Benzinga | Nov 4, 2021 10:17AM EDT

Bristol Myers Squibb To Highlight More Than 80 Abstracts At ASH 2021

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(r)s, with new safety and efficacy results for iberdomide and first presentation of combination data with CC-92480

First clinical results for anti-SIRP? antibody CC-95251 and CELMoD(r) 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-SIRP? antibody CC-95251 plus rituximab, as well as first clinical results for CELMoD(r) 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(r) 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(r) 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(r) (azacitidine tablets) from the Phase 3 QUAZAR(r) AML-001 study and safety with Inrebic(r) (fedratinib) from the Phase 3b FREEDOM trial in myelofibrosis

* Updated analyses of Reblozyl(r) (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:

Abstract Title Author Presentation Session Title Session Type/# Date/Time

Acute Myeloid Leukemia

Prognostic Impact of NPM1 and 617. Acute MyeloidFLT3 Mutations at Diagnosis and Leukemia: Biomarkers,Presence of Measurable Residual Molecular Markers and Monday,Disease (MRD) after Intensive Oral Minimal Residual Disease DecemberChemotherapy (IC) for Patients Hartmut Do:hner in Diagnosis and 13,with Acute Myeloid Leukemia (AML) Abstract # Prognosis: New options ofin Remission: Outcomes from the 804 risk assessment and 5:45 PMQUAZAR AML-001 Trial of Oral prediction of therapyAzacitidine (Oral-AZA) response in AMLMaintenance

Long-term Overall Survival (OS) 615. Acute Myeloidwith Oral Azacitidine (Oral-AZA) Leukemias: Commercially Monday,in Patients with Acute Myeloid Oral Available Therapies, DecemberLeukemia (AML) in First Remission Andrew Wei Excluding Transplantation 13,after Intensive Chemotherapy Abstract # and Cellular(IC): Updated Results from the 871 Immunotherapies: Updates 6:15 PMPhase 3 QUAZAR AML-001 Trial in treatment for high-risk AML

Beta Thalassemia

Oral Monday,Luspatercept Redistributes Body Maciej Abstract 102. Iron Homeostasis and DecemberIron to the Liver in Garbowski Biology: Disorders of Iron 13,Transfusion-Dependent-Thalassemia #761 and Heme and Novel(TDT) During Erythropoietic Treatments 5:30 PMResponse

Luspatercept Improves Monday,Health-Related Quality of Life December(HRQoL) Symptoms and RBC Antonis Poster 112. Thalassemia and 13,Transfusion Burden in Patients Kattamis Abstract # Globin Gene Regulation:with Non-Transfusion-Dependent 3081 Poster III 6:00 -?-thalassemia (NTDT) in the 8:00 PMBEYOND Trial

Graft vs. Host Disease

Overall Survival of PatientsTreated with Abatacept inCombination with a Calcineurin 722. Allogeneic Monday,Inhibitor and Methotrexate After Poster Transplantation: Acute and DecemberAllogeneic Hematopoietic Stem Leslie Kean Abstract # Chronic GVHD, Immune 13, 6:00Cell Transplantation - Analysis 3912 Reconstitution: Poster III ? 8:00 PMof the Center for InternationalBlood and Marrow TransplantResearch Database

Lymphoma

Lisocabtagene Maraleucel(liso-cel), a CD19-DirectedChimeric Antigen Receptor (CAR) T Saturday,Cell Therapy, Versus Standard of DecemberCare (SOC) with Salvage Oral 11,Chemotherapy (CT) Followed by Manali Kamdar Abstract 704. CellularAutologous Stem Cell Immunotherapies: Cellular 9:30 AMTransplantation (ASCT) as #91 Therapies for LymphomasSecond-Line (2L) Treatment in Patients (Pts) with Relapsed or Refractory (R/R) Large B-Cell Lymphoma (LBCL): Results from theRandomized Phase 3 TRANSFORMStudy

624. Hodgkin Lymphomas andRuxolitinib Plus Nivolumab in Oral T/NK cell Lymphomas:Patients with R/R Hodgkin Veronika Abstract Hodgkin Lymphoma Clinical Saturday,Lymphoma after Failure of Trials DecemberCheck-Point Inhibitors: Bachanova #230 11, 2:15Preliminary Report on Safety and Hematology Disease Topics PMEfficacy & Pathways:

Clinical Trials

Nivolumab First-Line Therapy for Oral Saturday,Elderly Hodgkin Lymphoma Julien Abstract 624. Hodgkin Lymphomas and DecemberPatients: a LYSA Phase II Study Lazarovici T/NK cell Lymphomas: 11, 2:45 #232 Hodgkin Lymphoma Clinical PM Trials

