On May 20, 2020 Bristol Myers Squibb (NYSE: BMY) reported the presentation of data across its hematology portfolio at the 25 th European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress, which will take place virtually from June 11-14, 2020 (Press release, Bristol-Myers Squibb, MAY 20, 2020, View Source [SID1234558306]). Data from nearly 60 company-sponsored studies will be featured, highlighting the company’s innovative approaches to treating blood cancers and other diseases.
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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 (Free EHA Whitepaper) 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 (Free EHA Whitepaper) 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.