- Updated data presented at ASH include CAPTIVATE and
GLOW studies and real-world evidence abstracts
Ill., Dec. 10,
2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today
announced new and updated data across clinical and real-world
studies in chronic lymphocytic leukemia (CLL). Presentations
featured during the 64th American Society of Hematology
(ASH) Annual Meeting and Exposition will include two clinical
trials investigating once daily, fixed-duration treatment with
IMBRUVICA® (ibrutinib) plus
VENCLEXTA®/VENCLYXTO® (venetoclax) (I+V) in
adults with CLL and several analyses from real-word data evaluating
front-line treatment in CLL.
"As the only Bruton's Tyrosine Kinase inhibitor (BTKi) studied
across many clinical trials, including up to eight years of
follow-up data in CLL and small lymphocytic lymphoma (SLL), these
latest data add to overall evidence for IMBRUVICA," said
James Dean, M.D., Ph.D., global
development lead and executive medical director, Pharmacyclics LLC,
an AbbVie company. "These findings further inspire our commitment
to the continued investigation of IMBRUVICA in the treatment of
patients with CLL."
Presentations will include the five-year median follow-up
efficacy and safety data from the minimal residual disease (MRD)
Cohort of the Phase 2 CAPTIVATE study (Abstract #92)1
and data on MRD kinetics from the randomized, open-label Phase 3
GLOW study (Abstract #93).2 Additionally, new data from
three studies evaluating the impact of IMBRUVICA®
treatment in the real-world setting will be presented (Abstracts
Five-Year Update from the CAPTIVATE Study Adds to Clinical
Data Investigating the Potential of a Fixed-Duration
The MRD Cohort of the Phase 2 CAPTIVATE (NCT02910583) study
evaluated 164 patients age 70 years or younger with previously
untreated CLL; those who achieved confirmed undetectable minimal
residual disease (uMRD) after completion of I+V fixed-duration
treatment were randomly assigned to placebo (PBO) (n=43), or
continued IMBRUVICA® treatment
(n=43).1 For patients with confirmed uMRD, median
time on study was 56 months (PBO arm range, 40‒65 months;
IMBRUVICA® arm range, 25‒68 months); median
post-randomization follow-up was 41 months in both
arms.1 At four years of follow-up, estimated
progression-free survival (PFS) was 88 percent (95 percent
Confidence Interval [CI], 74-95, seven progressive disease events)
with PBO compared to 95 percent (95 percent CI, 82-99, two
progressive disease events) with continued IMBRUVICA®
treatment.1 Additionally, at year four, patients in
the PBO arm of the study achieved an estimated overall survival
(OS) rate of 100 percent (95 percent CI, NA) compared to 98 percent
(95 percent CI, 84-99.7) in the IMBRUVICA® treatment
No new atrial fibrillation (AF) or Grade three or higher
hemorrhage events occurred in the PBO arm during the three year
post-randomization period, and one patient in the
IMBRUVICA® arm had AF in the second year
post-randomization.1 During the three-year
post-randomization period, adverse events (AEs) of any grade for
patients treated with IMBRUVICA® were arthralgia (4/41),
hypertension (2/41), neutropenia (1/41) and diarrhea (1/41). No new
grade three or higher hemorrhage events occurred in either
The Data of IMBRUVICA® in the Treatment of CLL
Through Real-World Studies
An oral presentation (Abstract #797) will report findings
comparing time to next treatment (TTNT) in patients with CLL who
received first-line treatment with IMBRUVICA® or
acalabrutinib based on a real-world study utilizing electronic
A poster presentation (Abstract #1809) will highlight results
from a pooled analysis of the RESONATE-2 (NCT01722487), ECOG1912
(NCT02048813), and iLLUMINATE (NCT02264574) clinical studies
investigating the comparison of OS in previously untreated CLL
patients treated with IMBRUVICA® to that of the
available age-matched general population, as well as comparative
results of OS in patients treated with IMBRUVICA® versus
chemotherapy and chemoimmunotherapy.4
Thirdly, the final analysis from the informCLL™ real-world (RW)
registry, which assessed RW outcomes with first-line
IMBRUVICA® versus chemoimmunotherapy (CIT) in
patients with CLL and SLL, will be presented as a poster (Abstract
#3132).5 The informCLL™ registry enrolled 1,459
patients, of whom 59 percent were previously
untreated.5 First-line treatment with
IMBRUVICA® was associated with longer TTNT than
with CIT and sustained benefit, with up to four years of
follow-up.5 In the IMBRUVICA® cohort
(n=383), serious adverse events (AEs) occurred in 144 patients (38
percent), most commonly (greater or equal to three percent of
patients) pneumonia (six percent) and atrial fibrillation (five
percent); AEs led to discontinuation of IMBRUVICA® in
135 patients (35 percent), most commonly atrial fibrillation (five
percent) and fatigue (three percent). In the CIT cohort (n=363),
serious AEs occurred in 85 patients (23 percent), most commonly
febrile neutropenia (four percent) and pneumonia (three percent).
