The Influence of Inaction – New Publication Reveals Not All of Canada is on Observe to Meet International Hepatitis C Elimination Objective

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“Our newest analysis is pushed by our dedication to assist enhance the well being and lives of individuals residing with blood cancers,” mentioned Mohamed Zaki , M.D., Ph.D., vp and world head of oncology growth, AbbVie. “The info we’re presenting on the ASH annual congress represents progress in our increasing hematology oncology portfolio and the potential to assist tackle extra blood most cancers affected person wants sooner or later.”

At ASH, AbbVie will current the most recent knowledge for investigational and accredited blood most cancers therapies together with:

  • investigational medication epcoritamab (an anti-CD20 x CD3 bispecific antibody) in partnership with Genmab for Non-Hodgkins Lymphomas together with Giant B-Cell Lymphoma (LBCL) and Follicular Lymphoma (FL);
  • investigational navitoclax together with ruxolitinib in JAK inhibitor-naïve sufferers with Myelofibrosis (MF);
  • new knowledge from the Part 2 CAPTIVATE and Part 3 GLOW research evaluating residual illness and disease-free survival outcomes in Continual Lymphocytic Leukemia (CLL)/Small Lymphocytic Leukemia (SLL) sufferers who acquired the investigational ibrutinib (IMBRUVICA®) + venetoclax (VENCLEXTA®) mixture;
  • a number of abstracts evaluating venetoclax in accredited CLL and Acute Myeloid Leukemia (AML) indications and an investigational A number of Myeloma (MM) indication.

Knowledge presentation particulars embody:

ASH 2022 Abstracts

Summary

Presentation Particulars

All Occasions in CT

Ibrutinib

Remedy Outcomes After Undetectable MRD With
First-Line Ibrutinib (Ibr) Plus Venetoclax (Ven): Mounted
Period Remedy (Placebo) Versus Continued Ibr
With As much as 5 Years Median Comply with-up within the
CAPTIVATE Research

Session: Continual Lymphocytic Leukemia: Medical and Epidemiological: Focused Doublet Mixtures

Saturday, December 10, 2022

9:45 a.m. CT

Oral Presentation

Residual Illness Dynamics Amongst Sufferers with
Unmutated IGHV or TP53 Mutations Handled with First-
Line Mounted-Period Ibrutinib plus Venetoclax (Ibr+Ven)
versus Chlorambucil plus Obinutuzumab (Clb+O): the
GLOW Research

Session: Continual Lymphocytic Leukemia: Medical and Epidemiological: Focused Doublet Mixtures

Saturday, December 10, 2022

10:00 a.m. CT

Oral Presentation

Actual-World Comparability of Time to Subsequent Remedy
Between Sufferers Initiated on Single-Agent Ibrutinib or
Acalabrutinib in First Line

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

11:30 a.m. CT

Oral Presentation

Initiating Firstline (1L) Ibrutinib (Ibr) in Continual
Lymphocytic Leukemia (CLL) Sufferers (pts) Improves
General Survival (OS) Outcomes to Charges Approximating
an Age-Matched Inhabitants of ≥ 65 Years

Session: Continual Lymphocytic Leukemia: Medical and Epidemiological: Poster I

Saturday, December 10, 2022

5:30 – 7:30 p.m. CT

Poster Presentation

Actual-World Outcomes With First-Line Ibrutinib (Ibr)
Versus Chemoimmunotherapy (CIT) in Sufferers With
Continual Lymphocytic Leukemia (CLL)/Small
Lymphocytic Lymphoma (SLL): Closing Evaluation Outcomes
From the informCLL Registry

Session: Continual Lymphocytic Leukemia: Medical 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 Amongst Sufferers with Continual
Lymphocytic Leukemia/Small Lymphocytic Lymphoma
and Atrial Fibrillation

Session: Outcomes Analysis—Lymphoid Malignancies: Poster III

Monday, December 12, 2022

6:00 – 8:00 p.m. CT

Poster Presentation

Actual World Remedy Patterns in Sufferers with Continual
Lymphocytic Leukemia and Small Lymphocytic
Lymphoma Switching From First Line Ibrutinib to
Acalabrutinib Monotherapy

Session: Outcomes Analysis—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 Upkeep (I+BR) Versus Rituximab,
Cyclophosphamide, Doxorubicin, Vincristine,
Prednisone Routine (R-CHOP) and Rituximab,
Cyclophosphamide, Doxorubicin, Bortezomib,
Prednisone Routine (VR-CAP) in First-Line Mantle Cell
Lymphoma Sufferers: An Adjusted Remedy
Comparability Utilizing Inverse Chance Weighting

Session: Mantle Cell, Follicular, and Different Indolent B Cell Lymphomas:
Medical and Epidemiological: Poster I

Presentation

Saturday, December 10, 2022

5:30 – 7:30 p.m. CT

Poster Presentation

Effectiveness and Security of Ibrutinib in Sufferers with
Mantle Cell Lymphoma (MCL) in Belgian Routine
Medical Apply: 3-12 months Comply with-up

Session: Mantle Cell, Follicular, and Different Indolent B Cell Lymphomas:
Medical and Epidemiological: Poster I

Presentation

Saturday, December 10, 2022

5:30 – 7:30 p.m. CT

Poster Presentation

Exterior Validation of the FLIPI Threat Rating Measured at
Preliminary Prognosis and POD24 amongst Beforehand Handled
People with Progressed Follicular Lymphoma in
Alberta, Canada

