- 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.
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SOURCE AbbVie