OUTREACH: Results from a Phase 2 Saturday,Study of Lisocabtagene Maraleucel Poster December(liso-cel) Administered as John Godwin Abstract 704. Cellular 11,Inpatient (Inpt) or Outpatient Immunotherapies: Clinical:(Outpt) Treatment in the #1762 Poster I 5:30 ?Nonuniversity Setting in Patients 7:30 PM(Pts) with R/R Large B-Cell Lymphoma (LBCL)

Sunday,Six-Year Results from the Phase 3 DecemberRandomized Study Relevance Show Poster 623. Mantle Cell, 12,Similar Outcomes for Previously Franck Abstract Follicular, and OtherUntreated Follicular Lymphoma Morschhauser Indolent B Cell Lymphomas: 6:00 -Patients Receiving Lenalidomide #2417 Clinical and 8:00 PMPlus Rituximab (R2) Versus Epidemiological: Poster IIRituximab-Chemotherapy Followed By Rituximab Maintenance

Differential Effects of Oral Monday,Iberdomide Versus Revlimid on Abstract 622. Lymphomas: DecemberLeukocyte Trafficking, Immune Yumi Nakayama Translational-Non-Genetic: 13,Activation and DLBCL Tumor Cell #718 Lymphoma biologyKilling 3:30 PM

Completed Induction Phase Oral 623. Mantle Cell, Monday,Analysis of MAGNIFY: Phase 3b Frederick Abstract Follicular, and Other DecemberStudy of Lenalidomide + Rituximab B-Cell Lymphomas: Clinical 13,(R2) Followed By Maintenance in Lansigan #812 and Epidemiological:Relapsed/Refractory Indolent Follicular Lymphoma: 4:45 PMNon-Hodgkin Lymphoma Advances in Treatment Approaches

Discovery and Preclinical Poster Monday,Characterization of CC-95251, an Abstract DecemberAnti-SIRPa Antibody that Enhances 605. Molecular 13,Macrophage-Mediated Phagocytosis Henry Chan #2271 Pharmacology and Drugof Non-Hodgkin Lymphoma (NHL) Resistance: Lymphoid 6:00 -Cells when Combined with Neoplasms: Poster II 8:00 PMRituximab

Characteristics of Post-Infusion Monday,Chimeric Antigen Receptor (CAR) T Poster DecemberCells and Endogenous T Cells Abstract 13,Associated with Early and Jerill Thorpe 704. CellularLong-term Response in #2417 Immunotherapies: Clinical: 6:00 -Lisocabtagene Maraleucel Poster III 8:00 PM(liso-cel)?Treated Relapsed or Refractory (R/R) Large B-Cell Lymphoma (LBCL)

Monday,Two-Year Follow-up of TRANSCEND Poster DecemberNHL 001, a Multicenter Phase 1 Jeremy Abramson Abstract 704. Cellular 13,Study of Lisocabtagene Maraleucel Immunotherapies: Clinical:(liso-cel) in Relapsed or #2840 Poster III 6:00 -Refractory (R/R) Large B-Cell 8:00 PMLymphomas (LBCL)

Monday, Poster DecemberCost-effectiveness of Liso-cel Christopher Abstract 902. Health Services 13,versus Axi-cel for Treatment of Parker Research?LymphoidRelapsed or Refractory Large #3003 Malignancies: Poster II 6:00 -B-Cell Lymphoma 8:00 PM

Clinical Activity of CC-99282, aNovel, Oral Small Molecule Monday,Cereblon E3 Ligase Modulator Poster 626. Aggressive Lymphomas: December(CELMoD) Agent, in Patients (Pts) Jean-Marie Abstract Prospective Therapeutic 13,with Relapsed or Refractory Michot Trials: Poster III Non-Hodgkin Lymphoma (R/R NHL) ? #3574 6:00 -First Results from a Phase 1, 8:00 PMOpen-Label Study

Multiple Myeloma

Iberdomide (IBER) in Combination Saturday,with Dexamethasone (DEX) in 653. Myeloma and Plasma DecemberPatients (pts) with Relapsed/ Oral Cell Dyscrasias: 11, 1:15Refractory Multiple Myeloma Sagar Lonial Abstract # Clinical-Prospective PM(RRMM): Results from the 162 Therapeutic Trials: NovelDose-Expansion Phase of the Targets and Amyloid CC-220-MM-001 Trial

Real-World Treatment Patterns and Saturday,Clinical, Economic, and Oral 905. Outcomes Research- DecemberHumanistic Burden in Triple-Class Sundar Abstract Lymphoid Malignancies: 11,?Refractory Multiple Myeloma: Jagannath Multiple Myeloma and OtherAnalysis of the CONNECT(R) #117 Plasma Cell Disorders ? 10:00 AMMultiple Myeloma (MM) DiseaseRegistry?

