AbbVie Highlights Blood Cancer Data From Its Growing Oncology Pipeline at the 64th ASH Annual Meeting

 

-       Nearly 65 abstracts, including 15 oral presentations on 7 investigational and approved medicines across 8 cancer types, to be presented at the American Society of Hemaotology (ASH) annual congress

NORTH CHICAGO, Ill., Nov. 22, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) will present results from nearly 65 company and partner abstracts across 8 types of cancer during the upcoming American Society of Hematology (ASH) annual meeting (December 10-13) in New Orleans, Louisiana.

"Our latest research is driven by our commitment to help improve the health and lives of people living with blood cancers," said Mohamed Zaki, M.D., Ph.D., vice president and global head of oncology development, AbbVie. "The data we are presenting at the ASH annual congress represents progress in our expanding hematology oncology portfolio and the potential to help address more blood cancer patient needs in the future."

At ASH, AbbVie will present the latest data for investigational and approved blood cancer therapies including: 

  • investigational medicine epcoritamab (an anti-CD20 x CD3 bispecific antibody) in partnership with Genmab for Non-Hodgkins Lymphomas including Large B-Cell Lymphoma (LBCL) and Follicular Lymphoma (FL);
  • investigational navitoclax in combination with ruxolitinib in JAK inhibitor-naïve patients with Myelofibrosis (MF);
  • new data from the Phase 2 CAPTIVATE and Phase 3 GLOW studies evaluating residual disease and disease-free survival outcomes in Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Leukemia (SLL) patients who received the investigational ibrutinib (IMBRUVICA®) + venetoclax (VENCLEXTA®) combination;
  • multiple abstracts evaluating venetoclax in approved CLL and Acute Myeloid Leukemia (AML) indications and an investigational Multiple Myeloma (MM) indication.

Data presentation details include:

ASH 2022 Abstracts

Abstract

Presentation Details

All Times in CT

Ibrutinib

Treatment Outcomes After Undetectable MRD With
First-Line Ibrutinib (Ibr) Plus Venetoclax (Ven): Fixed
Duration Treatment (Placebo) Versus Continued Ibr
With Up to 5 Years Median Follow-up in the
CAPTIVATE Study

Session: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Targeted Doublet Combinations

Saturday, December 10, 2022

9:45 a.m. CT

Oral Presentation

Residual Disease Dynamics Among Patients with
Unmutated IGHV or TP53 Mutations Treated with First-
Line Fixed-Duration Ibrutinib plus Venetoclax (Ibr+Ven)
versus Chlorambucil plus Obinutuzumab (Clb+O): the
GLOW Study

Session: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Targeted Doublet Combinations

Saturday, December 10, 2022

10:00 a.m. CT

Oral Presentation

Real-World Comparison of Time to Next Treatment
Between Patients Initiated on Single-Agent Ibrutinib or
Acalabrutinib in First Line

Session: Outcomes Research—Lymphoid Malignancies: Outcomes in Lymphoma
Monday, December 12, 2022

11:30 a.m. CT

Oral Presentation

Initiating Firstline (1L) Ibrutinib (Ibr) in Chronic
Lymphocytic Leukemia (CLL) Patients (pts) Improves
Overall Survival (OS) Outcomes to Rates Approximating
an Age-Matched Population of ≥ 65 Years

Session: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster I

Saturday, December 10, 2022

5:30 - 7:30 p.m. CT

Poster Presentation

Real-World Outcomes With First-Line Ibrutinib (Ibr)
Versus Chemoimmunotherapy (CIT) in Patients With
Chronic Lymphocytic Leukemia (CLL)/Small
Lymphocytic Lymphoma (SLL): Final Analysis Results
From the informCLL Registry

Session: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster II

Presentation

Sunday, December 11, 2022

6:00 - 8:00 p.m. CT

Poster Presentation

Early Adherence and Persistence to First-Line Ibrutinib
or Acalabrutinib Among Patients with Chronic
Lymphocytic Leukemia/Small Lymphocytic Lymphoma
and Atrial Fibrillation

Session: Outcomes Research—Lymphoid Malignancies: Poster III

Monday, December 12, 2022

6:00 - 8:00 p.m. CT

Poster Presentation

Real World Treatment Patterns in Patients with Chronic
Lymphocytic Leukemia and Small Lymphocytic
Lymphoma Switching From First Line Ibrutinib to
Acalabrutinib Monotherapy

Session: Outcomes Research—Lymphoid Malignancies: Poster II

Session Date/Time: Sunday, December 11, 2022

6:00 - 8:00 p.m. CT

Poster Presentation

Ibrutinib Plus Bendamustine Plus Rituximab and
Rituximab Maintenance (I+BR) Versus Rituximab,
Cyclophosphamide, Doxorubicin, Vincristine,
Prednisone Regimen (R-CHOP) and Rituximab,
Cyclophosphamide, Doxorubicin, Bortezomib,
Prednisone Regimen (VR-CAP) in First-Line Mantle Cell 
Lymphoma Patients: An Adjusted Treatment
Comparison Using Inverse Probability Weighting

