEDALIST studies of Reblozyl, a potential first-in-class erythroid maturation agent (EMA) in Europe, in beta thalassemia and lower-risk myelodysplastic syndromes associated anemias, respectively.

In multiple myeloma, pivotal trial results from the KarMMa study of idecabtagene vicleucel (ide-cel; bb2121), a potential first-in-class B-cell maturation antigen (BCMA) -directed chimeric antigen receptor (CAR) T in multiple myeloma being developed with bluebird bio, will be presented, supporting its potential in heavily pre-treated patients with relapsed and refractory multiple myeloma (RRMM). These include translational and correlative data regarding BCMA expression, response and relapse, and analyses on Quality of Life, outcomes and healthcare utilization in patients with RRMM. Updated data from the EVOLVE Phase 1 study of orva-cel (orvacabtagene autoleucel), a fully human BCMA CAR T being developed by Juno Therapeutics, a Bristol-Myers Squibb company, in heavily pre-treated multiple myeloma patients will also be presented. Additionally, clinical data assessing the safety and efficacy of CC-93269, a 2+1 BCMA T cell engager (TCE), will be presented in patients with heavily pre-treated RRMM, as well as data for CC-92480, a novel CELMoD agent evaluated in combination with dexamethasone in patients with RRMM.

“Although we are not able to gather together in person at EHA this year, we still look forward to presenting data on therapeutic approaches that reinforce our commitment to advancing potential treatment options for people living with difficult-to-treat blood diseases,” said Samit Hirawat, M.D., executive vice president, chief medical officer, global drug development, Bristol Myers Squibb. “These data, spanning a diverse range of blood diseases provide new and important insights into the potential of our therapies in areas of high unmet need.”

Summary of Presentations:

Selected Bristol Myers Squibb studies at the 25^th EHA Virtual Annual Congress include:

Beta Thalassemia

Assessment of Longer-Term Efficacy and Safety in the Phase 3 BELIEVE Trial of Luspatercept to Treat Anemia in Patients (Pts) with β-Thalassemia

Author: Taher

Abstract: EP1548

Poster Session: Thalassemias

Assessment of Response to Luspatercept by β-Globin Genotype in Adult Patients with β-Thalassemia in the BELIEVE Trial

Author: Cappellini

Abstract: S295

Oral Session: New therapeutic approaches for thalassemia

Leukemia

CC-486 Maintenance Therapy is Safe and Well Tolerated in Patients Aged ≥75 Years with Acute Myeloid Leukemia (AML) in First Remission Following Induction Chemotherapy: Results from QUAZAR AML-001

Author: Ravandi

Abstract: EP550

Poster Session: Acute myeloid leukemia – Clinical

Health-Related Quality of Life with CC-486 in Patients with Acute Myeloid Leukemia (AML) in First Remission Following Induction Chemotherapy (IC): Results from the Phase 3 QUAZAR AML-001 TRIAL

Author: Roboz

Abstract: S334

Oral Session: Integrating the patients’ voice in hematology

Lymphoma

Lisocabtagene Maraleucel for Treatment of Second-Line Transplant Noneligible Relapsed/Refractory Aggressive Large B-Cell Non-Hodgkin Lymphoma: Updated Results from the PILOT Study

Author: Ghosh

Abstract: S244

Oral Session: Aggressive Lymphomas: Cellular and bispecific antibody therapies

Multivariate Supervised Learning of Lisocabtagene Maraleucel (Liso-Cel) CAR T Cell Product and Patient Characteristics Identifies Attributes Associated with Clinical Endpoints in Large B-Cell Lymphoma

Author: Jiang

Abstract: S275

Oral Session: Session: Immunotherapy – Translational

Outpatient Treatment with Lisocabtagene Maraleucel (Liso-Cel) Across a Variety of Clinical Sites from Three Ongoing Clinical Studies in Relapsed/Refractory Large B-Cell Lymphoma

Author: Bachier

Abstract: EP1212

Poster Session: Aggressive Non-Hodgkin lymphoma – Clinical

Response-Adapted Therapy with Nivolumab + Brentuximab Vedotin in Children, Adolescents, and Young Adults with Standard-Risk Relapsed/Refractory Classical Hodgkin Lymphoma: CheckMate 744

Author: Mauz-Körholz

Abstract: S224

Oral Session: Hodgkin lymphoma – Clinical

Multiple Myeloma

A Systematic Literature Review to Assess Efficacy of Treatments in Triple-Class Exposed Relapsed and Refractory Multiple Myeloma Patients

Author: Davies

Abstract: EP1030

Poster Session: Myeloma and other monoclonal gammopathies – Clinical

Baseline and Postinfusion Pharmcodynamic Biomarkers of Safety and Efficacy in Patients Treated with Idecabtagene Vicleucel (Ide-cel; Bb2121) in the KarMMa Study

Author: Dell’Aringa

Abstract: EP959

Poster Session: Myeloma and other monoclonal gammopathies – Clinical

CC-93269, a 2+1 T Cell Engager (TCE) Targeting B-Cell Maturation Antigen (BCMA) and CD3ε, Shows Antitumor Activity in Multiple Myeloma Preclinical Models

