- AbbVie will present 46 abstracts for six
investigational and approved medicines across eight cancer
types
- A five-year update from the CLL14 Phase 3
VENCLYXTO®/VENCLEXTA® (venetoclax) and
obinutuzumab in previously untreated patients with chronic
lymphocytic leukemia (CLL) will be presented at EHA
- Nine abstracts showing results from ongoing trials studying
investigational epcoritamab will be presented at both
meetings
NORTH
CHICAGO, Ill., May 12, 2022
/PRNewswire/ -- AbbVie (NYSE: ABBV) will present 46 abstracts
across eight types of cancer during the upcoming American Society
of Clinical Oncology (ASCO) Annual Meeting (June 3-7) and the European Hematology Association
(EHA) Congress (June 9-17).
"AbbVie continues working to transform the standards of care for
cancer treatments as a result of our commitment to patients,
innovation and partnerships," said Mohamed
Zaki, M.D., Ph.D., vice president and global head of
oncology development, AbbVie. "The data being presented at ASCO and
EHA will provide a look at our continued research advancements in
cancer across our expanding oncology portfolio and
pipeline."
During both meetings, AbbVie will present nine abstracts
evaluating epcoritamab (DuoBody®-CD3xCD20), an investigational
subcutaneous bispecific antibody, including data from multiple arms
of the ongoing phase 1b/2 EPCORE™
NHL-2 clinical trial, evaluating the safety and preliminary
efficacy of epcoritamab in combination with standard-of-care
therapies for the treatment of various types of B-cell non-Hodgkin
lymphoma (NHL). Additionally, data will be presented from the Phase
2 REFINE study of investigational compound navitoclax +
ruxolitinib in JAK inhibitor-treatment-naïve patients with
myelofibrosis.
At this year's ASCO annual meeting AbbVie will be presenting on
its solid tumor research with data from telisotuzumab vedotin
(Teliso-V) in non-small cell lung cancer.
During the EHA Congress, the five-year update from the CLL14
trial of a combined regimen of venetoclax + obinutuzumab versus
obinutuzumab + chlorambucil comparing the efficacy and safety in
participants with untreated chronic lymphocytic leukemia (CLL) will
be presented.
Details about presentations are as follows:
ASCO 2022
Abstracts
|
Abstract
|
Presentation
Details
All Times in
CT
|
Ibrutinib
|
Primary Results From
the Double-Blind,
Placebo-Controlled, Phase III SHINE Study of
Ibrutinib in Combination With Bendamustine-
Rituximab (BR) and R Maintenance as a
First-Line Treatment for Older Patients (Pts)
with Mantle Cell Lymphoma (MCL)
|
Session:
Hematologic Malignancies—
Lymphoma and Chronic Lymphocytic
Leukemia
Friday, June 3,
2022
1:00 – 4:00 p.m.
CT
Oral
|
Fixed-Duration (FD)
Ibrutinib (I) Plus
Venetoclax (V) for First-Line (1L) Treatment
(tx) of Chronic Lymphocytic Leukemia
(CLL)/Small Lymphocytic Lymphoma (SLL)
3-year Follow-up From the FD Cohort of
the
Phase 2 CAPTIVATE Study
|
Session:
Hematologic Malignancies—
Lymphoma and Chronic Lymphocytic
Leukemia
Saturday, June 4,
2022
8:00 – 11:00 a.m.
CT
Poster
|
Phase 1/2 Study of
Zilovertamab and Ibrutinib
in Mantle Cell Lymphoma (MCL) or Chronic
Lymphocytic Leukemia (CLL)
|
Session:
Hematologic Malignancies—
Lymphoma and Chronic Lymphocytic
Leukemia
Saturday, June 4,
2022
3:00 – 4:30 p.m.