Session: Outcomes Analysis—Lymphoid Malignancies: Poster II Presentation

Sunday, December 11, 2022

6:00 – 8:00 p.m. CT

Poster Presentation

FIRE: General and Subgroup Outcomes from the Third
Interim Evaluation of FIRE, a Actual-World Research of Ibrutinib
Remedy for CLL/SLL in France

Session: Continual Lymphocytic Leukemia: Medical and Epidemiological: Poster III Presentation

Monday, December 12, 2022

6:00 – 8:00 p.m. CT

Poster Presentation

Use of Ibrutinib in Actual Life Settings in France: outcomes
from a retrospective Observational Research utilizing the
SNDS database (OSIRIS)

Session: 642. Continual Lymphocytic Leukemia: Medical and Epidemiological: Poster III

Monday, December 12, 2022

6:00 PM-8:00 PM
Poster Presentation

Actual-World Consequence of Remedy with Single-Agent
Ibrutinib in Sufferers with Continual Lymphocytic Leukemia:
Outcomes from the Italian Research Proof

Session: Continual Lymphocytic Leukemia: Medical and Epidemiological: Poster I Presentation

Saturday, December 10, 2022

5:30 – 7:30 p.m. CT

Poster Presentation

Actual-world Outcomes with Ibrutinib in Sufferers with
Continual Lymphocytic Leukemia: Influence of Affected person
Typology on Adherence and Retention Charges inside the
German REALITY Research

Summary Publication Solely

Venetoclax

Lengthy-Time period Comply with-Up of the Part 3 VIALE-A Medical
Trial of Venetoclax Plus Azacitidine for Sufferers with
Untreated Acute Myeloid Leukemia Ineligible for
Intensive Chemotherapy

Session: Acute Myeloid Leukemias: Commercially Out there Therapies,
Excluding Transplantation and Mobile Immunotherapies: New Approaches
to Mixture Chemotherapy and Venetoclax Plus Hypomethylating Agent Remedy in AML

Saturday, December 10, 2022

2:30 p.m. CT

Oral Presentation

ELN Threat Stratification Is Not Predictive of Outcomes for
Remedy-Naïve Sufferers with Acute Myeloid Leukemia
Handled with Venetoclax and Azacitidine

Session: Acute Myeloid Leukemias: Commercially Out there Therapies,
Excluding Transplantation and Mobile Immunotherapies: Outcomes and
New Remedy Methods in Genetically Hostile Threat 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 Choice in Sufferers With
FLT3-mutated AML Handled With Gilteritinib/Venetoclax

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

Monday, December 12, 2022

5:00 p.m. CT

Oral Presentation

Comparability of Sufferers with Newly Identified (ND)
Acute Myeloid Leukemia (AML) Handled with Venetoclax
and Hypomethylating Brokers vs Different Therapies by
TP53 and IDH1/2 Mutation: Outcomes from the AML Actual
World EvidenCe (ARC) Initiative

Session: Outcomes Analysis—Myeloid Malignancies: Poster III

Monday, December 12, 2022

6:00 – 8:00 p.m. CT

Poster Presentation

Actual-world Remedy Patterns and Transfusion Burden
Amongst Newly Identified Older Adults with Acute
Myeloid Leukemia

Session: Acute Myeloid Leukemias: Commercially Out there Therapies,
Excluding Transplantation and Mobile Immunotherapies: Poster I

Saturday, December 10, 2022

5:30 – 7:30 p.m. CT

Poster Presentation

Utility of a Validated Composite Comorbidity Rating
Measuring Each Health and Cytogenetic Threat to Assess
Outcomes in 1L AML Sufferers who Acquired Venetoclax
Plus Azacitidine in VIALE-A

Session: Acute Myeloid Leukemias: Commercially Out there Therapies,
Excluding Transplantation and Mobile Immunotherapies: Poster III

Monday, December 12, 2022

6:00 – 8:00 p.m. CT

Poster Presentation

Medical Predictors for Relapse Amongst Sufferers with
AML Who Responded to Venetoclax-Primarily based Remedy –
a Actual-World Potential Evaluation from the Revive
Research Group

Session: Acute Myeloid Leukemias: Commercially Out there Therapies,
Excluding Transplantation and Mobile Immunotherapies: Poster III

Monday, December 12, 2022

6:00 – 8:00 p.m. CT

Poster Presentation

Utilization of antifungal prophylaxis and remedy for
newly recognized AML sufferers handled with venetoclax
based mostly regimens in routine scientific apply – a
potential evaluation from the REVIVE research

Session: Acute Myeloid Leukemias: Commercially Out there Therapies,
Excluding Transplantation and Mobile

Sunday, December 11, 2022

6:00 – 8:00 p.m. CT

Poster Presentation

High quality of life in sufferers with power lymphocytic
leukemia initiating Venetoclax in routine scientific apply
throughout Canada: Outcomes from the DEVOTE research

Summary Publication Solely

Actual World Effectiveness and Security of Venetoclax In
Mixture With Obinutuzumab In Remedy Naive
CLL Sufferers – Knowledge From The Observational Research
Verve

Summary Publication Solely

Efficacy and Security of Remedy Venetoclax
Monotherapy or Mixed with Rituximab in Sufferers
with Relapsed/Refractory Continual Lymphocytic
Leukemia (CLL) within the Actual-World setting in Spain: An
Replace of the VENARES research

Session: Continual Lymphocytic Leukemia: Medical and Epidemiological: Poster III

Monday, December 12, 2022

6:00 – 8:00 p.m. CT

Poster Presentation

The Financial Influence of Remedy Sequencing within the
Administration of Continual Lymphocytic Leukemia in
Canada utilizing Venetoclax plus Obinutuzumab