Session: Mantle Cell, Follicular, and Other Indolent B Cell Lymphomas:
Clinical and Epidemiological: Poster I

Presentation

Saturday, December 10, 2022

5:30 - 7:30 p.m. CT

Poster Presentation

Effectiveness and Safety of Ibrutinib in Patients with
Mantle Cell Lymphoma (MCL) in Belgian Routine
Clinical Practice: 3-Year Follow-up

Session: Mantle Cell, Follicular, and Other Indolent B Cell Lymphomas:
Clinical and Epidemiological: Poster I

Presentation

Saturday, December 10, 2022

5:30 - 7:30 p.m. CT

Poster Presentation

External Validation of the FLIPI Risk Score Measured at
Initial Diagnosis and POD24 among Previously Treated
Individuals with Progressed Follicular Lymphoma in
Alberta, Canada

Session: Outcomes Research—Lymphoid Malignancies: Poster II Presentation

Sunday, December 11, 2022

6:00 - 8:00 p.m. CT

Poster Presentation

FIRE: Overall and Subgroup Results from the Third
Interim Analysis of FIRE, a Real-World Study of Ibrutinib
Treatment for CLL/SLL in France

Session: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster III Presentation

Monday, December 12, 2022

6:00 - 8:00 p.m. CT

Poster Presentation

Use of Ibrutinib in Real Life Settings in France: results
from a retrospective Observational Study using the
SNDS database (OSIRIS)

Session: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster III

Monday, December 12, 2022

6:00 PM-8:00 PM
Poster Presentation

Real-World Outcome of Treatment with Single-Agent
Ibrutinib in Patients with Chronic Lymphocytic Leukemia:
Results from the Italian Study Evidence

Session: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster I Presentation

Saturday, December 10, 2022

5:30 - 7:30 p.m. CT

Poster Presentation

Real-world Outcomes with Ibrutinib in Patients with
Chronic Lymphocytic Leukemia: Impact of Patient
Typology on Adherence and Retention Rates within the
German REALITY Study

Abstract Publication Only

Venetoclax

Long-Term Follow-Up of the Phase 3 VIALE-A Clinical
Trial of Venetoclax Plus Azacitidine for Patients with
Untreated Acute Myeloid Leukemia Ineligible for
Intensive Chemotherapy

Session: Acute Myeloid Leukemias: Commercially Available Therapies,
Excluding Transplantation and Cellular Immunotherapies: New Approaches
to Combination Chemotherapy and Venetoclax Plus Hypomethylating Agent Therapy in AML

Saturday, December 10, 2022

2:30 p.m. CT

Oral Presentation

ELN Risk Stratification Is Not Predictive of Outcomes for
Treatment-Naïve Patients with Acute Myeloid Leukemia
Treated with Venetoclax and Azacitidine

Session: Acute Myeloid Leukemias: Commercially Available Therapies,
Excluding Transplantation and Cellular Immunotherapies: Outcomes and
New Treatment Strategies in Genetically Adverse Risk and MRD-positive AML

Sunday, December 11, 2022

4:45 p.m. CT, Oral Presentation

Multi-Omic Single-Cell Sequencing Reveals Genetic and
Immunophenotypic Clonal Selection in Patients With
FLT3-mutated AML Treated With Gilteritinib/Venetoclax

Session: Molecular Pharmacology and Drug Resistance: Myeloid Neoplasms:
Immune Signaling and Antibody-therapeutic Targeting in Myeloid Neoplasms

Monday, December 12, 2022

5:00 p.m. CT

Oral Presentation

Comparison of Patients with Newly Diagnosed (ND)
Acute Myeloid Leukemia (AML) Treated with Venetoclax
and Hypomethylating Agents vs Other Therapies by
TP53 and IDH1/2 Mutation: Results from the AML Real
World EvidenCe (ARC) Initiative

Session: Outcomes Research—Myeloid Malignancies: Poster III

Monday, December 12, 2022

6:00 - 8:00 p.m. CT

Poster Presentation

Real-world Treatment Patterns and Transfusion Burden
Among Newly Diagnosed Older Adults with Acute
Myeloid Leukemia

Session: Acute Myeloid Leukemias: Commercially Available Therapies,
Excluding Transplantation and Cellular Immunotherapies: Poster I

Saturday, December 10, 2022

5:30 - 7:30 p.m. CT

Poster Presentation

Application of a Validated Composite Comorbidity Score
Measuring Both Fitness and Cytogenetic Risk to Assess
Outcomes in 1L AML Patients who Received Venetoclax
Plus Azacitidine in VIALE-A

Session: Acute Myeloid Leukemias: Commercially Available Therapies,
Excluding Transplantation and Cellular Immunotherapies: Poster III

Monday, December 12, 2022

6:00 - 8:00 p.m. CT

Poster Presentation

Clinical Predictors for Relapse Among Patients with
AML Who Responded to Venetoclax-Based Treatment –
a Real-World Prospective Analysis from the Revive
Study Group

Session: Acute Myeloid Leukemias: Commercially Available Therapies,
Excluding Transplantation and Cellular Immunotherapies: Poster III

