NORTH CHICAGO, Ill.,
Nov. 20, 2018 /PRNewswire/
-- AbbVie (NYSE: ABBV), a research-based global
biopharmaceutical company, today announced that data from nearly 40
abstracts, including 13 oral presentations and more than 20 poster
presentations, will be presented during the upcoming 60th ASH
Annual Meeting & Exposition, December
1-4, in San Diego.
Investigators will present data from the Phase 3 iLLUMINATE
trial, which evaluates the safety and efficacy of ibrutinib
(Imbruvica®) in combination with obinutuzumab vs.
chlorambucil in combination with obinutuzumab in patients with
chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma
(SLL) who have not received a prior treatment. In addition,
seven-year data on patients treated
with ibrutinib will be presented, marking the longest follow-up
study for a Bruton's tyrosine kinase (BTK) inhibitor.
"AbbVie's data at the annual ASH meeting shows the progress
we're making in collaboration with scientists, doctors and
patients, toward transforming the
standard of care in numerous blood cancers," said Neil Gallagher, M.D., Ph.D., vice president,
head of global oncology development, AbbVie. "We are pleased to
share important updates from our ibrutinib and venetoclax programs,
where we continue to see the positive impact these two
first-in-class medicines are having in treating blood cancers."
Among the oral presentations is one featuring updated data from
the pivotal Phase 3 MURANO study of venetoclax in combination with
rituximab in patients with relapsed/refractory (R/R) CLL, providing
an additional year of follow-up data of sustained benefits
(progression-free survival and minimal residual disease) for
patients taking the fixed-duration treatment regimen of
approximately two years.1
AbbVie also will present data from multiple studies evaluating
its compounds alone or in novel combinations across other blood
cancers and hematologic diseases. These include CLL, acute myeloid
leukemia (AML), multiple myeloma (MM) and Waldenström's
macroglobulinemia (WM), among others.
Details about AbbVie's oral presentations are as follows:
Abstract
|
Oral Presentation
Timing
|
Ibrutinib
|
Ibrutinib
Treatment in Waldenström's Macroglobulinemia: Follow-up Efficacy
and Safety from the iNNOVATE™
Study; Buske et al.; Abstract #149
|
Saturday, December 1;
1:00 p.m. PT
|
The iR2
Regimen (Ibrutinib, Lenalidomide, and Rituximab) Is Active with a
Manageable Safety Profile in Patients with Relapsed/Refractory
Non-Germinal Center-like Diffuse Large B-Cell Lymphoma; Ramchandren
et al.; Abstract #402
|
Sunday, December 2;
1:15 p.m. PT
|
Up to 7 Years of
Follow-up of Single-Agent Ibrutinib in the Phase 1b/2 PCYC-1102
Trial of First Line and Relapsed/Refractory Patients with Chronic
Lymphocytic Leukemia/Small Lymphocytic Lymphoma; Byrd et al.;
Abstract #3133
|
Sunday, December 2;
6:00-8:00 p.m. PT*
|
Ibrutinib +
Obinutuzumab Versus Chlorambucil + Obinutuzumab as First-Line
Treatment in Patients with Chronic Lymphocytic Leukemia or Small
Lymphocytic Lymphoma (CLL/SLL): Results from Phase 3 iLLUMINATE;
Moreno et al.; Abstract #691
|
Monday, December 3;
10:30 a.m. PT
|
Venetoclax
|
|
|
Durability of
Responses on Continuous Therapy and Following Drug Cessation in
Deep Responders with Venetoclax and Rituximab; Brander et al.;
Abstract #183
|
Saturday, December 1;
2:30 p.m. PT
|
MURANO Trial
Establishes Feasibility of Time-Limited Venetoclax-Rituximab (VenR)
Combination Therapy in Relapsed/Refractory (R/R) Chronic
Lymphocytic Leukemia (CLL); Seymour et al.; Abstract
#184
|
Saturday, December 1;
2:45 p.m. PT
|
Venetoclax with
Low-Dose Cytarabine Induces Rapid, Deep, and Durable Responses in
Previously Untreated Older Adults with AML Ineligible for Intensive
Chemotherapy; Wei et al.; Abstract #284
|
Sunday, December 2;
7:45 a.m. PT
|
Venetoclax in
Combination with Hypomethylating Agents Induces Rapid, Deep, and
Durable Responses in Patients with AML Ineligible for Intensive
Therapy; Pollyea et al.; Abstract #285
|
Sunday, December 2;
8:00 a.m. PT
|
Phase 2 Study of