CT
Poster
|
Prognostic Testing and
Treatment Patterns in
Black Patients (Pts) With Chronic
Lymphocytic Leukemia (CLL) From the
Inform CLL Prospective
Observational Registry
|
Abstract Publication
Only
|
Upper Gastrointestinal
(GI) Morbidity, Peptic
Ulcer Risk, and Proton Pump Inhibitor
(PPI)/H2 Blocker (H2B) Use in Patients (Pts)
Treated With Bruton's Tyrosine Kinase
Inhibitors (BTKis) During Routine Care
|
Abstract Publication
Only
|
Characteristics and
Clinical Outcomes
Among Patients Receiving Either Ibrutinib or
Anti-CD20 Monotherapy as First-Line (1L)
Treatment for Chronic Lymphocytic Leukemia
(CLL) / Small Lymphocytic Lymphoma (SLL)
A Retrospective Analysis in Community
Oncology Practice
|
Abstract Publication
Only
|
Real-World Clinical
Outcomes in Patients
Receiving Either Ibrutinib or Chemo-
Immunotherapy (CIT) as First-Line (1L)
Treatment for Chronic Lymphocytic Leukemia
(CLL) / Small Lymphocytic Lymphoma (SLL)
A Retrospective Analysis
|
Abstract Publication
Only
|
Venetoclax
|
Efficacy and Safety of
Venetoclax
in Combination With Azacitidine or Decitabine in
an Outpatient Setting in Patients with
Untreated Acute Myeloid Leukemia
|
Session:
Hematologic Malignancies—
Leukemia, Myelodysplastic Syndromes, and
Allotransplant
Saturday, June 4,
2022
8:00 – 11:00 a.m.
CT
Poster
|
Epcoritamab*
|
First-Line Treatment
(Tx) With Subcutaneous
(SC) Epcoritamab (Epco) + R-CHOP in
Patients (Pts) With High-Risk Diffuse Large
B-Cell Lymphoma (DLBCL): Phase 1/2
Data
Update
|
Session:
Hematologic Malignancies—
Lymphoma and Chronic Lymphocytic
Leukemia
Saturday, June 4,
2022
8:00 – 11:00 a.m.
CT
Poster
|
Subcutaneous
Epcoritamab With Rituximab +
Lenalidomide (R2) in Patients (Pts) with
Relapsed or Refractory (R/R) Follicular
Lymphoma (FL): Update from Phase 1/2 Trial
|
Session:
Hematologic Malignancies—
Lymphoma and Chronic Lymphocytic
Leukemia
Saturday, June 4,
2022
8:00 – 11:00 a.m.
CT
Poster
|
Subcutaneous
Epcoritamab + R-DHAX/C in
Patients (Pts) With Relapsed or Refractory
(R/R) Diffuse Large B-Cell Lymphoma
(DLBCL) Who Are Eligible for Autologous
Stem Cell Transplant (ASCT): Preliminary
Phase 1/2 Results
|
Session:
Hematologic Malignancies—
Lymphoma and Chronic Lymphocytic
Leukemia
Saturday, June 4,
2022
8:00 – 11:00 a.m.
CT
Poster
|
Epcoritamab (Epco) with
Gemcitabine +
Oxaliplatin (GemOx) in Patients (Pts) With
Relapsed or Refractory (R/R) Diffuse Large
B‑Cell Lymphoma (DLBCL) Ineligible for
Autologous Stem Cell Transplant (ASCT)
Induces High Response Rate Even in Pts
Failing CAR T Therapy
|
Session:
Hematologic Malignancies—
Lymphoma and Chronic Lymphocytic
Leukemia
Saturday, June 4,
2022
8:00 – 11:00 a.m.
CT
Poster
|
Navitoclax
|
Navitoclax Plus
Ruxolitinib in JAK inhibitor-
Naïve Patients (Pts) With Myelofibrosis:
Preliminary Safety and Efficacy in a
Multicenter, Open-Label Phase 2 Study
|
Session: Hematologic
Malignancies –
Leukemia, Myelodysplastic Syndromes, and
Allotransplant
8:00 – 11:00 a.m.
CT
Poster
Saturday, June 4,
2022
1:15 – 2:45 p.m.
CT
Poster
Discussion
|
Lemzoparlimab
|
Lemzoparlimab (Lemzo)
with Venetoclax
(Ven) and/or Azacitidine (Aza) in Patients
(Pts) With Acute Myeloid Leukemia (AML) or
Myelodysplastic Syndromes (MDS)
A Phase 1b Dose Escalation
Study
|
Session:
Hematologic Malignancies—
Leukemia, Myelodysplastic Syndromes, and
Allotransplant
Saturday, June 4,
2022
8:00 – 11:00 a.m.
CT
Poster
|
Teliso-V
|
Phase 1/1B study of
Telisotuzumab Vedotin
(Teliso-V) + Osimertinib (Osi), After Failure
on Prior Osi, in Patients (Pts) With Advanced,
c-Met Overexpressing, EGFR-Mutated Non-
Small Cell Lung Cancer (NSCLC).
|
Session: Lung Cancer –
Non-Small Cell
Metastatic
Monday, June 6,
2022
8:00 – 11:00 a.m.