Monday, December 12, 2022

6:00 - 8:00 p.m. CT

Poster Presentation

Utilization of antifungal prophylaxis and treatment for
newly diagnosed AML patients treated with venetoclax
based regimens in routine clinical practice – a
prospective analysis from the REVIVE study

Session: Acute Myeloid Leukemias: Commercially Available Therapies,
Excluding Transplantation and Cellular

Sunday, December 11, 2022

6:00 - 8:00 p.m. CT

Poster Presentation

Quality of life in patients with chronic lymphocytic
leukemia initiating Venetoclax in routine clinical practice
across Canada: Results from the DEVOTE study

Abstract Publication Only

Real World Effectiveness and Safety of Venetoclax In
Combination With Obinutuzumab In Treatment Naive
CLL Patients – Data From The Observational Study
Verve

Abstract Publication Only

Efficacy and Safety of Treatment Venetoclax
Monotherapy or Combined with Rituximab in Patients
with Relapsed/Refractory Chronic Lymphocytic
Leukemia (CLL) in the Real-World setting in Spain: An
Update of the VENARES study

Session: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster III

Monday, December 12, 2022

6:00 - 8:00 p.m. CT

Poster Presentation

The Economic Impact of Treatment Sequencing in the
Management of Chronic Lymphocytic Leukemia in
Canada using Venetoclax plus Obinutuzumab

Session: Health Services and Quality—Lymphoid Malignancies: Real World
Consequences and Cost of Care

Monday, December 12, 2022

2:45 - 4:15 p.m. CT

Poster Presentation

Long-Term Host Immune Changes Following Treatment
With Venetoclax Plus Rituximab In Relapsed/Refractory
Chronic Lymphocytic Leukemia

Session: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster II

Sunday, December 11, 2022

6:00 - 8:00 p.m. CT

Poster Presentation

Understanding Patient Preferences for Chronic
Lymphocytic Leukemia Treatments

Session: Health Services and Quality—Lymphoid Malignancies: Poster III

Monday, December 12, 2022

6:00 - 8:00 p.m. CT

Poster Presentation

Residual Disease Dynamics Among Patients with
Unmutated IGHV or TP53 Mutations Treated with First-
Line Fixed-Duration Ibrutinib plus Venetoclax (Ibr+Ven)
versus Chlorambucil plus Obinutuzumab (Clb+O): the
GLOW Study

Session: Chronic Lymphocytic Leukemia: Clinical and Epidemiological

Saturday, December 10, 2022

10 a.m. CT

Oral Presentation

Treatment Outcomes After Undetectable MRD With
First-Line Ibrutinib (Ibr) Plus Venetoclax (Ven): Fixed
Duration Treatment (Placebo) Versus Continued Ibr
With Up to 5 Years Median Follow-up in the
CAPTIVATE Study

Session: Outcomes Research—Lymphoid Malignancies: Poster II

Saturday, December 10, 2022

9:45 a.m. CT

Oral Presentation

An Updated Safety and Efficacy Analysis of Venetoclax
Plus Daratumumab and Dexamethasone in an
Expansion Cohort of a Phase 1/2 Study of Patients With
t(11;14) Relapsed/Refractory Multiple Myeloma

Session: Myeloma and Plasma Cell Dyscrasias: Prospective Therapeutic Trials: Poster II

Sunday, December 11, 2022

6:00 - 8:00 p.m. CT

Poster Presentation

Exposure-Response Analysis Supports a Lower Dose of
Venetoclax in t(11;14)-Positive Relapsed/Refractory
Multiple Myeloma Patients When Combined with
Daratumumab and Dexamethasone

Session: Multiple Myeloma and Plasma Cell Dyscrasias: Clinical and Epidemiological: Poster III

Monday, December 12, 2022

6:00 - 8:00 p.m. CT

Poster Presentation

Impact of Venetoclax Exposure on Clinical Efficacy and
Safety in Biomarker-Selected Patients with Relapsed or
Refractory Multiple Myeloma: Implication for Dose
Selection

Session: Multiple Myeloma and Plasma Cell Dyscrasias: Clinical and Epidemiological: Poster I

Saturday, December 10, 2022

5:30 - 7:30 p.m. CT

Poster Presentation

Genomic Landscape of t(11;14) in Multiple Myeloma

Session: Multiple Myeloma and Plasma Cell Dyscrasias: Clinical and Epidemiological: Poster III

Monday, December 12, 2022

6:00 - 8:00 p.m. CT

Poster Presentation

Treatment Patterns and Outcomes in Patients With
Relapsed/Refractory Multiple Myeloma Receiving ≥3
Lines of Therapy: A Real-World Evaluation in the
United States

Session: Outcomes Research—Myeloid Malignancies: Poster I

Saturday, December 10, 2022

5:30 - 7:30 p.m. CT

Poster Presentation

Real-World Treatment Patterns and Outcomes of
Daratumumab Retreatment in Multiple Myeloma in the
United States