Session: Well being Providers and High quality—Lymphoid Malignancies: Actual World
Penalties and Price of Care

Monday, December 12, 2022

2:45 – 4:15 p.m. CT

Poster Presentation

Lengthy-Time period Host Immune Modifications Following Remedy
With Venetoclax Plus Rituximab In Relapsed/Refractory
Continual Lymphocytic Leukemia

Session: Continual Lymphocytic Leukemia: Medical and Epidemiological: Poster II

Sunday, December 11, 2022

6:00 – 8:00 p.m. CT

Poster Presentation

Understanding Affected person Preferences for Continual
Lymphocytic Leukemia Therapies

Session: Well being Providers and High quality—Lymphoid Malignancies: Poster III

Monday, December 12, 2022

6:00 – 8:00 p.m. CT

Poster Presentation

Residual Illness Dynamics Amongst Sufferers with
Unmutated IGHV or TP53 Mutations Handled with First-
Line Mounted-Period Ibrutinib plus Venetoclax (Ibr+Ven)
versus Chlorambucil plus Obinutuzumab (Clb+O): the
GLOW Research

Session: Continual Lymphocytic Leukemia: Medical and Epidemiological

Saturday, December 10, 2022

10 a.m. CT

Oral Presentation

Remedy Outcomes After Undetectable MRD With
First-Line Ibrutinib (Ibr) Plus Venetoclax (Ven): Mounted
Period Remedy (Placebo) Versus Continued Ibr
With As much as 5 Years Median Comply with-up within the
CAPTIVATE Research

Session: Outcomes Analysis—Lymphoid Malignancies: Poster II

Saturday, December 10, 2022

9:45 a.m. CT

Oral Presentation

An Up to date Security and Efficacy Evaluation of Venetoclax
Plus Daratumumab and Dexamethasone in an
Growth Cohort of a Part 1/2 Research of Sufferers With
t(11;14) Relapsed/Refractory A number of Myeloma

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

Sunday, December 11, 2022

6:00 – 8:00 p.m. CT

Poster Presentation

Publicity-Response Evaluation Helps a Decrease Dose of
Venetoclax in t(11;14)-Optimistic Relapsed/Refractory
A number of Myeloma Sufferers When Mixed with
Daratumumab and Dexamethasone

Session: A number of Myeloma and Plasma Cell Dyscrasias: Medical and Epidemiological: Poster III

Monday, December 12, 2022

6:00 – 8:00 p.m. CT

Poster Presentation

Influence of Venetoclax Publicity on Medical Efficacy and
Security in Biomarker-Chosen Sufferers with Relapsed or
Refractory A number of Myeloma: Implication for Dose
Choice

Session: A number of Myeloma and Plasma Cell Dyscrasias: Medical and Epidemiological: Poster I

Saturday, December 10, 2022

5:30 – 7:30 p.m. CT

Poster Presentation

Genomic Panorama of t(11;14) in A number of Myeloma

Session: A number of Myeloma and Plasma Cell Dyscrasias: Medical and Epidemiological: Poster III

Monday, December 12, 2022

6:00 – 8:00 p.m. CT

Poster Presentation

Remedy Patterns and Outcomes in Sufferers With
Relapsed/Refractory A number of Myeloma Receiving ≥3
Strains of Remedy: A Actual-World Analysis within the
United States

Session: Outcomes Analysis—Myeloid Malignancies: Poster I

Saturday, December 10, 2022

5:30 – 7:30 p.m. CT

Poster Presentation

Actual-World Remedy Patterns and Outcomes of
Daratumumab Retreatment in A number of Myeloma within the
United States

Session: Outcomes Analysis—Myeloid Malignancies: Poster I

Saturday, December 10, 2022

5:30 – 7:30 p.m. CT

Poster Presentation

A Delicate Machine Studying-Primarily based Method to
Assess A number of Myeloma t(11;14) Genetic Subtype
From Histopathology Photos

Session: Rising Instruments, Strategies and Synthetic Intelligence in Hematology: Poster II

Sunday, December 11, 2022

6:00 – 8:00 p.m. CT

Poster Presentation

Medical Genomic Analyses Exhibit t(11;14)
A number of Myeloma Retains B-Cell Biology and Distinct
Mitochondrial Metabolism That Convey Elevated
Sensitivity to BCL-2 Inhibition by Venetoclax

Session: A number of Myeloma and Plasma Cell Dyscrasias: Fundamental and Translational: Poster I

Saturday, December 10, 2022

5:30 – 7:30 p.m. CT

Poster Presentation

Remedy patterns and total survival (OS) amongst
sufferers with myelodysplastic syndromes (MDS) handled
within the US group oncology setting: a real-world
retrospective observational research

Session: Myelodysplastic Syndromes – Medical and Epidemiological: Poster II

Sunday, December 11, 2022

6:00 – 8:00 p.m. CT

Poster Presentation

Burden of Sickness in Sufferers with Larger-Threat
Myelodysplastic Syndromes by Baseline Transfusion
Standing

Session: Outcomes Analysis—Myeloid Malignancies: Poster III

Monday, December 12, 2022

6:00 – 8:00 p.m. CT

Poster Presentation

ITCC-101/APAL2020D: A Randomized Part 3 Trial of
Fludarabine /Cytarabine/Gemtuzumab Ozogamycin with
or with out Venetoclax in Youngsters with Relapsed Acute
Myeloid leukemia

