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

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

Wednesday, May 20, 2020 6:59 am EDT

Dateline:

PRINCETON, N.J.

Public Company Information:

NYSE:
BMY

$BMY to present data from nearly 60 company-sponsored studies across multiple blood diseases at #EHA25Virtual

PRINCETON, N.J.--(BUSINESS WIRE)--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 25th 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.

Cautionary Statement Regarding Forward-Looking Statements

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 historical performance and 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. 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, 2019, 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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