Session: Outcomes Research—Myeloid Malignancies: Poster I

Saturday, December 10, 2022

5:30 - 7:30 p.m. CT

Poster Presentation

A Sensitive Machine Learning-Based Approach to
Assess Multiple Myeloma t(11;14) Genetic Subtype
From Histopathology Images

Session: Emerging Tools, Techniques and Artificial Intelligence in Hematology: Poster II

Sunday, December 11, 2022

6:00 - 8:00 p.m. CT

Poster Presentation

Clinical Genomic Analyses Demonstrate t(11;14)
Multiple Myeloma Retains B-Cell Biology and Distinct
Mitochondrial Metabolism That Convey Increased
Sensitivity to BCL-2 Inhibition by Venetoclax

Session: Multiple Myeloma and Plasma Cell Dyscrasias: Basic and Translational: Poster I

Saturday, December 10, 2022

5:30 - 7:30 p.m. CT

Poster Presentation

Treatment patterns and overall survival (OS) among
patients with myelodysplastic syndromes (MDS) treated
in the US community oncology setting: a real-world
retrospective observational study

Session: Myelodysplastic Syndromes – Clinical and Epidemiological: Poster II

Sunday, December 11, 2022

6:00 - 8:00 p.m. CT

Poster Presentation

Burden of Illness in Patients with Higher-Risk
Myelodysplastic Syndromes by Baseline Transfusion
Status 

Session: Outcomes Research—Myeloid Malignancies: Poster III

Monday, December 12, 2022

6:00 - 8:00 p.m. CT

Poster Presentation

ITCC-101/APAL2020D: A Randomized Phase 3 Trial of
Fludarabine /Cytarabine/Gemtuzumab Ozogamycin with
or without Venetoclax in Children with Relapsed Acute
Myeloid leukemia

Session: Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and
Cellular Immunotherapies: Poster I

Saturday, December 10, 2022

5:30 - 7:30 p.m. CT

Poster Presentation

Navitoclax

The Combination of Navitoclax and Ruxolitinib in JAK
Inhibitor-Naïve Patients With Myelofibrosis Mediates
Responses Suggestive of Disease Modification

Session: Myeloproliferative Syndromes: Clinical and Epidemiological: Latest Data for
Combination and Emerging Targeted Therapies in Myelofibrosis

Saturday, December 10, 2022

2:00 - 3:30 PM CT; Presentation Time 2:30 PM CT

Oral Presentation

Epcoritamab

Evaluation of Epcoritamab and Rituximab Combination
in Preclinical Models of B-cell non-Hodgkin's Lymphoma
(NHL)

Session: Lymphomas: Translational–Non-Genetic: Poster III

Monday, December 12, 2022

6:00 - 8:00 p.m. CT

Poster Presentation

Phase 1b Trial of Subcutaneous Epcoritamab in
Pediatric Patients With Relapsed or Refractory (R/R)
Aggressive Mature B-Cell Neoplasms (EPCORE Peds-1)

Session: Aggressive Lymphomas: Clinical and Epidemiological: Poster I

Saturday, December 10, 2022

5:30 - 7:30 p.m. CT

Poster Presentation

Phase 2 Trial to Evaluate Safety of Subcutaneous
Epcoritamab Monotherapy in the Outpatient Setting
Among Patients with Relapsed or Refractory Diffuse
Grade 1–3a Large B-cell and Follicular Lymphoma
(EPCORE NHL-6)

Session: Aggressive Lymphomas: Clinical and Epidemiological: Poster III

Monday, December 12, 2022

6:00 - 8:00 p.m. CT

Poster Presentation

Phase 3 Trial of Subcutaneous Epcoritamab in
Combination With Rituximab and Lenalidomide (R2) vs
R2 Among Patients With Relapsed or Refractory
Follicular Lymphoma (EPCORE FL-1)

Session: Mantle Cell, Follicular, and Other Indolent B Cell Lymphomas: Clinical and
Epidemiological: Poster III

Monday, December 12, 2022

6:00 - 8:00 p.m. CT

Poster Presentation

Health Care Resource Utilization and Costs of CAR T
Therapy in Patients With Large B-Cell Lymphoma: a
Retrospective US Claims Database Analysis

Session: Health Services and Quality—Lymphoid Malignancies: Poster I

Saturday, December 10, 2022

5:30 - 7:30 p.m. CT

Poster Presentation

Follicular Lymphoma Treatment Patterns and Outcomes
Over Time: A Real-World Analysis in the United States

Session: Outcomes Research—Lymphoid Malignancies: Poster I

Saturday, December 10, 2022

5:30 - 7:30 p.m. CT

Poster Presentation

Indirect Comparisons of the Efficacy of Subcutaneous
Epcoritamab vs Chemoimmunotherapy in Patients with
Relapsed or Refractory Large B-cell Lymphoma

Session: Outcomes Research—Lymphoid Malignancies: Poster III

Monday, December 12, 2022

6:00 - 8:00 p.m. CT

Poster Presentation

Subcutaneous Epcoritamab in Novel Combinations with
Antineoplastic Agents Among Patients with B-cell Non-
Hodgkin Lymphoma in a Phase 1b/2, Multicenter, Open-
Label Study: Assessing Safety, Tolerability, and
Preliminary Efficacy (EPCORE NHL-5)