CT
Poster
1:15 – 2:45 p.m.
CT
Poster
Discussion
|
Telisotuzumab Vedotin
(Teliso-V)
Monotherapy in Patients (Pts) With
Previously Treated c-Met-Overexpressing
(OE) Advanced Non-Small Cell Lung Cancer
(NSCLC)
|
Session: Lung Cancer –
Non-Small Cell
Metastatic
Monday, June 6,
2022
8:00 – 11:00 a.m.
CT
Poster
1:15 – 2:45 p.m.
CT
Poster
Discussion
|
The ASCO 2022 Annual Meeting abstracts are available here.
EHA 2022
Abstracts
|
Abstract
|
Presentation
Details
All Times in
CT
|
Ibrutinib
|
Immune Restoration and
Synergistic Activity
with First-Line (1L) Ibrutinib (IBR) Plus
Venetoclax (VEN): Translational Analyses of
CAPTIVATE Trial Patients with CLL
|
Session: CLL:
Translational Research
Saturday, June 11,
2022
9:30 – 10:45 a.m.
CT
Oral
|
Primary Results From
the Phase 3 Shine Study
of Ibrutinub in Combination With
Bendamustine-Rituximab (BR) and R
Maintenance as a First-Line Treatment for
Older Patients With Mantle-Cell Lymphoma
|
Session: Indolent and
Mantle Cell Lymphoma
Saturday, June 11,
2022
4:30 - 5:45 a.m.
CT
Oral
|
Absence of BTK, BCL2,
and PLCG2 Mutations
in Relapsing Chronic Lymphocytic Leukemia
(CLL) After First-Line Treatment with Fixed-
Duration Ibrutinib (I) Plus Venetoclax (V)
|
Session: Chronic
lymphocytic leukemia and
related disorders - Clinical
Friday, June 10, 2022
9:30-10:45 a.m.
CT
Poster
|
Fixed-Duration (FD)
Ibrutinib + Venetoclax for
First-Line Treatment of Chronic Lymphocytic
Leukemia (CLL)/Small Lymophocytic
Lymphoma (SLL): 3-Year Follow-up From the
Phase 2 CAPTIVATE Study FD Cohort
|
Friday, June 10,
2022
9:30 – 10:45 a.m.
CT
Poster
|
Cross-Trial Analysis of
Fixed-Duration Ibrutinib
(I) Plus Venetoclax (V) Vs Fludarabine (F),
Cyclophosphamide (C), And Rituximab (R) As
First-Line Treatment for Chronic Lymphocytic
Leukemia (CLL)
|
Session: Chronic
lymphocytic leukemia and
related disorders - Clinical
Abstract Publication Only
|
Venetoclax***
|
Venetoclax-Obinutuzumab
for Previously
Untreated Chronic Lymphocytic Leukemia: 5-
Year Results of the Randomized CLL14 Study
|
Session: CLL:
Clinical
Sunday, June 12,
2022
4:30 - 5:45 a.m.
CT
Oral
|
VIALE-M: A Randomized,
Double-Blind, 2-Arm,
Multicenter, Phase 3 Study of Venetoclax and
Oral Azacitidine Versus Oral Azacitidine as
Maintenance Therapy for Patients With Acute
Myeloid Leukemia in First Remission After
Intensive Chemotherapy
|
Session: Acute myeloid
leukemia - Clinical
Friday, June 10, 2022
9:30 – 10:45 a.m.
CT
Poster
|
VIALE-T: A Randomized,
Open-Label, Phase 3
Study of Venetoclax in Combination With
Azacitidine After Allogeneic Stem Cell
Transplantation in Patients With Acute Myeloid
Leukemia
|
Session: Acute myeloid
leukemia - Clinical
Friday, June 10, 2022
9:30 – 10:45 a.m.
CT
Poster
|
The Impact of
Post-Remission Granulocyte
Colony-Stimulating Factor Use in the Phase 3
Studies of Venetoclax Combination Treatments
in Patients With Newly Diagnosed Acute
Myeloid Leukemia
|
Session: Acute myeloid
leukemia - Clinical
Friday, June 10, 2022
9:30 – 10:45 a.m.
CT
Poster
|
Transfusion
Independence Among Newly
Diagnosed Acute Myeloid Leukemia Patients
Receiving Venetoclax-Based Combinations Vs
Other Therapies: Results from the AML Real
World Evidence (ARC) Initiative
|
Session: Acute myeloid
leukemia - Clinical
Friday, June 10, 2022
9:30 – 10:45 a.m.