Venetoclax Plus Carfilzomib and Dexamethasone in Patients with
Relapsed/Refractory Multiple Myeloma; Costa et al.; Abstract
#303
|
Sunday, December 2;
8:00 a.m. PT
|
Safety and
Efficacy of Venetoclax Combined with Rituximab, Ifosfamide,
Carboplatin and Etoposide Chemoimmunotherapy (VICER) for Treatment
of Relapsed Diffuse Large B Cell Lymphoma: Results from the Phase 1
Study; Caimi et al.; Abstract #397
|
Sunday, December 2;
12:00 p.m. PT
|
Combination of
Enasidenib and Venetoclax Shows Superior Anti-Leukemic Activity
Against IDH2 Mutated AML in Patient-Derived Xenograft Models;
Cathelin et al.; Abstract #562
|
Monday, December 3;
7:45 a.m. PT
|
First Prospective
Data on Impact of Minimal Residual Disease on Long-Term Clinical
Outcomes after Venetoclax Plus Rituximab Versus Bendamustine Plus
Rituximab: Phase 3 MURANO Study; Kater et al.; Abstract
#695
|
Monday, December 3;
11:30 a.m. PT
|
Venetoclax Plus
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and
Prednisolone (R-CHOP) Improves Outcomes in BCL-2 Positive
First-Line Diffuse Large B-Cell Lymphoma (DLBCL): First Safety,
Efficacy and Biomarker Analyses from the Phase 2 CAVALLI Study;
Morschhauser et al.; Abstract #782
|
Monday, December 3;
3:00 p.m. PT
|
Safety, Efficacy,
Pharmacokinetic (PK) and Biomarker Analysis of BCL-2 Inhibitor
Venetoclax (Ven) Plus MDM2 Inhibitor Idasanutlin (idasa) in
Patients (pts) with Relapsed or Refractory (R/R) AML: A Phase Ib,
Non-Randomized, Open-Label Study; Daver et al.; Abstract
#767
|
Monday, December 3;
3:45 p.m. PT
|
About VENCLEXTA®/VENCLYXTO®
(venetoclax)
VENCLEXTA®/VENCLYXTO® (venetoclax) is a
first-in-class medicine that selectively binds and inhibits the
B-cell lymphoma-2 (BCL-2) protein.2 In some blood
cancers and other cancerous tumors, BCL-2 builds up and prevents
cancer cells from undergoing their natural death or
self-destruction process, which is called apoptosis.2 VENCLEXTA/VENCLYXTO
targets the BCL-2 protein and works to 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 and
other cancers.
VENCLEXTA/VENCLYXTO is approved in more than 50 countries,
including the U.S. AbbVie and Roche are currently working with
regulatory agencies around the world to bring this medicine to
additional eligible patients in need.
Important
VENCLEXTA® (venetoclax tablets) US
Safety Information2
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 health care provider will do
tests to check your risk of getting TLS 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
health care provider will do blood tests in your first 5 weeks of
treatment to check you for TLS during treatment with VENCLEXTA. It
is important to keep your appointments for blood tests. Tell your
health care 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 when taking 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.
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 tumor lysis syndrome.
- Tell your health care 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 health care provider.
Before taking VENCLEXTA, tell your health care 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 health care provider tells you it is okay. If you are
not sure about the type of immunization or vaccine, ask your health
care 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 health
care provider should do a pregnancy test before you start treatment
with VENCLEXTA, and you should use effective birth control during
treatment and for 30 days after the last dose of VENCLEXTA. If you
become pregnant or think you are pregnant, tell your health care
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.
What should I avoid while taking VENCLEXTA?
You should
not drink grapefruit juice, 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 count (neutropenia). Low white
blood cell counts are common with VENCLEXTA, but can also be
severe. Your health care provider will do blood tests to check your
blood counts during treatment with VENCLEXTA. Tell your health care
provider right away if you have a fever or any signs of an
infection while taking VENCLEXTA.