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

Saturday, December 10, 2022

5:30 – 7:30 p.m. CT

Poster Presentation

Navitoclax

The Mixture of Navitoclax and Ruxolitinib in JAK
Inhibitor-Naïve Sufferers With Myelofibrosis Mediates
Responses Suggestive of Illness Modification

Session: Myeloproliferative Syndromes: Medical and Epidemiological: Newest Knowledge for
Mixture and Rising Focused Therapies in Myelofibrosis

Saturday, December 10, 2022

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

Oral Presentation

Epcoritamab

Analysis of Epcoritamab and Rituximab Mixture
in Preclinical Fashions 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

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

Session: Aggressive Lymphomas: Medical and Epidemiological: Poster I

Saturday, December 10, 2022

5:30 – 7:30 p.m. CT

Poster Presentation

Part 2 Trial to Consider Security of Subcutaneous
Epcoritamab Monotherapy within the Outpatient Setting
Amongst Sufferers with Relapsed or Refractory Diffuse
Grade 1–3a Giant B-cell and Follicular Lymphoma
(EPCORE NHL-6)

Session: Aggressive Lymphomas: Medical and Epidemiological: Poster III

Monday, December 12, 2022

6:00 – 8:00 p.m. CT

Poster Presentation

Part 3 Trial of Subcutaneous Epcoritamab in
Mixture With Rituximab and Lenalidomide (R 2 ) vs
R 2 Amongst Sufferers With Relapsed or Refractory
Follicular Lymphoma (EPCORE FL-1)

Session: Mantle Cell, Follicular, and Different Indolent B Cell Lymphomas: Medical and
Epidemiological: Poster III

Monday, December 12, 2022

6:00 – 8:00 p.m. CT

Poster Presentation

Well being Care Useful resource Utilization and Prices of CAR T
Remedy in Sufferers With Giant B-Cell Lymphoma: a
Retrospective US Claims Database Evaluation

Session: Well being Providers and High quality—Lymphoid Malignancies: Poster I

Saturday, December 10, 2022

5:30 – 7:30 p.m. CT

Poster Presentation

Follicular Lymphoma Remedy Patterns and Outcomes
Over Time: A Actual-World Evaluation in the USA

Session: Outcomes Analysis—Lymphoid Malignancies: Poster I

Saturday, December 10, 2022

5:30 – 7:30 p.m. CT

Poster Presentation

Oblique Comparisons of the Efficacy of Subcutaneous
Epcoritamab vs Chemoimmunotherapy in Sufferers with
Relapsed or Refractory Giant B-cell Lymphoma

Session: Outcomes Analysis—Lymphoid Malignancies: Poster III

Monday, December 12, 2022

6:00 – 8:00 p.m. CT

Poster Presentation

Subcutaneous Epcoritamab in Novel Mixtures with
Antineoplastic Brokers Amongst Sufferers with B-cell Non-
Hodgkin Lymphoma in a Part 1b/2, Multicenter, Open-
Label Research: Assessing Security, Tolerability, and
Preliminary Efficacy (EPCORE NHL-5)

Summary Publication Solely

Subcutaneous Epcoritamab + R-Dhax/C in Sufferers with
Relapsed or Refractory Diffuse Giant B-Cell Lymphoma
Eligible for Autologous Stem Cell Transplant: Up to date
Part 1/2 Outcomes

Session: Aggressive Lymphomas: Potential
Therapeutic Trials: Immune Primarily based and Focused
Therapies in Relapsed/Refractory Giant 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 Sufferers with Relapsed or Refractory
Follicular Lymphoma: Part 1/2 Trial Replace

Session: Mantle Cell, Follicular, and Different Indolent B Cell
Lymphomas: Medical 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 Mixture with
Rituximab + Lenalidomide (R 2 ) for First-Line Remedy
of Follicular Lymphoma: Preliminary Outcomes from Part 1/2
Trial

Session: Mantle Cell, Follicular, and Different Indolent B Cell
Lymphomas: Medical 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:
Analysis 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 comparability of non-Hodgkin lymphomas
in relapsed/refractory versus newly recognized sufferers
utilizing single FFPE slides

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

Sunday, December 11, 2022

6:00 – 8:00 p.m. CT

Poster Presentation

Actual-World Outcomes in Sufferers with Relapsed or
Refractory Diffuse Giant B-Cell Lymphoma Handled with
Customary of Care: A Cota Database Evaluation

Session: Aggressive Lymphomas: Medical and Epidemiological: Poster II

Sunday, December 11, 2022

6:00 – 8:00 p.m. CT

Poster Presentation

Enhancements in Lymphoma Signs and Well being-
Associated High quality of Life in Sufferers with Relapsed or
Refractory Giant B-Cell Lymphoma Handled with
Subcutaneous Epcoritamab (EPCORE NHL-1)

Session: Outcomes Analysis—Lymphoid Malignancies: Poster II

Sunday, December 11, 2022

6:00 – 8:00 p.m. CT

Poster Presentation

Epcoritamab Monotherapy Gives Deep and Sturdy
Responses Together with Minimal Residual Illness (MRD)
Negativity: Novel Subgroup Analyses in Sufferers with
Relapsed/Refractory (R/R) Giant B-Cell Lymphoma (LBCL)

Session: Aggressive Lymphomas: Potential Therapeutic Trials: Poster III

Monday, December 12, 2022

6:00 – 8:00 p.m. CT

Poster Presentation

Subcutaneous Epcoritamab in Sufferers with Richter’s
Syndrome: Early Outcomes from Part 1b/2 Trial
(EPCORE CLL-1)