CT
Poster
|
Clinical Outcomes in
Patients With
Higher-Risk Myelodysplastic Syndromes
Receiving Hypomethylating Agents:
a Large Population-Based Analysis
|
Session:
Myelodysplastic syndromes - Clinical
Friday, June 10, 2022
9:30 – 10:45 a.m.
CT
Poster
|
Venetoclax in Patients
With Chronic
Lymphocytic Leukemia With 17p Deletion: 6-
Year Follow-Up and Genomic Analyses in a
Pivotal Phase 2 Trial
|
Session: CLL:
Clinical
Friday, June 12,
2022
4:30 - 5:45 a.m.
CT
Oral
|
Treatment Sequences and
Outcomes of
Patients (Pts) with CLL Treated With Targeted
Agents in Real-World Settings
|
Session: Chronic
lymphocytic leukemia and
related disorders - Clinical
Friday, June 10, 2022
9:30 – 10:45 a.m.
CT
Poster
|
Healthcare Resource
Utilization and Costs Of
Therapy With Fixed-Duration Venetoclax
Among CLL Patients (Pts)
|
Abstract Publication
Only
|
Transcriptomic
Characterization of MRD
Response and Non-Response in Patients (Pts)
Treated With
Fixed-Duration Venetoclax-
Obinutuzumab
|
Session: CLL:
Translational
Saturday, June 11,
2022
9:30 – 10:45 a.m.
CT
Oral
|
Fixed-Duration (FD)
Ibrutinib (I) Plus
Venetoclax (V) for First-Line (1L) Treatment
(Tx) of Chronic Lymphocytic Leukemia (CLL) /
Small Lymphocytic Lymphoma (SLL): 3-Year
Follow-Up From the FD Cohort of the Phase 2
CAPTIVATE Study
|
Friday, June 10,
2022
9:30 – 10:45 a.m.
CT
Poster
|
PedAL/EuPAL
International Collaboration to
Improve the Outcome of Children With
Relapsed or Refractory Acute Myeloid
Leukemia (AML)
|
Session: Acute myeloid
leukemia - Clinical
Friday, June 10, 2022
9:30 – 10:45 a.m.
CT
Poster
|
Cross-Trial Analysis of
Fixed-Duration Ibrutinib
(I) Plus Venetoclax (V) Versus Fludarabine (F),
Cyclophosphamide (C), and Rituximab (R) as
First-Line Treatment for Chromic Lymphoma
Leukemia (CLL)
|
Session: Chronic
lymphocytic leukemia and
related disorders - Clinical
Abstract Publication Only
|
Safety and
Effectiveness of Venetoclax
Monotherapy in Relapsed/Refractory CLL
Patients (Pts) With or Without Risk-Associated
Genetic Markers – Data from the Observational
VeRVe Study
|
Session: Chronic
lymphocytic leukemia and
related disorders - Clinical
Friday, June 10, 2022
9:30 – 10:45 a.m.
CT
Poster
|
Effectiveness and
Safety of Venetoclax in
Combination with Rituximab (VenR) in
Relapsed/Refractory CLL Patients With or
Without Risk-Associated Genetic Markers –
Data from the Observational VeRVe Study
|
Session: Chronic
lymphocytic leukemia and
related disorders - Clinical
Friday, June 10, 2022
9:30 – 10:45 a.m.
CT
Poster
|
Real-Life Efficacy and
Safety of Venetoclax
Monotherapy in Relapsed/Refractory Chronic
Lymphocytic Leukemia – Interim Analysis of
Multicentric Study VERONE
|
Session: Chronic
lymphocytic leukemia and
related disorders - Clinical
Friday, June 10, 2022
9:30 – 10:45 a.m.
CT
Poster
|
Venetoclax in
Combination With Obinutuzumab
in First Line Chromic Leukemia in Argentina: A
Cost-Effectiveness Analysis
|
Session: Quality of
life, palliative care, ethics
and health economics
Friday, June 10, 2022
9:30 – 10:45 a.m.
CT
Poster
|
Lemzoparlimab**
|
Lemzoparlimab (Lemzo)
With Venetoclax (Ven)
And/Or Azacitidine (Aza) in Patients (Pts) With
Acute Myeloid Leukemia (AML) or
Myelodysplastic Syndromes (MDS): A Phase
1b Dose Escalation Study
|
Session: Acute myeloid
leukemia - Clinical
Friday, June 10, 2022
9:30 – 10:45 a.m.