Baseline Correlates of Complete PosterResponse to Idecabtagene Abstract Saturday,Vicleucel (ide-cel, bb2121), a 704. Cellular DecemberBCMA-Directed CAR T Cell Therapy Nina Shah #1739 Immunotherapies: Clinical: 11 5:30 -in Patients with Relapsed and Poster I 7:30 PMRefractory Multiple Myeloma: Subanalysis of the KarMMa Trial

Matching-Adjusted Indirect Saturday,Comparisons of Efficacy Outcomes Poster Decemberin Patients with Relapsed and Abstract 11,Refractory Multiple Myeloma for Paula 905. OutcomesIdecabtagene Vicleucel (KarMMa) Rodriguez-Otero #1978 Research?Lymphoid 5:30 ?vs. Selinexor Plus Dexamethasone Malignancies: Poster I 7:30 PM(STORM Part 2) and Belantamab Mafodontin (DREAMM-2): Updated Analysis with Longer Follow-up

Sunday,Updated Clinical and Correlative DecemberResults From the Phase I CRB-402 Oral 12Study of the BCMA-Targeted CAR-T Abstract # Cellular Immunotherapies:Cell Therapy bb21217 in Patients Noopur Raje 548 Cellular Therapies for 4:45 PMwith Relapsed and Refractory MyelomaMultiple Myeloma



CC-92480, a Potent, NovelCereblon E3 Ligase Modulator Sunday,(CELMoD) Agent, in Combination Poster 653. Myeloma and Plasma Decemberwith Dexamethasone (DEX) and Abstract Cell Dyscrasias: 12Bortezomib (BORT) in Patients Paul Richardson Clinical-Prospective(pts) with Relapsed/Refractory #2731 Therapeutic Trials: Poster 6:00 -Multiple Myeloma (RRMM): II 8:00 PMPreliminary Results from thePhase 1/2 Study CC-92480-MM-002

Subsequent Anti-myeloma Therapy Poster 653. Myeloma and Plasma Sunday,after Idecabtagene Vicleucel Abstract Cell Dyscrasias: December(Ide-cel, bb2121) Treatment in Paula Clinical-Prospective 12 6:00 ?Patients with Relapsed/Refractory Rodriguez-Otero #2743 Therapeutic Trials: Poster 8:00 PMMultiple Myeloma from the KarMMa IIStudy

Updated Health-Related Quality ofLife Results from the KarMMaClinical Study in Patients with Poster Sunday,Relapsed and Refractory Multiple Abstract 704. Cellular DecemberMyeloma Treated with the B-Cell Michel Delforge Immunotherapies: Clinical: 12, 6:00Maturation Antigen-Directed #2835 Poster II ? 8:00 PMChimeric Antigen Receptor T CellTherapy Idecabtagene Vicleucel(ide-cel, bb2121)

Idecabtagene Vicleucel (ide-cel,bb2121), a B-Cell MaturationAntigen-Directed Chimeric Antigen Poster Sunday,Receptor T Cell Therapy: Abstract Session Name: 905. DecemberQualitative Analyses of Nina Shah Outcomes Research?Lymphoid 12 6:00 ?Post-Treatment Interviews (Months #3041 Malignancies: Poster II 8:00 PM6?24) for Patients with Relapsedand Refractory Multiple Myelomain the KarMMa Clinical Trial

Large-Scale Mass Cytometry OralReveals Significant Activation of Abstract 651. Multiple Myeloma and Monday,Innate and Adaptive Immunity in Oliver Van Plasma Cell Dyscrasias: DecemberBone Marrow Tumor Oekelen #730 Basic and Translational: 13, 3:30Microenvironment of The Myeloma Immune PMIberdomide-Treated Myeloma MicroenvironmentPatients

Myelodysplastic Syndrome

Treatment Duration and Exposure Poster 637. Myelodysplastic Saturday,Adjusted Safety Analysis in the Uwe Platzbecker Abstract Syndromes ? Clinical and DecemberMEDALIST Study (luspatercept) Epidemiological: Poster I 11 5:30 - #1524 7:30 PM

Myelofibrosis

Safety and Tolerability ofFedratinib, an Oral Inhibitor of 634. MyeloproliferativeJanus Kinase 2 (JAK2), in Oral Syndromes: Clinical and Sunday,Patients with Intermediate- or Vikas Gupta Abstract Epidemiological: Novel DecemberHigh-risk Myelofibrosis (MF) Therapies for MPNs and JAK 12, 10:30Previously Treated with #389 inhibitors for AMRuxolitinib: Results from the MyelofibrosisPhase 3b FREEDOM Trial

Spleen and Symptom Responses with Poster 634. Myeloproliferative Sunday,Fedratinib (FEDR) Patients with Jean?Jacques Abstract Syndromes: Clinical and DecemberMyelofibrosis (MF) and Kiladjian Epidemiological: Poster II 12 6:00 -Substantial Splenomegaly #2576 8:00 PM