Session: Continual Lymphocytic Leukemia: Medical and Epidemiological: Focused 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 Part I Research of ABBV-319, an
Antibody-Drug Conjugate Composed of a CD19
Antibody Linked to a Glucocorticoid Receptor
Modulator, in Sufferers with Relapsed or Refractory
B-cell Malignancies

Session: Aggressive Lymphomas: Potential Therapeutic Trials: Poster I

Saturday, December 10, 2022

5:30 – 7:30 p.m. CT

Poster Presentation

ABBV-383

Dose Escalation and Growth of ABBV-383 in
Mixture with Anti-cancer Regimens in Relapsed or
Refractory A number of Myeloma

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

Sunday, December 11, 2022

6:00 – 8:00 p.m. CT

Poster Presentation

A Part 1 First-In-Human research of ABBV-383, a BCMA
x CD3 Bispecific T-cell Redirecting Antibody, as
Monotherapy in Sufferers with Relapsed/Refractory A number of Myeloma

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

Saturday, December 10, 2022

5:30 – 7:30 p.m. CT

Poster Presentation

The ASH 2022 Annual Assembly abstracts can be found right here .

Epcoritamab is an investigational anti-CD20 x CD3 bispecific antibody being co-developed by AbbVie and Genmab as a part of the businesses’ broad oncology collaboration. Epcoritamab just isn’t accredited by any well being authority worldwide presently. Its security and efficacy are underneath analysis as a part of ongoing registrational research.

Navitoclax is an investigational, oral BCL-X L /BCL-2 inhibitor. Navitoclax just isn’t accredited by any well being authority worldwide presently. Its security and efficacy are underneath analysis as a part of ongoing registrational research.

Use of venetoclax in A number of Myeloma (MM) just isn’t accredited by any well being authority worldwide presently. Its security and efficacy are underneath analysis as a part of ongoing registrational research.

A mixture of ibrutinib and venetoclax just isn’t accredited by any well being authority worldwide presently. Its security and efficacy are underneath analysis as a part of ongoing registrational research.

ABBV-319 and ABBV-383 will not be accredited by any well being authority worldwide presently. Their security and efficacy are underneath analysis as a part of ongoing scientific research.

About IMBRUVICA ®
IMBRUVICA ® (ibrutinib) is a once-daily oral remedy that’s collectively developed and commercialized by Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie firm. IMBRUVICA ® blocks the Bruton’s tyrosine kinase (BTK) protein, which is required by regular and irregular B cells, together with particular most cancers cells, to multiply and unfold. By blocking BTK, IMBRUVICA ® might assist transfer irregular B cells out of their nourishing environments and inhibits their proliferation. 7,8,9

IMBRUVICA ® is accredited in additional than 100 international locations and has been used to deal with greater than 250,000 sufferers worldwide. There are greater than 50 company-sponsored scientific trials, together with 18 Part 3 research, over 11 years evaluating the efficacy and security of IMBRUVICA ® .

IMBRUVICA ® was first accredited by the U.S. Meals and Drug Administration (FDA) in November 2013, and right this moment is indicated for grownup sufferers in six illness areas, together with 5 hematologic cancers. These embody indications to deal with adults with CLL/SLL with or with out 17p deletion (del17p), adults with Waldenström’s macroglobulinemia (WM), adults with beforehand handled mantle cell lymphoma (MCL)*, grownup sufferers with beforehand handled marginal zone lymphoma (MZL) who require systemic remedy and have acquired no less than one prior anti-CD20-based remedy*, in addition to grownup and pediatric sufferers one yr and older with beforehand handled power graft versus host illness (cGVHD) after failure of a number of traces of systemic remedy. 6

*Accelerated approval was granted for MCL and MZL based mostly on total response fee. Continued approval for MCL and MZL could also be contingent upon verification and outline of scientific profit in confirmatory trials.

For extra data, go to www.IMBRUVICA.com .

IMPORTANT SAFETY INFORMATION

Earlier than taking IMBRUVICA ® , inform your healthcare supplier about your entire medical circumstances, together with should you:

  • have had current surgical procedure or plan to have surgical procedure. Your healthcare supplier might cease IMBRUVICA ® for any deliberate medical, surgical, or dental process.
  • have bleeding issues
  • have or had coronary heart rhythm issues, smoke, or have a medical situation that will increase your threat of coronary heart illness, akin to hypertension, excessive ldl cholesterol, or diabetes
  • have an an infection
  • have liver issues
  • are pregnant or plan to turn into pregnant. IMBRUVICA ® can hurt your unborn child. If you’ll be able to turn into pregnant, your healthcare supplier will do a being pregnant take a look at earlier than beginning remedy with IMBRUVICA ® . Inform your healthcare supplier in case you are pregnant or suppose you could be pregnant throughout remedy with IMBRUVICA ® .
    • Females who’re capable of turn into pregnant ought to use efficient contraception (contraception) throughout remedy with IMBRUVICA ® and for 1 month after the final dose.
    • Males with feminine companions who’re capable of turn into pregnant ought to use efficient contraception, akin to condoms, throughout remedy with IMBRUVICA ® and for 1 month after the final dose.
  • are breastfeeding or plan to breastfeed. Don’t breastfeed throughout remedy with IMBRUVICA ® and for 1 week after the final dose.

Inform your healthcare supplier about all of the medicines you’re taking, together with prescription and over-the-counter medicines, nutritional vitamins, and natural dietary supplements. Taking IMBRUVICA ® with sure different medicines might have an effect on how IMBRUVICA ® works and might trigger unwanted side effects.

How ought to I take IMBRUVICA ® ?

