NORTH CHICAGO, Ill.,
Dec. 5, 2020 /PRNewswire/ -- AbbVie
(NYSE: ABBV) today announced new data from the Phase 2 CAPTIVATE
(PCYC-1142) clinical trial evaluating
IMBRUVICA® (ibrutinib) in combination with
VENCLEXTA®/VENCLYXTO® (venetoclax) in
previously untreated patients with chronic lymphocytic leukemia
(CLL) or small lymphocytic lymphoma (SLL) during an oral
presentation session at the virtual 2020 American Society of
Hematology (ASH) Annual Meeting (Abstract #123). The one-year
disease-free survival (DFS) rate in patients randomized to placebo
or ibrutinib after completing the combination regimen provides data
to support a fixed-duration treatment that can offer CLL/SLL
patients remission and time off treatment.
"These results show the ibrutinib plus venetoclax combination
providing continued disease-free survival for CLL patients once
treatment is complete," said Dr. William
Wierda, M.D., Professor, Department of Leukemia,
University of Texas MD Anderson Cancer
Center and principal study investigator. "It will be really
exciting for patients to have a potential option in the future that
can put them into remission and time off treatment."
These findings build on the previously reported results showing
that this first-line combination regimen for CLL resulted in high
rates of undetectable minimal residual disease (uMRD) in both
peripheral blood (PB) (75% of patients) and in bone marrow (BM)
(72% of patients). Undetectable MRD is defined as little to no
cancer cells found after treatment. In the Confirmed uMRD group,
one-year DFS rate was not significantly different for patients
randomized to placebo (95.3%; 95% CI 82.7-98.8) versus ibrutinib
(100%; 95% CI 100-100) (P=0.1475).
During the overall study period across all-treated patients
(with median treatment duration of 29 months), most common grade
3/4 adverse events (≥5% of patients) were neutropenia (36%),
hypertension (10%), thrombocytopenia (5%), and diarrhea (5%). The
safety profile of the combination was consistent with known adverse
events for ibrutinib and venetoclax individually and no new safety
signals emerged.
"IMBRUVICA and VENCLEXTA/VENCLYXTO, individually, have truly
transformed the way CLL and some other blood cancers are treated.
Today, CLL can be treated without chemotherapy in the form of an
oral pill, which is a remarkable advancement, compared to standards
of care over the last decade," said Mohamed Zaki, M.D., Ph.D.,
vice president and global head of oncology development, AbbVie.
"The results from this study will add to the evidence required for
the development of this combination regimen as a potential new
treatment option for CLL."
CLL is one of the two most common forms of leukemia in adults
and is a type of cancer that can develop from cells in the bone
marrow that later mature into certain white blood cells (called
lymphocytes).1 While these cancer cells start
in the bone marrow, they then later spread into the blood. The
prevalence of CLL is approximately 115,000 patients in the U.S.
with approximately 20,000 newly diagnosed patients every
year.2,3 CLL is
predominately a disease of the elderly, with a median age at
diagnosis ranging from 65-70 years.4
According to the Leukemia & Lymphoma Society, MRD refers to
the small number of cancer cells that remain in the body after
treatment.5 The number
of remaining cells may be so small that they do not cause any
physical signs or symptoms and often cannot even be detected
through traditional methods, this is known as undetectable MRD
(uMRD). Doctors use MRD/uMRD to measure the effectiveness of
treatment and to predict which patients are at risk of relapse.
There are additional ongoing company-sponsored trials exploring
the potential of ibrutinib and venetoclax in combination for CLL
treatment, including the Phase 3 GLOW study. Results from the
ongoing GLOW study, assessing the ibrutinib plus venetoclax
combination in comparison to chlorambucil plus obinutuzumab for
first-line treatment of patients with CLL or SLL (NCT03462719),
will be presented at an upcoming congress.
About CAPTIVATE
The CAPTIVATE study MRD cohort
evaluated 164 patients between the ages of 18 and 70 years old with
previously untreated CLL/SLL. Patients received 3 cycles of
ibrutinib lead-in followed by 12 cycles of ibrutinib +
venetoclax (Ibr 420 mg/day PO; Ven ramp-up to 400 mg/day PO).