Author: Van der Vuurst de Vries

Abstract: S198

Oral Session: Myeloma biology and translational research

Correlation of Tumor BCMA Expression with Response and Acquired Resistance to Idecabtagene Vicleucel in the KarMMa Study in Relapsed and Refractory Multiple Myeloma

Author: Martin

Abstract: EP985

Poster Session: Myeloma and other monoclonal gammopathies – Clinical

First-in-Human Phase 1 Study of the Novel CELMoD Agent CC-92480 Combined with Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma

Author: Richardson

Abstract: S208

Oral Session: Management of relapsed/refractory multiple myeloma and minimal residual disease assessment

Interim Results from the First Phase I Clinical Study of the B-Cell Maturation Antigen (BCMA) 2+1 T Cell Engager (TCE) CC-93269 in Patients (Pts) with Relapsed/Refractory Multiple Myeloma (RRMM)

Author: Costa

Abstract: S205

Oral Session: Management of relapsed/refractory multiple myeloma and minimal residual disease assessment

Matching-Adjusted Indirect Comparisons of Efficacy Outcomes for Idecabtagene Vicleucel from the KarMMa Study vs Selinexor Plus Dexamethasone (STORM Part 2) and Belantamab Mafodotin (DREAMM-2)

Author: Rodriguez-Otero

Abstract: EP969

Poster Session: Myeloma and other monoclonal gammopathies – Clinical

Orvacabtagene Autoleucel (Orva-Cel), a B-Cell Maturation Antigen-Directed CAR T Cell Therapy for Patients with Relapsed/Refractory Multiple Myeloma: Update of the Phase 1/2 EVOLVE Study

Author: Mailankody

Abstract: EP927

Poster Session: Myeloma and other monoclonal gammopathies – Clinical

Idecabtagene Vicleucel (Ide-Cel; Bb2121), a BCMA-Targeted CAR T Cell Therapy, in Patients with Relapsed and Refractory Multiple Myeloma: Initial KarMMa Results

Author: San Miguel

Abstract: S209

Oral Session: Management of relapsed/refractory multiple myeloma and minimal residual disease assessment

Quality of Life in Patients with Relapsed and Refractory Multiple Myeloma Treated with the BCMA-Targeted CAR T Cell Therapy Idecabtagene Vicleucel (Ide-Cel; Bb2121): Results from the KarMMa Trial

Author: Delforge

Abstract: EP1000

Poster Session: Myeloma and other monoclonal gammopathies – Clinical

Recent Treatment Patterns, Healthcare Utilization, and Costs in Heavily Pretreated Relapsed and/or Refractory Multiple Myeloma Patients in the United states

Author: Chari

Abstract: EP1756

Poster Session: Quality of life, palliative & supportive care, ethics and health economics

Myelodysplastic Syndromes

Assessment of Dose-Dependent Response to Luspatercept in Patients (Pts) with Lower-Risk Myelodysplastic Syndromes (LR-MDS) with Ring Sideroblasts in the Phase 3 MEDALIST Trial

Author: Platzbecker

Abstract: EP812

Poster Session: Myelodysplastic syndromes – Clinical

A Phase III Placebo-Controlled Trial of CC-486 in Patients with Red Blood Cell Transfusion-Dependent (RBC-TD) Anemia and Thrombocytopenia due to IPSS Lower-Risk Myelodysplastic Syndromes (LR-MDS)

Author: Garcia-Manero

Abstract: S180

Oral Session: Novel treatments for MDS I

Effects of Luspatercept on Serum Ferritin in Patients (Pts) with Lower-Risk Myelodysplastic Syndromes (MDS) with Ring Sideroblasts (RS) in the Phase 3 MEDALIST Trial

Author: Fenaux

Abstract: EP807

Oral Session: Myelodysplastic syndromes – Clinical

Myelofibrosis

Early Onset of Spleen and Symptom Responses with Fedratinib (FEDR) in Patients with Intermediate- or High-Risk Myelofibrosis (MF)

Author: Passamonti

Abstract: EP1109

Poster Session: Myeloproliferative neoplasms – Clinical

Bristol Myers Squibb: Advancing Cancer Research

At Bristol Myers Squibb, patients are at the center of everything we do. The goal of our cancer research is to increase patients’ quality of life, long-term survival and make cure a possibility. We harness our deep scientific experience, cutting-edge technologies and discovery platforms to discover, develop and deliver novel treatments for patients.

Building upon our transformative work and legacy in hematology and Immuno-Oncology that has changed survival expectations for many cancers, our researchers are advancing a deep and diverse pipeline across multiple modalities. In the field of immune cell therapy, this includes registrational chimeric antigen receptor (CAR) T-cell agents for numerous diseases, and a growing early-stage pipeline that expands cell and gene therapy targets, and technologies. We are developing cancer treatments directed at key biological pathways using our protein homeostasis platform, a research capability that has been the basis of our approved therapies for multiple myeloma and several promising compounds in early to mid-stage development. Our scientists are targeting different immune system pathways to address interactions between tumors, the microenvironment and the immune system to further expand upon the progress we have made and help more patients respond to treatment. Combining these approaches is key to delivering potential new options for the treatment of cancer and addressing the growing issue of resistance to immunotherapy. We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines a reality 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, Twitter, YouTube, Facebook and Instagram.

Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol-Myers Squibb Company. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol-Myers Squibb company and Juno Therapeutics, a Bristol-Myers Squibb company.

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