  • Take IMBRUVICA ® precisely as your healthcare supplier tells you to take it.
  • Take IMBRUVICA ® 1 time a day at about the identical time every day.

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

  • In case your healthcare supplier prescribes IMBRUVICA ® capsules or tablets:
    • Swallow IMBRUVICA ® capsules or tablets entire with a glass of water.
    • Don’t open, break, or chew IMBRUVICA ® capsules.
    • Don’t minimize, crush, or chew IMBRUVICA ® tablets.
  • In case your healthcare supplier prescribes IMBRUVICA ® oral suspension:
    • See the detailed Directions for Use that comes with IMBRUVICA ® oral suspension for details about the right strategy to give a dose to your little one. If in case you have questions on learn how to give IMBRUVICA ® oral suspension, discuss to your healthcare supplier.
    • Don’t use if the carton seal is damaged or lacking.
  • When you miss a dose of IMBRUVICA ® take it as quickly as you keep in mind on the identical day. Take your subsequent dose of IMBRUVICA ® at your common time on the subsequent day. Don’t take additional doses of IMBRUVICA ® to make up for a missed dose.
  • When you take an excessive amount of IMBRUVICA ® name your healthcare supplier or go to the closest hospital emergency room straight away.

What ought to I keep away from whereas taking IMBRUVICA ® ?

  • You shouldn’t drink grapefruit juice, eat grapefruit, or eat Seville oranges (usually utilized in marmalades) throughout remedy with IMBRUVICA ® . These merchandise might enhance the quantity of IMBRUVICA ® in your blood.

What are the attainable unwanted side effects of IMBRUVICA ® ?
IMBRUVICA
® might trigger critical unwanted side effects, together with:

  • Bleeding issues (hemorrhage) are frequent throughout remedy with IMBRUVICA ® , and can be critical and will result in dying. Your threat of bleeding might enhance in case you are additionally taking a blood thinner medication. Inform your healthcare supplier when you’ve got any indicators of bleeding, together with: blood in your stools or black stools (seems to be like tar), pink or brown urine, surprising bleeding, or bleeding that’s extreme or that you simply can’t management, vomit blood or vomit seems to be like espresso grounds, cough up blood or blood clots, elevated bruising, dizziness, weak point, confusion, change in your speech, or a headache that lasts a very long time or extreme headache.
  • Infections can occur throughout remedy with IMBRUVICA ® . These infections may be critical and will result in dying. Inform your healthcare supplier straight away when you’ve got fever, chills, weak point, confusion, or different indicators or signs of an an infection throughout remedy with IMBRUVICA ® .
  • Coronary heart issues. Critical coronary heart rhythm issues (ventricular arrhythmias, atrial fibrillation and atrial flutter), coronary heart failure and dying have occurred in folks handled with IMBRUVICA ® , particularly in individuals who have an an infection, an elevated threat for coronary heart illness, or have had coronary heart rhythm issues previously. Your coronary heart perform might be checked earlier than and through remedy with IMBRUVICA ® . Inform your healthcare supplier should you get any signs of coronary heart issues, akin to feeling as in case your coronary heart is thrashing quick and irregular, lightheadedness, dizziness, shortness of breath, swelling of the ft, ankles or legs, chest discomfort, otherwise you faint. When you develop any of those signs, your healthcare supplier might do assessments to examine your coronary heart and will change your IMBRUVICA ® dose.
  • Hypertension (hypertension). New or worsening hypertension has occurred in folks handled with IMBRUVICA ® . Your healthcare supplier might begin you on blood stress medication or change present medicines to deal with your blood stress.
  • Lower in blood cell counts. Decreased blood counts (white blood cells, platelets, and purple blood cells) are frequent with IMBRUVICA ® , however can be extreme. Your healthcare supplier ought to do month-to-month blood assessments to examine your blood counts.
  • Second main cancers. New cancers have occurred throughout remedy with IMBRUVICA ® , together with cancers of the pores and skin or different organs.
  • Tumor lysis syndrome (TLS). TLS is brought on by the quick breakdown of most cancers cells. TLS could cause kidney failure and the necessity for dialysis remedy, irregular coronary heart rhythm, seizure, and typically dying. Your healthcare supplier might do blood assessments to examine you for TLS.

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

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

The commonest unwanted side effects of IMBRUVICA ® in adults or youngsters 1 yr of age and older with cGVHD embody:

  • tiredness
  • low purple blood cell depend (anemia)
  • bruising
  • diarrhea
  • low platelet depend
  • muscle and joint ache
  • fever
  • muscle spasms
  • mouth sores (stomatitis)
  • bleeding
  • nausea
  • abdomen ache
  • pneumonia
  • headache

Diarrhea is a standard facet impact in individuals who take IMBRUVICA ® . Drink loads of fluids throughout remedy with IMBRUVICA ® to assist cut back your threat of dropping an excessive amount of fluid (dehydration) resulting from diarrhea. Inform your healthcare supplier when you’ve got diarrhea that doesn’t go away.

These will not be all of the attainable unwanted side effects of IMBRUVICA ® . Name your physician for medical recommendation about unwanted side effects. It’s possible you’ll report unwanted side effects to FDA at 1-800-FDA-1088.

Basic details about the protected and efficient use of IMBRUVICA ®
Medicines are typically prescribed for functions apart from these listed in a Affected person Info leaflet. Don’t use IMBRUVICA ® for a situation for which it was not prescribed. Don’t give IMBRUVICA ® to different folks, even when they’ve the identical signs that you’ve. It could hurt them. You possibly can ask your pharmacist or healthcare supplier for details about IMBRUVICA ® that’s written for well being professionals.