Patients with confirmed uMRD (defined as uMRD serially over ≥3
cycles, and in both PB and BM) after 12 cycles of ibrutinib +
venetoclax were randomized 1:1 to receive double-blind
treatment with placebo or ibrutinib. Patients who did not meet
the definition of confirmed uMRD were randomized 1:1 to receive
open-label treatment with ibrutinib or continued ibrutinib +
venetoclax. Primary endpoint was 1-year DFS rate in the confirmed
uMRD patients randomized to placebo vs ibrutinib; DFS was defined
as survival without progression or MRD relapse (which was defined
as an MRD level of 10-2). Key secondary endpoints were
rates of uMRD (<10-4 by 8-color flow cytometry),
response per iwCLL, adverse events (AEs), as well as
progression-free survival (PFS). The safety profile of the
combination was consistent with known adverse events for ibrutinib
and venetoclax individually and no new safety signals emerged.
The depth of response achieved with this regimen is reflected in
the 30-month progression-free survival (PFS) rate of ~95% across
all treated patients, including the subset receiving placebo after
the fixed duration treatment.
About Ibrutinib (IMBRUVICA®)
IMBRUVICA (ibrutinib) is a once-daily, first-in-class BTK inhibitor
that is administered orally, and is jointly developed and
commercialized by Pharmacyclics, LLC, an AbbVie Company, and
Janssen Biotech, Inc. (Janssen). The BTK protein sends important
signals that tell B cells to mature and produce antibodies. BTK
signaling is needed by specific cancer cells to multiply and
spread.6,7 By
blocking BTK, IMBRUVICA may help move abnormal B cells out of their
nourishing environments in the lymph nodes, bone marrow, and other
organs.8
Since its launch in 2013, IMBRUVICA has received 11 FDA
approvals across six disease areas: chronic lymphocytic leukemia
(CLL) with or without 17p deletion (del17p); small lymphocytic
lymphoma (SLL) with or without del17p; Waldenström
macroglobulinemia; previously-treated patients with mantle cell
lymphoma (MCL)*; previously-treated patients with marginal zone
lymphoma (MZL) who require systemic therapy and have received at
least one prior anti-CD20-based therapy* – and previously-treated
patients with chronic graft-versus-host disease (cGVHD) after
failure of one or more lines of systemic therapy.9
IMBRUVICA is now approved in 101 countries and has been used to
treat more than 200,000 patients worldwide across its approved
indications. IMBRUVICA is the only FDA-approved medicine in WM and
cGVHD. 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. IMBRUVICA was one of the
first medicines to receive FDA approval via the Breakthrough
Therapy Designation pathway.
As of early 2019, the National Comprehensive Cancer
Network® (NCCN®), a not-for-profit
alliance of 28 leading cancer centers devoted to patient care,
research, and education, recommends ibrutinib (IMBRUVICA) as a
preferred regimen for the initial treatment of CLL/SLL and has
Category 1 treatment status for treatment-naïve patients without
deletion 17p. In February 2020, the NCCN
Guidelines® were updated to elevate IMBRUVICA with
or without rituximab from other recommended regimens to a preferred
regimen for the treatment of relapsed/refractory MCL. In
September 2020, the NCCN guidelines
were updated to elevate IMBRUVICA with or without rituximab as the
only Category 1 preferred regimen for treatment-naïve WM
patients.
IMBRUVICA is being studied alone and in combination with other
treatments in several blood and solid tumor cancers and other
serious illnesses. IMBRUVICA is the most comprehensively studied
BTK inhibitor, with more than 150 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. 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 Information
Before taking
IMBRUVICA®, tell your healthcare provider about all of
your medical conditions, including if you:
- have had recent surgery or plan to have surgery. Your
healthcare provider may stop IMBRUVICA® for any
planned medical, surgical, or dental procedure.
- have bleeding problems.
- have or had heart rhythm problems, smoke, or have a medical
condition that increases your risk of heart disease, such as high
blood pressure, high cholesterol, or diabetes.
- have an infection.
- have liver problems.
- are pregnant or plan to become pregnant.
IMBRUVICA® can harm your unborn baby. If you are
able to become pregnant, your healthcare provider will do a
pregnancy test before starting treatment with
IMBRUVICA®. Tell your healthcare provider if you are
pregnant or think you may be pregnant during treatment with
IMBRUVICA®.
-
- Females who are able to become pregnant should use
effective birth control (contraception) during treatment with
IMBRUVICA® and for 1 month after the last
dose.
- Males with female partners who are able to become
pregnant should use effective birth control, such as condoms,
during treatment with IMBRUVICA® and for 1 month
after the last dose.
- are breastfeeding or plan to breastfeed. Do not breastfeed
during treatment with IMBRUVICA® and for 1 week
after the last dose.