Abstract Publication Only

Subcutaneous Epcoritamab + R-Dhax/C in Patients with
Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Eligible for Autologous Stem Cell Transplant: Updated
Phase 1/2 Results

Session: Aggressive Lymphomas: Prospective
Therapeutic Trials: Immune Based and Targeted
Therapies in Relapsed/Refractory Large B-Cell
Lymphoma

Sunday, December 11, 2022

Session Time: 9:30 - 11:00 a.m. CT;

Presentation Time: 10:30 a.m. CT

Oral Presentation

Subcutaneous Epcoritamab with Rituximab +
Lenalidomide in Patients with Relapsed or Refractory
Follicular Lymphoma: Phase 1/2 Trial Update

Session: Mantle Cell, Follicular, and Other Indolent B Cell
Lymphomas: Clinical and Epidemiological IV

Sunday, December 11, 2022

Session Time: 4:30 - 6:00 p.m. CT;

Presentation Time: 5:00 p.m. CT

Oral Presentation

Subcutaneous Epcoritamab in Combination with
Rituximab + Lenalidomide (R2) for First-Line Treatment
of Follicular Lymphoma: Initial Results from Phase 1/2
Trial

Session: Mantle Cell, Follicular, and Other Indolent B Cell
Lymphomas: Clinical and Epidemiological IV

Sunday, December 11, 2022

Session Time: 4:30 - 6:00 p.m. CT;

Presentation Time: 5:30 p.m. CT

Oral Presentation

Deep Peripheral T Cell Immune-Profiling in
Relapsed/Refractory Non-Hodgkin Lymphoma:
Evaluation of Baseline Samples from the Epcoritamab
Epcore NHL-1 Trial

Session: Lymphomas: Translational–Non-Genetic: Poster II

Sunday, December 11, 2022

6:00 - 8:00 p.m. CT

Poster Presentation

Transcriptomic comparison of non-Hodgkin lymphomas
in relapsed/refractory versus newly diagnosed patients
using single FFPE slides

Session: Lymphomas: Translational—Molecular and Genetic: Poster II

Sunday, December 11, 2022

6:00 - 8:00 p.m. CT

Poster Presentation

Real-World Outcomes in Patients with Relapsed or
Refractory Diffuse Large B-Cell Lymphoma Treated with
Standard of Care: A Cota Database Analysis

Session: Aggressive Lymphomas: Clinical and Epidemiological: Poster II

Sunday, December 11, 2022

6:00 - 8:00 p.m. CT

Poster Presentation

Improvements in Lymphoma Symptoms and Health-
Related Quality of Life in Patients with Relapsed or
Refractory Large B-Cell Lymphoma Treated with
Subcutaneous Epcoritamab (EPCORE NHL-1)

Session: Outcomes Research—Lymphoid Malignancies: Poster II

Sunday, December 11, 2022

6:00 - 8:00 p.m. CT

Poster Presentation

Epcoritamab Monotherapy Provides Deep and Durable
Responses Including Minimal Residual Disease (MRD)
Negativity: Novel Subgroup Analyses in Patients with
Relapsed/Refractory (R/R) Large B-Cell Lymphoma (LBCL)

Session: Aggressive Lymphomas: Prospective Therapeutic Trials: Poster III

Monday, December 12, 2022

6:00 - 8:00 p.m. CT

Poster Presentation

Subcutaneous Epcoritamab in Patients with Richter's
Syndrome: Early Results from Phase 1b/2 Trial
(EPCORE CLL-1)

Session: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Targeted Triplet

Saturday, December 10, 2022

Session Time: 4:00 - 5:30 p.m. CT;

Presentation Time: 5:15 p.m. CT

Oral Presentation

ABBV-319

A First-In-Human Phase I Study of ABBV-319, an
Antibody-Drug Conjugate Composed of a CD19
Antibody Linked to a Glucocorticoid Receptor
Modulator, in Patients with Relapsed or Refractory
B-cell Malignancies

Session: Aggressive Lymphomas: Prospective Therapeutic Trials: Poster I

Saturday, December 10, 2022

5:30 - 7:30 p.m. CT

Poster Presentation

ABBV-383

Dose Escalation and Expansion of ABBV-383 in
Combination with Anti-cancer Regimens in Relapsed or
Refractory Multiple Myeloma

Session: Myeloma and Plasma Cell Dyscrasias: Prospective Therapeutic Trials: Poster II

Sunday, December 11, 2022

6:00 - 8:00 p.m. CT

Poster Presentation

A Phase 1 First-In-Human study of ABBV-383, a BCMA
x CD3 Bispecific T-cell Redirecting Antibody, as
Monotherapy in Patients with Relapsed/Refractory Multiple Myeloma

Session: Myeloma and Plasma Cell Dyscrasias: Prospective Therapeutic Trials: Poster I

Saturday, December 10, 2022

5:30 - 7:30 p.m. CT

Poster Presentation

 

The ASH 2022 Annual Meeting abstracts are available here.