CT
Poster
|
Epcoritamab*
|
Assessing Safety,
Tolerability, and Efficacy of
Subcutaneous Epcoritamab in Novel
Combinations With Anti-Neoplastic Agents in
Patients (Pts) With Non-Hodgkin Lymphoma in
an Open-Label Phase 1B/2 Study
|
Session: Aggressive
Non-Hodgkin lymphoma
- Clinical
Abstract Publication Only
|
Subcutaneous (SC)
Epcoritamab + R-CHOP in
Previously Untreated Patients (Pts) With High-
Risk Diffuse Large B-Cell Lymphoma (DLBCL):
Phase 1/2 Data Update
|
Friday, June 10,
2022
9:30 - 10:45 a.m.
CT
Poster
|
Subcutaneous (SC)
Epcoritamab With
Rituximab + Lenalidomide (R2) in Patients
(Pts) With Relapsed or Refractory (R/R)
Follicular Lymphoma (FL): Update From Phase
1/2 Trial
|
Friday, June 10,
2022
4:30 – 5:45 p.m.
CT
Poster
|
Subcutaneous (SC)
Epcoritamab + R-DHAX/C
in Patients (Pts) With Relapsed or Refractory
(R/R) Diffuse Large B-Cell Lymphoma (DLBCL)
Who Are Eligible For Autologous Stem Cell
Transplant (ASCT): Preliminary Phase 1/2 Data
|
Friday, June 10,
2022
9:30 – 10:45 a.m.
CT
Poster
|
Epcoritamab With
Gemcitabine + Oxaliplatin
(GemOx) in Patients (Pts) With Relapsed or
Refractory (R/R) Diffuse Large B Cell
Lymphoma (DLBCL) Who Are Ineligible for
Autologous Stem Cell Transplant (ASCT):
Phase 1/2 Data
|
Friday, June 10,
2022
9:30 – 10:45 a.m.
CT
Poster
|
Navitoclax
|
Navitoclax Monotherapy
in Patients (Pts) With
MF Previously Treated With JAK-2 Inhibitors:
Safety and Tolerability
|
Session:
Myeloproliferative neoplasms - Clinical
Friday, June 10, 2022
9:30 – 10:45 a.m.
CT
Poster
|
Navitoclax plus
ruxolitinib in JAK Inhibitor-naïve
Patients with Myelofibrosis: Preliminary Safety
and Efficacy in a Multicenter, Open-label Phase
2 Study
|
Session: Treatments and
complications in MPN
Friday, June 11, 2022
4:30 – 5:45 a.m.
CT
Oral
|
The EHA 2022 Congress abstracts are available here.
*Epcoritamab is being co-developed by AbbVie and Genmab
as part of the companies' broad oncology collaboration.
**Lemzoparlimab is investigational and being developed through a
comprehensive clinical development plan for hematologic
malignancies and solid tumor in collaboration with AbbVie and
I-Mab.
***Use of venetoclax in myelodysplastic syndromes (MDS) is not
approved and its safety and efficacy have not been evaluated by
regulatory authorities.
About Ibrutinib (IMBRUVICA®)
IMBRUVICA® (ibrutinib) is a once-daily oral
medication that is jointly developed and commercialized by
Pharmacyclics LLC, an AbbVie Company and Janssen Biotech, Inc.
IMBRUVICA® blocks the Bruton's tyrosine kinase
(BTK) protein, which is needed by normal and abnormal B cells, to
multiply and spread.1,2 By blocking BTK, IMBRUVICA
may help move abnormal B cells out of their nourishing environments
in the lymph nodes, bone marrow, and other organs.3
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 ongoing or completed 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 adults with CLL/small
lymphocytic lymphoma (SLL) with or without 17p deletion (del17p)
and adults with Waldenström's macroglobulinemia (WM), as well as
adult patients 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 patients with previously
treated chronic graft-versus-host disease (cGVHD) after failure of
one or more lines of systemic therapy.4
*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.