Tell your healthcare provider about all the medicines you
take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements. Taking
IMBRUVICA® with certain other medicines may affect
how IMBRUVICA® works and can cause side
effects.
How should I take IMBRUVICA®?
- Take IMBRUVICA® exactly as your healthcare
provider tells you to take it.
- Take IMBRUVICA® 1 time a day.
- 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 rhythm problems (ventricular arrhythmias, atrial
fibrillation and atrial flutter). Serious heart rhythm
problems 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 rhythm problems, such as feeling as if
your heart is beating fast and irregular, lightheadedness,
dizziness, shortness of breath, 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.
About VENCLEXTA® (venetoclax)
VENCLEXTA® (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. VENCLEXTA 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 and
other cancers. VENCLEXTA/VENCLYXTO is approved in more than 50
countries, including the U.S.
Uses and Important VENCLEXTA® (venetoclax) U.S. Safety
Information10
Uses
VENCLEXTA is a prescription medicine used:
- to treat adults with chronic lymphocytic leukemia (CLL) or
small lymphocytic lymphoma (SLL).
- in combination with azacitidine, or decitabine, or low-dose
cytarabine to treat adults with newly-diagnosed acute myeloid
leukemia (AML) who:
-
- are 75 years of age or older, or
- have other medical conditions that prevent the use of standard
chemotherapy.
It is not known if VENCLEXTA is safe and effective in
children.
Important Safety Information
What is the most
important information I should know about
VENCLEXTA?
VENCLEXTA can cause serious side effects,
including:
Tumor lysis syndrome (TLS). TLS is caused
by the fast breakdown of cancer cells. TLS can cause kidney
failure, the need for dialysis treatment, and may lead to death.
Your healthcare provider will do tests to check your risk of
getting TLS before you start taking VENCLEXTA. You will receive
other medicines before starting and during treatment with VENCLEXTA
to help reduce your risk of TLS. You may also need to receive
intravenous (IV) fluids into your vein. Your healthcare provider
will do blood tests to check for TLS when you first start treatment
and during treatment with VENCLEXTA.It is important to keep your
appointments for blood tests. Tell your healthcare provider right
away if you have any symptoms of TLS during treatment with
VENCLEXTA, including fever, chills, nausea, vomiting, confusion,
shortness of breath, seizures, irregular heartbeat, dark or cloudy
urine, unusual tiredness, or muscle or joint pain.
Drink plenty of water during treatment with VENCLEXTA to help
reduce your risk of getting TLS. Drink 6 to 8 glasses (about 56
ounces total) of water each day, starting 2 days before your first
dose, on the day of your first dose of VENCLEXTA, and each time
your dose is increased.
Your healthcare provider may delay, decrease your dose, or stop
treatment with VENCLEXTA if you have side effects.
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 drugs
to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
If you cannot afford your medication, contact
genentech-access.com/patient/brands/venclexta for assistance.
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 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. AbbVie's
oncology portfolio now consists of marketed medicines and a
pipeline containing multiple new molecules being evaluated
worldwide in more than 300 clinical trials and more than 20
different tumor types. 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 2019 Annual Report on Form 10-K, which has been filed with
the Securities and Exchange Commission, as updated by its
subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no
obligation to release publicly any revisions to forward-looking
statements as a result of subsequent events or developments, except
as required by law.
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December 2018.
2 IMS Database [Data on File].
3 National Cancer Institute. Cancer Stat Facts:
Leukemia - Chronic Lymphocytic Leukemia
(CLL). https://seer.cancer.gov/statfacts/html/clyl.html.
Accessed December 2018.
4 Shanafelt, et al. Age at Diagnosis and the
Utility of Prognostic Testing in Patients with Chronic Lymphocytic
Leukemia (CLL). Cancer. 2010; 116(20): 4777–4787.
5 Leukemia and Lymphoma Society Minimal Residual
Disease (MRD) Fact Sheet
https://www.lls.org/sites/default/files/National/USA/Pdf/Publications/FS35_MRD_Final_2019.pdf
6 Genetics Home Reference. Isolated growth
hormone
deficiency. http://ghr.nlm.nih.gov/condition/isolated-growth-hormone-deficiency.
Accessed November 2020.
7 Turetsky, et al. Single cell imaging of
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Scientific Reports. volume 4, Article number: 4782 (2014).
8 de Rooij MF, Kuil A, Geest CR, et al. The
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[Package Insert]. North Chicago,
IL.: AbbVie Inc.
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