Epcoritamab is an investigational anti-CD20 x CD3 bispecific antibody being co-developed by AbbVie and Genmab as part of the companies' broad oncology collaboration. Epcoritamab is not approved by any health authority worldwide at this time. Its safety and efficacy are under evaluation as part of ongoing registrational studies.

Navitoclax is an investigational, oral BCL-XL/BCL-2 inhibitor. Navitoclax is not approved by any health authority worldwide at this time. Its safety and efficacy are under evaluation as part of ongoing registrational studies.

Use of venetoclax in Multiple Myeloma (MM) is not approved by any health authority worldwide at this time. Its safety and efficacy are under evaluation as part of ongoing registrational studies.

A combination of ibrutinib and venetoclax is not approved by any health authority worldwide at this time. Its safety and efficacy are under evaluation as part of ongoing registrational studies.

ABBV-319 and ABBV-383 are not approved by any health authority worldwide at this time. Their safety and efficacy are under evaluation as part of ongoing clinical studies.

About IMBRUVICA®
IMBRUVICA® (ibrutinib) is a once-daily oral medication that is jointly developed and commercialized by Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie company. IMBRUVICA® blocks the Bruton's tyrosine kinase (BTK) protein, which is needed by normal and abnormal B cells, including specific cancer cells, to multiply and spread. By blocking BTK, IMBRUVICA® may help move abnormal B cells out of their nourishing environments and inhibits their proliferation.7,8,9

IMBRUVICA® is approved in more than 100 countries and has been used to treat more than 250,000 patients worldwide. There are more than 50 company-sponsored clinical trials, including 18 Phase 3 studies, over 11 years evaluating the efficacy and safety of IMBRUVICA®.

IMBRUVICA® was first approved by the U.S. Food and Drug Administration (FDA) in November 2013, and today is indicated for adult patients in six disease areas, including five hematologic cancers. These include indications to treat adults with CLL/SLL with or without 17p deletion (del17p), adults with Waldenström's macroglobulinemia (WM), adults with previously treated mantle cell lymphoma (MCL)*, adult patients with previously treated marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy*, as well as adult and pediatric patients one year and older with previously treated chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy.6 

*Accelerated approval was granted for MCL and MZL based on overall response rate. Continued approval for MCL and MZL may be contingent upon verification and description of clinical benefit in confirmatory trials.

For more information, visit www.IMBRUVICA.com.

IMPORTANT SAFETY INFORMATION

Before taking IMBRUVICA®, tell your healthcare provider about all of your medical conditions, including if you:

  • have had recent surgery or plan to have surgery. Your healthcare provider may stop IMBRUVICA® for any planned medical, surgical, or dental procedure.
  • have bleeding problems
  • have or had heart rhythm problems, smoke, or have a medical condition that increases your risk of heart disease, such as high blood pressure, high cholesterol, or diabetes
  • have an infection
  • have liver problems
  • are pregnant or plan to become pregnant. IMBRUVICA® can harm your unborn baby. If you are able to become pregnant, your healthcare provider will do a pregnancy test before starting treatment with IMBRUVICA®. Tell your healthcare provider if you are pregnant or think you may be pregnant during treatment with IMBRUVICA®.
    • Females who are able to become pregnant should use effective birth control (contraception) during treatment with IMBRUVICA® and for 1 month after the last dose.
    • Males with female partners who are able to become pregnant should use effective birth control, such as condoms, during treatment with IMBRUVICA® and for 1 month after the last dose.
  • are breastfeeding or plan to breastfeed. Do not breastfeed during treatment with IMBRUVICA® and for 1 week after the last dose.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking IMBRUVICA® with certain other medicines may affect how IMBRUVICA® works and can cause side effects.

How should I take IMBRUVICA®?

  • Take IMBRUVICA® exactly as your healthcare provider tells you to take it.
  • Take IMBRUVICA® 1 time a day at about the same time each day.

IMBRUVICA® comes as capsules, tablets, and oral suspension.

  • If your healthcare provider prescribes IMBRUVICA® capsules or tablets:
    • Swallow IMBRUVICA® capsules or tablets whole with a glass of water.
    • Do not open, break, or chew IMBRUVICA® capsules.
    • Do not cut, crush, or chew IMBRUVICA® tablets.
  • If your healthcare provider prescribes IMBRUVICA® oral suspension:
    • See the detailed Instructions for Use that comes with IMBRUVICA® oral suspension for information about the correct way to give a dose to your child. If you have questions about how to give IMBRUVICA® oral suspension, talk to your healthcare provider.
    • Do not use if the carton seal is broken or missing.
  • If you miss a dose of IMBRUVICA® take it as soon as you remember on the same day. Take your next dose of IMBRUVICA® at your regular time on the next day. Do not take extra doses of IMBRUVICA® to make up for a missed dose.
  • If you take too much IMBRUVICA® call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while taking IMBRUVICA®?

  • You should not drink grapefruit juice, eat grapefruit, or eat Seville oranges (often used in marmalades) during treatment with IMBRUVICA®. These products may increase the amount of IMBRUVICA® in your blood.