The most common side effects of VENCLEXTA when used in
combination with rituximab include low white blood cell
count, diarrhea, upper respiratory tract infection, cough,
tiredness, and nausea.
The most common side effects of VENCLEXTA when used alone
include low white blood cell count, diarrhea,
nausea, upper respiratory tract infection, low red blood
cell count, tiredness, low platelet count, muscle and joint
pain, swelling of your arms, legs, hands, and feet, and cough.
VENCLEXTA may cause fertility problems in males. This may affect
your ability to father a child. Talk to your health care provider
if you have concerns about fertility.
These are not all the possible side effects of VENCLEXTA. Tell
your health care provider if you have any side effect that bothers
you or that does not go away.
People are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch or
call 1-800-FDA-1088.
The full U.S. prescribing information,
including Medication Guide, for VENCLEXTA can be
found here. Globally, prescribing information varies;
refer to the individual country product label for complete
information.
About IMBRUVICA® (ibrutinib) in the
U.S.3
IMBRUVICA (ibrutinib) is a first-in-class,
oral, once-daily therapy that mainly works by inhibiting a protein
called Bruton's tyrosine kinase (BTK). BTK is a key signaling
molecule in the B-cell receptor signaling complex that plays an
important role in the survival and spread of malignant B cells.4 IMBRUVICA blocks signals that tell
malignant B cells to multiply and spread uncontrollably.
IMBRUVICA is FDA-approved in six distinct patient populations:
chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma
(SLL), Waldenström's macroglobulinemia (WM), along with
previously-treated mantle cell lymphoma (MCL), previously-treated
marginal zone lymphoma (MZL) and previously-treated chronic
graft-versus-host disease (cGVHD).3
- IMBRUVICA was first approved for adult patients with MCL who
have received at least one prior therapy in November 2013.
- Soon after, IMBRUVICA was initially approved in adult CLL
patients who have received at least one prior therapy in
February 2014. By July 2014, the therapy received approval for
adult CLL patients with 17p deletion, and by March 2016, the therapy was approved as a
frontline CLL treatment.
- IMBRUVICA was approved for adult patients with WM in
January 2015.
- In May 2016, IMBRUVICA was
approved in combination with bendamustine and rituximab (BR) for
adult patients with CLL/SLL.
- In January 2017, IMBRUVICA was
approved for adult patients with MZL who require systemic therapy
and have received at least one prior anti-CD20-based therapy.
- In August 2017, IMBRUVICA was
approved for adult patients with cGVHD that failed to respond to
one or more lines of systemic therapy.
- In August 2018, IMBRUVICA plus
rituximab was approved for adult patients with WM.
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.
IMBRUVICA has been granted four Breakthrough Therapy
Designations from the U.S. FDA. This designation is intended to
expedite the development and review of a potential new drug for
serious or life-threatening diseases.5 IMBRUVICA was one
of the first medicines to receive FDA approval via the new
Breakthrough Therapy Designation pathway.
IMBRUVICA is being studied alone and in combination with other
treatments in several blood and solid tumor cancers and other
serious illnesses. IMBRUVICA has one of the most robust clinical
oncology development programs for a single molecule in the
industry, with more than 130 ongoing clinical trials. There are
approximately 30 ongoing company-sponsored trials, 14 of which are
in Phase 3, and more than 100 investigator-sponsored trials and
external collaborations that are active around the world. To date,
more than 120,000 patients around the world have been treated with
IMBRUVICA in clinical practice and clinical trials.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Hemorrhage: Fatal bleeding events have occurred in
patients treated with IMBRUVICA®. Grade 3 or higher
bleeding events (intracranial hemorrhage [including subdural
hematoma], gastrointestinal bleeding, hematuria, and
post-procedural hemorrhage) have occurred in 3% of patients, with
fatalities occurring in 0.3% of 1,011 patients exposed to
IMBRUVICA® in clinical trials. Bleeding events of any
grade, including bruising and petechiae, occurred in 44% of
patients treated with IMBRUVICA®.
The mechanism for the bleeding events is not well
understood.