Since 2019, the National Comprehensive Cancer
Network® (NCCN®), recommends ibrutinib
(IMBRUVICA®) as a preferred regimen for first-line
treatment of CLL/SLL, with Category 1 status for previously
untreated patients without del17p. Additionally,
IMBRUVICA® is a preferred treatment regimen for
previously untreated patients with del17p. Since January 2020,
the NCCN Guidelines recommend IMBRUVICA® as a
category 2A preferred regimen for the treatment of
relapsed/refractory MCL. Since September 2020, the NCCN
Guidelines recommend IMBRUVICA® with or without
rituximab as a Category 1 preferred regimen for both untreated and
previously treated WM patients.
For more information, visit www.IMBRUVICA.com.
*Accelerated approval was granted for the MCL and MZL
indications based on overall response rate. Continued approval for
MCL and MZL may be contingent upon verification and description of
clinical benefit in confirmatory trials.
Important Side Effect
Information5
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.
- 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.
- Take IMBRUVICA® at about the same time each
day.
- 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®.
- 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.
- 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 increased
risk for heart disease, have an infection, or who have had heart
rhythm problems in the past. 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 a test to check your heart (ECG)
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.
- 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 with cGVHD include:
- tiredness
- bruising
- diarrhea
- mouth sores (stomatitis)
- muscle spasms
- nausea
- pneumonia
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 click here for full Prescribing Information.5
About VENCLEXTA®/VENCLYXTO®
(venetoclax)6
VENCLEXTA®/VENCLYXTO® (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. VENCLXEXTA/VENCLYXTO targets the BCL-2 protein and works
to help restore the process of apoptosis.
VENCLEXTA/VENCLYXTO 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
cancers. Venetoclax is approved in more than 80 countries,
including the U.S.
Important Safety Information7
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 at least 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
drug 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.
The full U.S. prescribing information, including Medication
Guide, for VENCLEXTA® can be
found here.
Indications and Important Venclyxto (venetoclax) EU Safety
Information8
Indications
VENCLYXTO in combination with obinutuzumab is indicated for the
treatment of adult patients with previously untreated chronic
lymphocytic leukaemia (CLL).
VENCLYXTO in combination with rituximab is indicated for the
treatment of adult patients with CLL who have received at least one
prior therapy.
VENCLYXTO monotherapy is indicated for the treatment of CLL:
- In the presence of 17p deletion or TP53 mutation in
adult patients who are unsuitable for or have failed a B-cell
receptor pathway inhibitor, or
- In the absence of 17p deletion or TP53 mutation in adult
patients who have failed both chemoimmunotherapy and a B-cell
receptor pathway inhibitor
Venclyxto in combination with a hypomethylating agent is
indicated for the treatment of adult patients with newly diagnosed
acute myeloid leukaemia (AML) who are ineligible for intensive
chemotherapy.
Contraindications
Hypersensitivity to the active substance or to any of the
excipients is contraindicated. Concomitant use of strong
CYP3A inhibitors at initiation and during the dose-titration phase
due to increased risk for tumour lysis syndrome (TLS). Concomitant
use of preparations containing St. John's wort as
Venclyxto efficacy may be reduced.
Special Warnings & Precautions for Use
Tumour Lysis syndrome, including fatal events, has occurred in
patients when treated with Venclyxto. For CLL and AML, please refer
to the indication-specific recommendations for prevention of TLS in
the Venclyxto summary of product characteristic (SmPC).
Patients should be assessed for risk and should receive
appropriate prophylaxis, monitoring, and management for TLS.
The risk of TLS is a continuum based on multiple factors, including
comorbidities. Venclyxto poses a risk for TLS at initiation and
during the dose-titration phase. Changes in electrolytes consistent
with TLS that require prompt management can occur as early as 6 to
8 hours following the first dose of Venclyxto and at each dose
increase. During postmarketing surveillance, TLS, including fatal
events, has been reported after a single 20 mg dose of
venetoclax.
Neutropenia (grade 3 or 4) has been reported. Complete
blood counts should be monitored throughout the treatment
period.
In patients with AML, neutropenia (grade 3 or 4) is common
before starting treatment. The neutrophil counts can worsen with
Venetoclax in combination with a hypomethylating agent. Neutropenia
can recur with subsequent cycles of therapy. Dose modification and
interruptions for cytopenias are dependent on remission status.
For CLL and AML, please refer to the indication-specific
recommendations for dose modifications for toxicities in the
Venclyxto SmPC.
Serious infections including sepsis with fatal outcome have been
reported. Monitoring of any signs and symptoms of infection is
required. Suspected infections should receive prompt treatment,
including antimicrobials and dose interruption or reduction as
appropriate.
Live vaccines should not be administered during treatment or
thereafter until B-cell recovery.