Please see the total Essential Product Info .

About VENCLYXTA ® (venetoclax)
VENCLYXTA ® (venetoclax) is a first-in-class medication that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents most cancers cells from present process their pure dying or self-destruction course of, referred to as apoptosis. VENCLYXTA targets the BCL-2 protein and works to assist restore the method of apoptosis.

VENCLYXTA is being developed by AbbVie and Roche. It’s collectively commercialized by AbbVie and Genentech, a member of the Roche Group, within the U.S. and by AbbVie outdoors of the U.S. Collectively, the businesses are dedicated to BCL-2 analysis and to learning venetoclax in scientific trials throughout a number of blood and different cancers. Venetoclax is accredited in additional than 80 international locations, together with the U.S.

Accredited Makes use of of VENCLEXTA

VENCLEXTA is a prescription medication used:

  • to deal with adults with power lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
  • together with azacitidine, or decitabine, or low-dose cytarabine to deal with adults with
    newly recognized acute myeloid leukemia (AML) who:
    • are 75 years of age or older, or
    • produce other medical circumstances that stop the usage of customary chemotherapy.

It’s not identified if VENCLEXTA is protected and efficient in youngsters.

Essential Security Info

What’s crucial data I ought to learn about VENCLEXTA?

VENCLEXTA could cause critical unwanted side effects, together with:

Tumor lysis syndrome (TLS). TLS is brought on by the quick breakdown of most cancers cells. TLS could cause kidney failure, the necessity for dialysis remedy, and will result in dying. Your healthcare supplier will do assessments to examine your threat of getting TLS earlier than you begin taking VENCLEXTA. You’ll obtain different medicines earlier than beginning and through remedy with VENCLEXTA to assist cut back your threat of TLS.

You may additionally must obtain intravenous (IV) fluids into your vein. Your healthcare supplier will do blood assessments to examine for TLS whenever you first begin remedy and through remedy with VENCLEXTA.

You will need to hold your appointments for blood assessments. Inform your healthcare supplier straight away when you’ve got any signs of TLS throughout remedy with VENCLEXTA, together with fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, darkish or cloudy urine, uncommon tiredness, or muscle or joint ache.

Drink loads of water throughout remedy with VENCLEXTA to assist cut back your threat of getting TLS.

Drink 6 to eight glasses (about 56 ounces complete) of water every day, beginning 2 days earlier than your first dose, on the day of your first dose of VENCLEXTA, and every time your dose is elevated.

Your healthcare supplier might delay, lower your dose, or cease remedy with VENCLEXTA when you’ve got unwanted side effects. When restarting VENCLEXTA after stopping for 1 week or longer, your healthcare supplier might once more examine in your threat of TLS and alter your dose.

Who mustn’t take VENCLEXTA?

Sure medicines should not be taken whenever you first begin taking VENCLEXTA and whereas your dose is being slowly elevated due to the chance of elevated TLS.

  • Inform your healthcare supplier about all of the medicines you’re taking, together with prescription and over-the- counter medicines, nutritional vitamins, and natural dietary supplements. VENCLEXTA and different medicines might have an effect on one another inflicting critical unwanted side effects.
  • Don’t begin new medicines throughout remedy with VENCLEXTA with out first speaking together with your healthcare supplier.

Earlier than taking VENCLEXTA, inform your healthcare supplier about your entire medical circumstances, together with should you:

  • have kidney or liver issues.
  • have issues together with your physique salts or electrolytes, akin to potassium, phosphorus, or calcium.
  • have a historical past of excessive uric acid ranges in your blood or gout.
  • are scheduled to obtain a vaccine. You shouldn’t obtain a “dwell vaccine” earlier than, throughout, or after remedy with VENCLEXTA, till your healthcare supplier tells you it’s okay. If you’re undecided about the kind of immunization or vaccine, ask your healthcare supplier. These vaccines might not be protected or might not work as nicely throughout remedy with VENCLEXTA.
  • are pregnant or plan to turn into pregnant. VENCLEXTA might hurt your unborn child. If you’ll be able to turn into pregnant, your healthcare supplier ought to do a being pregnant take a look at earlier than you begin remedy with VENCLEXTA, and you must use efficient contraception throughout remedy and for 30 days after the final dose of VENCLEXTA. When you turn into pregnant or suppose you’re pregnant, inform your healthcare supplier straight away.
  • are breastfeeding or plan to breastfeed. It’s not identified if VENCLEXTA passes into your breast milk.
    Don’t breastfeed throughout remedy with VENCLEXTA and for 1 week after the final dose.

What ought to I keep away from whereas taking VENCLEXTA?

You shouldn’t drink grapefruit juice or eat grapefruit, Seville oranges (usually utilized in marmalades), or starfruit when you are taking VENCLEXTA. These merchandise might enhance the quantity of VENCLEXTA in your blood.

What are the attainable unwanted side effects of VENCLEXTA?

VENCLEXTA could cause critical unwanted side effects, together with:

  • Low white blood cell counts (neutropenia). Low white blood cell counts are frequent with VENCLEXTA, however can be extreme. Your healthcare supplier will do blood assessments to examine your blood counts throughout remedy with VENCLEXTA and will pause dosing.
  • Infections. Loss of life and critical infections akin to pneumonia and blood an infection (sepsis) have occurred throughout remedy with VENCLEXTA. Your healthcare supplier will intently monitor and deal with you straight away when you’ve got a fever or any indicators of an infection throughout remedy with VENCLEXTA.