IMBRUVICA® may increase the risk of hemorrhage in
patients receiving antiplatelet or anticoagulant therapies and
patients should be monitored for signs of bleeding.
Consider the benefit-risk of withholding IMBRUVICA®
for at least 3 to 7 days pre and post-surgery depending upon the
type of surgery and the risk of bleeding.
Infections: Fatal and non-fatal infections (including
bacterial, viral, or fungal) have occurred with
IMBRUVICA® therapy. Grade 3 or greater infections
occurred in 24% of 1,011 patients exposed to IMBRUVICA®
in clinical trials. Cases of progressive multifocal
leukoencephalopathy (PML) and Pneumocystis jirovecii
pneumonia (PJP) have occurred in patients treated with
IMBRUVICA®. Consider prophylaxis according to standard
of care in patients who are at increased risk for opportunistic
infections.
Monitor and evaluate patients for fever and infections and treat
appropriately.
Cytopenias: Treatment-emergent Grade 3 or 4 cytopenias
including neutropenia (23%), thrombocytopenia (8%), and anemia (3%)
based on laboratory measurements occurred in patients with B-cell
malignancies treated with single agent IMBRUVICA®.
Monitor complete blood counts monthly.
Cardiac Arrhythmias: Fatal and serious cardiac
arrhythmias have occurred with IMBRUVICA® therapy. Grade
3 or greater ventricular tachyarrhythmias occurred in 0.2% of
patients, and Grade 3 or greater atrial fibrillation and atrial
flutter occurred in 4% of 1,011 patients exposed to
IMBRUVICA® in clinical trials. These events have
occurred particularly in patients with cardiac risk factors,
hypertension, acute infections, and a previous history of cardiac
arrhythmias.
Periodically monitor patients clinically for cardiac
arrhythmias. Obtain an ECG for patients who develop arrhythmic
symptoms (e.g., palpitations, lightheadedness, syncope, chest pain)
or new onset dyspnea. Manage cardiac arrhythmias appropriately, and
if it persists, consider the risks and benefits of
IMBRUVICA® treatment and follow dose modification
guidelines.
Hypertension: Hypertension has occurred in 12% of 1,011
patients treated with IMBRUVICA® in clinical trials with
a median time to onset of 5 months (range, 0.03 to 22 months).
Monitor patients for new onset hypertension or hypertension that is
not adequately controlled after starting IMBRUVICA®.
Adjust existing anti-hypertensive medications and/or initiate
anti-hypertensive treatment as appropriate.
Second Primary Malignancies: Other malignancies (9%)
including non-skin carcinomas (2%) have occurred in 1,011 patients
treated with IMBRUVICA® in clinical trials. The most
frequent second primary malignancy was non-melanoma skin cancer
(6%).
Tumor Lysis Syndrome: Tumor lysis syndrome has been
infrequently reported with IMBRUVICA® therapy. Assess
the baseline risk (e.g., high tumor burden) and take appropriate
precautions.
Monitor patients closely and treat as appropriate.
Embryo-Fetal Toxicity: Based on findings in animals,
IMBRUVICA® can cause fetal harm when administered to a
pregnant woman. Advise women to avoid becoming pregnant while
taking IMBRUVICA® and for 1 month after cessation of
therapy. If this drug is used during pregnancy or if the patient
becomes pregnant while taking this drug, the patient should be
apprised of the potential hazard to a fetus. Advise men to avoid
fathering a child during the same time period.
ADVERSE REACTIONS
B-cell malignancies: The most common adverse reactions
(≥20%) in patients with B-cell malignancies (MCL, CLL/SLL, WM and
MZL) were thrombocytopenia (58%)*, neutropenia (58%)*, diarrhea
(42%), anemia (39%)*, rash (31%), musculoskeletal pain (31%),
bruising (31%), nausea (28%), fatigue (27%), hemorrhage (23%), and
pyrexia (20%).
The most common Grade 3 or 4 adverse reactions (≥5%) in patients
with B-cell malignancies (MCL, CLL/SLL, WM and MZL) were
neutropenia (36%)*, thrombocytopenia (15%)*, and pneumonia
(10%).