Drug Interactions
In CLL and AML CYP3A inhibitors may increase Venclyxto plasma
concentrations.
In CLL, at initiation and dose-titration phase, Strong CYP3A
inhibitors are contraindicated due to increased risk for TLS and
moderate CYP3A inhibitors should be avoided. If moderate CYP3A
inhibitors must be used, please refer to the recommendations for
dose modifications in the Venclyxto SmPC.
In AML, please refer to the AML-specific recommendation for dose
modifications for potential interactions with CYP3A inhibitors, in
the VENCLYXTO SmPC.
Avoid concomitant use of P-gp and BCRP inhibitors at initiation
and during the dose titration phase.
CYP3A4 inducers may decrease Venclyxto plasma
concentrations. Avoid coadministration with strong or
moderate CYP3A inducers. These agents may decrease venetoclax
plasma concentrations.
Co-administration of bile acid sequestrants with VENCLYXTO is
not recommended as this may reduce the absorption of VENCLYXTO.
Adverse Reactions
CLL
The most commonly occurring adverse reactions (≥20%) of any
grade in patients receiving venetoclax in the combination studies
with obinutuzumab or rituximab were neutropenia, diarrhoea, and
upper respiratory tract infection. In the monotherapy
studies, the most common adverse reactions were
neutropenia/neutrophil count decreased, diarrhoea, nausea, anaemia,
fatigue, and upper respiratory tract infection.
The most frequently occurring serious adverse reactions (≥2%) in
patients receiving venetoclax in combination with obinutuzumab or
rituximab were pneumonia, sepsis, febrile neutropenia, and
TLS. In the monotherapy studies, the most frequently reported
serious adverse reactions (≥2%) were pneumonia and febrile
neutropenia.
Discontinuations due to adverse reactions occurred in 16% of
patients in both combination studies (CLL14 and MURANO). In the
monotherapy studies with venetoclax, 11% of patients discontinued
due to adverse reactions.
Dosage reductions due to adverse reactions occurred in 21% of
patients treated with the combination of venetoclax and
obinutuzumab in the CLL14 study, in 15% of patients treated with
the combination of venetoclax and rituximab in the Murano study,
and in 14% of patients treated with venetoclax in the monotherapy
studies. The most common adverse reaction that led to dose
interruptions was neutropenia.
AML
The most commonly occurring adverse reactions (>=20%) of any
grade in patients receiving venetoclax in combination with
azacitidine or decitabine in the VIALE-A and M14-358, respectively,
were thrombocytopenia, neutropenia, febrile neutropenia, nausea,
diarrhoea, vomiting, anaemia, fatigue, pneumonia, hypokalaemia, and
decreased appetite, haemorrhage, dizziness/syncope, hypotension,
headache, abdominal pain, and anaemia.
The most frequently reported serious adverse reactions (≥5%) in
patients receiving venetoclax in combination with azacitidine were
febrile neutropenia, pneumonia, sepsis and haemorrhage. In M14-358,
the most frequently reported serious adverse reactions (≥5%) were
febrile neutropenia, pneumonia, bacteraemia and sepsis.
Discontinuations due to adverse reactions occurred in 24 % of
patients treated with venetoclax in combination with azacitidine in
the VIALE-A study, and 26% of patients treated with venetoclax in
combination with decitabine in the M14-358 study, respectively.
Dosage reductions due to adverse reactions occurred in 2% of
patients in VIALE-A, and in 6% of patients in M14-358. Venetoclax
dose interruptions due to adverse reactions occurred in 72% and 65
% of patients, respectively. The most common adverse reaction that
led to dose interruption (>10%) of Venetoclax in VIALE-A, were
febrile neutropenia, neutropenia, pneumonia, and
thrombocytopenia. The most common adverse reactions that led
to dose interruption (≥5%) of venetoclax in M14-358 were febrile
neutropenia, neutropenia/neutrophil count decreased, pneumonia,
platelet count decreased, and white blood cell count decreased.
Special Populations
Patients with reduced renal function (CrCl <80 mL/min) may
require more intensive prophylaxis and monitoring to reduce the
risk of TLS at initiation and during the dose-titration phase.
Safety in patients with severe renal impairment (CrCl <30
mL/min) or on dialysis has not been established, and a recommended
dose for these patients has not been determined.
For patients with severe (Child-Pugh C) hepatic impairment,
a dose reduction of at least 50% throughout treatment is
recommended.