Inform your healthcare supplier straight away when you’ve got a fever or any indicators of an an infection throughout remedy with VENCLEXTA.

The commonest unwanted side effects of VENCLEXTA when utilized in mixture with obinutuzumab or rituximab or alone in folks with CLL or SLL embody low white blood cell counts; low platelet counts; low purple blood cell counts; diarrhea; nausea; higher respiratory tract an infection; cough; muscle and joint ache; tiredness; and swelling of your arms, legs, fingers, and ft.

The commonest unwanted side effects of VENCLEXTA together with azacitidine or decitabine or low-dose cytarabine in folks with AML embody nausea; diarrhea; low platelet depend; constipation; low white blood cell depend; fever with low white blood cell depend; tiredness; vomiting; swelling of arms, legs, fingers, or ft; fever; an infection in lungs; shortness of breath; bleeding; low purple blood cell depend; rash; abdomen (stomach) ache; an infection in your blood; muscle and joint ache; dizziness; cough; sore throat; and low blood stress.

VENCLEXTA might trigger fertility issues in males. This may increasingly have an effect on your means to father a toddler. Speak to your healthcare supplier when you’ve got considerations about fertility.

These will not be all of the attainable unwanted side effects of VENCLEXTA. Name your physician for medical recommendation about unwanted side effects.

You’re inspired to report unwanted side effects of pharmaceuticals to the FDA. Go to www.fda.gov/medwatch or name 1-800-FDA-1088.

When you can’t afford your remedy, contact genentech-access.com/affected person/manufacturers/venclexta for help.

About Epcoritamab
Epcoritamab is an investigational IgG1-bispecific antibody created utilizing Genmab’s proprietary DuoBody know-how. Genmab’s DuoBody-CD3 know-how is designed to direct cytotoxic T cells selectively to elicit an immune response in the direction of goal cell sorts. Epcoritamab is designed to concurrently 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 goal in lots of B-cell malignancies, together with diffuse giant B-cell lymphoma, follicular lymphoma, mantle cell lymphoma and power lymphocytic leukemia. 6,7 Epcoritamab is being co-developed by Genmab and AbbVie as a part of the businesses’ broad oncology collaboration.

About Navitoclax
Navitoclax is an investigational, oral BCL-X L /BCL-2 inhibitor. The BCL-2 household of proteins are identified regulators of the apoptosis pathway. 3 Navitoclax just isn’t accredited by the U.S. Meals and Drug Administration (FDA) or any Well being Authority worldwide presently. Its security and efficacy are underneath analysis as a part of ongoing Part 2 and registrational Part 3 research.

AbbVie has an intensive late-stage scientific trial program for investigational navitoclax that’s at the moment enrolling. For extra details about enrolling in a scientific trial, please go to us right here .

About AbbVie in Oncology
At AbbVie, we’re dedicated to reworking requirements of look after a number of blood cancers whereas advancing a dynamic pipeline of investigational therapies throughout a variety of most cancers sorts. Our devoted and skilled crew joins forces with progressive companions to speed up the supply of probably breakthrough medicines. We’re evaluating greater than 20 investigational medicines in over 300 scientific trials throughout a few of the world’s most widespread and debilitating cancers. As we work to have a outstanding impression on folks’s lives, we’re dedicated to exploring options to assist sufferers get hold of entry to our most cancers medicines. For extra data, please go to http://www.abbvie.com/oncology and our Blood Most cancers Press package web page.

About AbbVie
AbbVie’s mission is to find and ship progressive medicines that clear up critical well being points right this moment and tackle the medical challenges of tomorrow. We attempt to have a outstanding impression on folks’s lives throughout a number of key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, ladies’s well being and gastroenterology, along with services and products throughout its Allergan Aesthetics portfolio. For extra details about AbbVie, please go to us at www.abbvie.com . Comply with @abbvie on Twitter , Fb , Instagram , YouTube and LinkedIn .

Ahead-Trying Statements
Some statements on this information launch are, or could also be thought-about, forward-looking statements for functions of the Personal Securities Litigation Reform Act of 1995. The phrases “imagine,” “count on,” “anticipate,” “undertaking” and related expressions, amongst others, usually determine forward-looking statements. AbbVie cautions that these forward-looking statements are topic to dangers and uncertainties that will trigger precise outcomes to vary materially from these indicated within the forward-looking statements. Such dangers and uncertainties embody, however will not be restricted to, failure to appreciate the anticipated advantages from AbbVie’s acquisition of Allergan plc (“Allergan”), failure to promptly and successfully combine Allergan’s companies, competitors from different merchandise, challenges to mental property, difficulties inherent within the analysis and growth course of, antagonistic litigation or authorities motion, adjustments to legal guidelines and laws relevant to our trade and the impression of public well being outbreaks, epidemics or pandemics, akin to COVID-19. Extra details about the financial, aggressive, governmental, technological and different elements that will have an effect on AbbVie’s operations is about forth in Merchandise 1A, “Threat Components,” of AbbVie’s 2021 Annual Report on Type 10-Okay, which has been filed with the Securities and Alternate Fee, as up to date by its subsequent Quarterly Stories on Type 10-Q. AbbVie undertakes no obligation to launch publicly any revisions to forward-looking statements on account of subsequent occasions or developments, besides as required by legislation.

View authentic content material: https://www.prnewswire.com/news-releases/abbvie-highlights-blood-cancer-data-from-its-growing-oncology-pipeline-at-the-Sixty fourth-ash-annual-meeting-301685643.html

SOURCE AbbVie



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