Approximately 6% (CLL/SLL), 14% (MCL), 14% (WM) and 10% (MZL) of
patients had a dose reduction due to adverse reactions.
Approximately 4%-10% (CLL/SLL), 9% (MCL), and 7% (WM [5%] and MZL
[13%]) of patients discontinued due to adverse reactions.
cGVHD: The most common adverse reactions (≥20%) in
patients with cGVHD were fatigue (57%), bruising (40%), diarrhea
(36%), thrombocytopenia (33%)*, stomatitis (29%), muscle spasms
(29%), nausea (26%), hemorrhage (26%), anemia (24%)*, and pneumonia
(21%).
The most common Grade 3 or 4 adverse reactions (≥5%) reported in
patients with cGVHD were fatigue (12%), diarrhea (10%), neutropenia
(10%)*, pneumonia (10%), sepsis (10%), hypokalemia (7%), headache
(5%), musculoskeletal pain (5%), and pyrexia (5%).
Twenty-four percent of patients receiving IMBRUVICA®
in the cGVHD trial discontinued treatment due to adverse reactions.
Adverse reactions leading to dose reduction occurred in 26% of
patients.
*Treatment-emergent decreases (all grades) were based on
laboratory measurements and adverse reactions.
DRUG INTERACTIONS
CYP3A Inhibitors: Dose adjustments may be
recommended.
CYP3A Inducers: Avoid coadministration with strong CYP3A
inducers.
SPECIFIC POPULATIONS
Hepatic Impairment (based on Child-Pugh criteria): Avoid
use of IMBRUVICA® in patients with severe baseline
hepatic impairment. In patients with mild or moderate impairment,
reduce IMBRUVICA® dose.
Please click here for full Prescribing
Information.
About AbbVie in Oncology
At AbbVie, we strive to
discover and develop medicines that deliver transformational
improvements in cancer treatment by uniquely combining our deep
knowledge in core areas of biology with cutting-edge technologies,
and by working together with our partners – scientists, clinical
experts, industry peers, advocates, and patients. We remain focused
on delivering these transformative advances in treatment across
some of the most debilitating and widespread cancers. We are also
committed to exploring solutions to help patients obtain access to
our cancer medicines. With the acquisitions of Pharmacyclics in
2015 and Stemcentrx in 2016, our research and development efforts,
and through collaborations, AbbVie's oncology portfolio now
consists of marketed medicines and a pipeline containing multiple
new molecules being evaluated worldwide in more than 200 clinical
trials and more than 20 different tumor types. For more
information, please visit http://www.abbvie.com/oncology.
About AbbVie
AbbVie is a global, research and
development-based biopharmaceutical company committed to developing
innovative advanced therapies for some of the world's most complex
and critical conditions. The company's mission is to use its
expertise, dedicated people and unique approach to innovation to
markedly improve treatments across four primary therapeutic areas:
immunology, oncology, virology and neuroscience. In more than
75 countries, AbbVie employees are working every day to advance
health solutions for people around the world. For more information
about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on
Twitter, Facebook, LinkedIn or Instagram.
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, challenges to
intellectual property, competition from other products,
difficulties inherent in the research and development process,
adverse litigation or government action, and changes to laws and
regulations applicable to our industry. 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 2017 Annual Report on Form
10-K, which has been filed with the Securities and Exchange
Commission. 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 Seymour J, et al. MURANO Trial established
feasibility of time-limited venetoclax-rituximab (VenR) combination
therapy in relapsed/refractory (R/R) chronic lymphocytic leukemia
(CLL). Presented at the 2018 American Society of Hematology Annual
Meeting & Exposition; December 1,
2018; San Diego.
2 VENCLEXTA (venetoclax tablets) [Package
Insert]. North Chicago, Ill.:
AbbVie Inc.
3 IMBRUVICA US Prescribing Information, August 2018
4 Genetics Home Reference (2017). Isolated growth
hormone
deficiency. http://ghr.nlm.nih.gov/condition/isolated-growth-hormone-deficiency.
Accessed November 2018.
5 U.S. Food and Drug Administration. Fact Sheet:
Breakthrough Therapies. Available
from: https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FDASIA/ucm329491.htm.
Accessed November 2018
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