Venclyxto may cause embryo-fetal harm when administered to a
pregnant woman. Advise nursing women to discontinue breastfeeding
during treatment.
This is not a complete summary of all safety information. See
Venclyxto (venetoclax) SmPC at www.ema.europa.eu. Globally,
prescribing information varies; refer to the individual country
product label for complete information.
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.9 Epcoritamab was developed with
selective, silencing mutations that may limit, systemic
non-specific activity.10 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.11,12 Epcoritamab is being
co-developed by AbbVie and Genmab as part of the companies' broad
oncology collaboration.
About Lemzoparlimab
Lemzoparlimab is investigational
and being developed through a comprehensive clinical development
plan for hematologic malignancies and solid tumor in collaboration
with AbbVie and I-Mab.
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.13 Navitoclax
is not approved by any regulatory authority. Its safety and
efficacy are under evaluation as part of ongoing Phase 2 and
registrational Phase 3 studies.
AbbVie is currently recruiting for two Phase 3 trials of
navitoclax (TRANSFORM-1 and TRANSFORM-2) in combination with
ruxolitinib for the treatment of myelofibrosis that will enroll
more than 500 patients. The company anticipates pivotal trial
readouts and regulatory submission for navitoclax in 2023.
About Telisotuzumab Vedotin
Teliso-V is an
investigational antibody-drug conjugate (ADC) targeting c-Met, a
receptor tyrosine kinase that is overexpressed in tumors including
NSCLC. Teliso-V is not approved by any regulatory authority and its
safety and efficacy are under evaluation.
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.
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.
1 Genetics Home Reference. Isolated growth
hormone deficiency.
http://ghr.nlm.nih.gov/condition/isolated-growth-hormone-deficiency.
Accessed November 2020.
2 Turetsky, et al. Single cell imaging of Bruton's
Tyrosine Kinase using an irreversible inhibitor. Scientific
Reports. volume 4, Article number: 4782 (2014)
3 de Rooij MF, Kuil A, Geest CR, et al. The
clinically active BTK inhibitor PCI-32765 targets B-cell receptor-
and chemokine-controlled adhesion and migration in chronic
lymphocytic leukemia. Blood. 2012;119(11):2590-2594.
4 IMBRUVICA U.S. Prescribing Information,
April 2020.
5 IMBRUVICA U.S. Prescribing Information,
April 2020.
6 Summary of Product Characteristics for VENCLYXTO
(venetoclax). Ludwigshafen, Germany: AbbVie Deutschland GmbH
& Co. KG.
7 ISI verified against ISI listed on venclexta.com
24Oct2021
8 Summary of Product Characteristics for VENCLYXTO
(venetoclax). Ludwigshafen, Germany: AbbVie Deutschland GmbH
& Co. KG.
9 "Diffuse Large B-Cell Lymphoma." Lymphoma
Research Foundation,
https://www.lymphoma.org/aboutlymphoma/nhl/dlbcl/; date accessed:
11 February 2022.
10 van der Horst, H.J., de Jonge, A.V., Hiemstra,
I.H. et al. Epcoritamab induces potent anti-tumor activity against
malignant B-cells from patients with DLBCL, FL and MCL,
irrespective of prior CD20 monoclonal antibody treatment. Blood
Cancer J. 11, 38 (2021).
https://doi.org/10.1038/s41408-021-00430-6
11 Rafiq, Sarwish, et al. "Comparative Assessment
of Clinically Utilized CD20-Directed Antibodies in Chronic
Lymphocytic Leukemia Cells Reveals Divergent NK Cell, Monocyte, and
Macrophage Properties." J. Immunol. (Baltimore, Md. 1950), U.S. National
Library of Medicine, 15 Mar.
2013, www.ncbi.nlm.nih.gov/pmc/articles/PMC3631574/.
12 Singh, Vijay, et al. "Development of Novel
Anti-Cd20 Monoclonal Antibodies and Modulation in Cd20 Levels on
Cell Surface: Looking to Improve Immunotherapy Response." J Cancer
Sci Ther., U.S. National Library of Medicine, Nov.
2015, www.ncbi.nlm.nih.gov/pmc/articles/PMC4939752/.
13 Tsujimoto Y. (1998). Role of Bcl-2 family
proteins in apoptosis: apoptosomes or mitochondria?. Genes to
cells: devoted to molecular & cellular mechanisms, 3(11),
697–707. https://doi.org/10.1046/j.1365-2443.1998.00223.x
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