What are the possible side effects of IMBRUVICA®?
IMBRUVICA
® may cause serious side effects, including:

  • Bleeding problems (hemorrhage) are common during treatment with IMBRUVICA®, and can also be serious and may lead to death. Your risk of bleeding may increase if you are also taking a blood thinner medicine. Tell your healthcare provider if you have any signs of bleeding, including: blood in your stools or black stools (looks like tar), pink or brown urine, unexpected bleeding, or bleeding that is severe or that you cannot control, vomit blood or vomit looks like coffee grounds, cough up blood or blood clots, increased bruising, dizziness, weakness, confusion, change in your speech, or a headache that lasts a long time or severe headache.
  • Infections can happen during treatment with IMBRUVICA®. These infections can be serious and may lead to death. Tell your healthcare provider right away if you have fever, chills, weakness, confusion, or other signs or symptoms of an infection during treatment with IMBRUVICA®.
  • Heart problems. Serious heart rhythm problems (ventricular arrhythmias, atrial fibrillation and atrial flutter), heart failure and death have happened in people treated with IMBRUVICA®, especially in people who have an infection, an increased risk for heart disease, or have had heart rhythm problems in the past. Your heart function will be checked before and during treatment with IMBRUVICA®. Tell your healthcare provider if you get any symptoms of heart problems, such as feeling as if your heart is beating fast and irregular, lightheadedness, dizziness, shortness of breath, swelling of the feet, ankles or legs, chest discomfort, or you faint. If you develop any of these symptoms, your healthcare provider may do tests to check your heart and may change your IMBRUVICA® dose.
  • High blood pressure (hypertension). New or worsening high blood pressure has happened in people treated with IMBRUVICA®. Your healthcare provider may start you on blood pressure medicine or change current medicines to treat your blood pressure.
  • Decrease in blood cell counts. Decreased blood counts (white blood cells, platelets, and red blood cells) are common with IMBRUVICA®, but can also be severe. Your healthcare provider should do monthly blood tests to check your blood counts.
  • Second primary cancers. New cancers have happened during treatment with IMBRUVICA®, including cancers of the skin or other organs.
  • Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure, and sometimes death. Your healthcare provider may do blood tests to check you for TLS.

The most common side effects of IMBRUVICA® in adults with B-cell malignancies (MCL, CLL/SLL, WM and MZL) include:

  • diarrhea
  • tiredness
  • muscle and bone pain
  • rash
  • bruising

The most common side effects of IMBRUVICA® in adults or children 1 year of age and older with cGVHD include:

  • tiredness
  • low red blood cell count (anemia)
  • bruising
  • diarrhea
  • low platelet count
  • muscle and joint pain
  • fever
  • muscle spasms
  • mouth sores (stomatitis)
  • bleeding
  • nausea
  • stomach pain
  • pneumonia
  • headache

Diarrhea is a common side effect in people who take IMBRUVICA®. Drink plenty of fluids during treatment with IMBRUVICA® to help reduce your risk of losing too much fluid (dehydration) due to diarrhea. Tell your healthcare provider if you have diarrhea that does not go away.

These are not all the possible side effects of IMBRUVICA®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of IMBRUVICA®
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use IMBRUVICA® for a condition for which it was not prescribed. Do not give IMBRUVICA® to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about IMBRUVICA® that is written for health professionals.

Please see the full Important Product Information.

About VENCLYXTA® (venetoclax) 
VENCLYXTA® (venetoclax) is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis. VENCLYXTA targets the BCL-2 protein and works to help restore the process of apoptosis.

VENCLYXTA is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. Together, the companies are committed to BCL-2 research and to studying venetoclax in clinical trials across several blood and other cancers. Venetoclax is approved in more than 80 countries, including the U.S.

Approved Uses of VENCLEXTA

VENCLEXTA is a prescription medicine used:

  • to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
  • in combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with
    newly diagnosed acute myeloid leukemia (AML) who:
    • are 75 years of age or older, or
    • have other medical conditions that prevent the use of standard chemotherapy.

It is not known if VENCLEXTA is safe and effective in children.

Important Safety Information

What is the most important information I should know about VENCLEXTA?

VENCLEXTA can cause serious side effects, including:

Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, and may lead to death. Your healthcare provider will do tests to check your risk of getting TLS before you start taking VENCLEXTA. You will receive other medicines before starting and during treatment with VENCLEXTA to help reduce your risk of TLS.

You may also need to receive intravenous (IV) fluids into your vein. Your healthcare provider will do blood tests to check for TLS when you first start treatment and during treatment with VENCLEXTA.

It is important to keep your appointments for blood tests. Tell your healthcare provider right away if you have any symptoms of TLS during treatment with VENCLEXTA, including fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, or muscle or joint pain.

Drink plenty of water during treatment with VENCLEXTA to help reduce your risk of getting TLS. 

Drink 6 to 8 glasses (about 56 ounces total) of water each day, starting 2 days before your first dose, on the day of your first dose of VENCLEXTA, and each time your dose is increased.

Your healthcare provider may delay, decrease your dose, or stop treatment with VENCLEXTA if you have side effects. When restarting VENCLEXTA after stopping for 1 week or longer, your healthcare provider may again check for your risk of TLS and change your dose.

Who should not take VENCLEXTA?

Certain medicines must not be taken when you first start taking VENCLEXTA and while your dose is being slowly increased because of the risk of increased TLS.

  • Tell your healthcare provider about all the medicines you take, including prescription and over-the- counter medicines, vitamins, and herbal supplements. VENCLEXTA and other medicines may affect each other causing serious side effects.
  • Do not start new medicines during treatment with VENCLEXTA without first talking with your healthcare provider.

Before taking VENCLEXTA, tell your healthcare provider about all of your medical conditions, including if you:

  • have kidney or liver problems.
  • have problems with your body salts or electrolytes, such as potassium, phosphorus, or calcium.
  • have a history of high uric acid levels in your blood or gout.
  • are scheduled to receive a vaccine. You should not receive a "live vaccine" before, during, or after treatment with VENCLEXTA, until your healthcare provider tells you it is okay. If you are not sure about the type of immunization or vaccine, ask your healthcare provider. These vaccines may not be safe or may not work as well during treatment with VENCLEXTA.
  • are pregnant or plan to become pregnant. VENCLEXTA may harm your unborn baby. If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with VENCLEXTA, and you should use effective birth control during treatment and for 30 days after the last dose of VENCLEXTA. If you become pregnant or think you are pregnant, tell your healthcare provider right away.
  • are breastfeeding or plan to breastfeed. It is not known if VENCLEXTA passes into your breast milk.
    Do not breastfeed during treatment with VENCLEXTA and for 1 week after the last dose.

What should I avoid while taking VENCLEXTA?

You should not drink grapefruit juice or eat grapefruit, Seville oranges (often used in marmalades), or starfruit while you are taking VENCLEXTA. These products may increase the amount of VENCLEXTA in your blood.

What are the possible side effects of VENCLEXTA?

VENCLEXTA can cause serious side effects, including:

  • Low white blood cell counts (neutropenia). Low white blood cell counts are common with VENCLEXTA, but can also be severe. Your healthcare provider will do blood tests to check your blood counts during treatment with VENCLEXTA and may pause dosing.
  • Infections. Death and serious infections such as pneumonia and blood infection (sepsis) have happened during treatment with VENCLEXTA. Your healthcare provider will closely monitor and treat you right away if you have a fever or any signs of infection during treatment with VENCLEXTA.

Tell your healthcare provider right away if you have a fever or any signs of an infection during treatment with VENCLEXTA.

The most common side effects of VENCLEXTA when used in combination with obinutuzumab or rituximab or alone in people with CLL or SLL include low white blood cell counts; low platelet counts; low red blood cell counts; diarrhea; nausea; upper respiratory tract infection; cough; muscle and joint pain; tiredness; and swelling of your arms, legs, hands, and feet.

The most common side effects of VENCLEXTA in combination with azacitidine or decitabine or low-dose cytarabine in people with AML include nausea; diarrhea; low platelet count; constipation; low white blood cell count; fever with low white blood cell count; tiredness; vomiting; swelling of arms, legs, hands, or feet; fever; infection in lungs; shortness of breath; bleeding; low red blood cell count; rash; stomach (abdominal) pain; infection in your blood; muscle and joint pain; dizziness; cough; sore throat; and low blood pressure.

VENCLEXTA may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of VENCLEXTA. Call your doctor for medical advice about side effects.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

If you cannot afford your medication, contact genentech-access.com/patient/brands/venclexta for assistance.

About Epcoritamab
Epcoritamab is an investigational IgG1-bispecific antibody created using Genmab's proprietary DuoBody technology. Genmab's DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response towards target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B-cells and induces T cell mediated killing of CD20+ cells.5 CD20 is expressed on B-cells and a clinically validated therapeutic target in many B-cell malignancies, including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma and chronic lymphocytic leukemia.6,7 Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' broad oncology collaboration.

About Navitoclax
Navitoclax is an investigational, oral BCL-XL/BCL-2 inhibitor. The BCL-2 family of proteins are known regulators of the apoptosis pathway.3 Navitoclax is not approved by the U.S. Food and Drug Administration (FDA) or any Health Authority worldwide at this time. Its safety and efficacy are under evaluation as part of ongoing Phase 2 and registrational Phase 3 studies.

AbbVie has an extensive late-stage clinical trial program for investigational navitoclax that is currently enrolling. For more information about enrolling in a clinical trial, please visit us here

About AbbVie in Oncology
At AbbVie, we are committed to transforming standards of care for multiple blood cancers while advancing a dynamic pipeline of investigational therapies across a range of cancer types. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potentially breakthrough medicines. We are evaluating more than 20 investigational medicines in over 300 clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit http://www.abbvie.com/oncology and our Blood Cancer Press kit page.

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2021 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

Cision View original content:https://www.prnewswire.com/news-releases/abbvie-highlights-blood-cancer-data-from-its-growing-oncology-pipeline-at-the-64th-ash-annual-meeting-301685643.html

SOURCE AbbVie

 
 
Company Codes: NYSE:ABBV
 

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