AEs led to discontinuation of CIT in 61 patients (17 percent), and
no single AE term led to discontinuation in three percent or more
of patients (most common was anemia, two
percent).5 The spectrum and frequency of AEs
observed with first-line treatment appeared consistent with data
from clinical studies and other RWE studies.5
is a once-daily oral medication that is jointly developed and
commercialized by Janssen Biotech, Inc. and Pharmacyclics LLC, an
AbbVie company. IMBRUVICA® blocks the Bruton's
tyrosine kinase (BTK) protein, which is needed by normal and
abnormal B cells, including specific cancer cells, to multiply and
spread. By blocking BTK, IMBRUVICA® may help move
abnormal B cells out of their nourishing environments and inhibits
IMBRUVICA® is approved in more than 100
countries and has been used to treat more than 270,000 patients
worldwide. There are more than 50 company-sponsored clinical
trials, including 18 Phase 3 studies, over 11 years evaluating the
efficacy and safety of IMBRUVICA®.
IMBRUVICA® was first approved by the U.S. Food
and Drug Administration (FDA) in November 2013, and today is
indicated for adult patients in six disease areas, including five
hematologic cancers. These include indications to treat adults with
CLL/SLL with or without 17p deletion (del17p), adults with
Waldenström's macroglobulinemia (WM), adults with previously
treated mantle cell lymphoma (MCL)*, adult patients with previously
treated marginal zone lymphoma (MZL) who require systemic therapy
and have received at least one prior anti-CD20-based therapy*, as
well as adult and pediatric patients one year of age and older with
previously treated chronic graft versus host disease (cGVHD) after
failure of one or more lines of systemic therapy.9
*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
For more information, visit www.IMBRUVICA.com.
IMPORTANT SIDE EFFECT INFORMATION
Before taking IMBRUVICA®, tell your
healthcare provider about all of your medical conditions, including
- 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
- Females who are able to become pregnant should use
effective birth control (contraception) during treatment with
IMBRUVICA® and for 1 month after the last dose.
- Males with female partners who are able to become
pregnant should use effective birth control, such as condoms,
during treatment with IMBRUVICA® and for 1 month after
the last dose.
- are breastfeeding or plan to breastfeed. Do not breastfeed
during treatment with IMBRUVICA® and for 1 week after
the last dose.
Tell your healthcare provider about all the medicines you
take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements. Taking
IMBRUVICA® with certain other medicines may affect how
IMBRUVICA® works and can cause side effects.
How should I take IMBRUVICA®?
- Take IMBRUVICA® exactly as your healthcare provider
tells you to take it.
- Take IMBRUVICA® 1 time a day at about the same time
IMBRUVICA® comes as capsules, tablets, and oral
- If your healthcare provider prescribes IMBRUVICA®
capsules or tablets:
- Swallow IMBRUVICA® capsules or tablets whole with a
glass of water.
- Do not open, break, or chew IMBRUVICA®
- Do not cut, crush, or chew IMBRUVICA® tablets.
- If your healthcare provider prescribes IMBRUVICA®
- See the detailed Instructions for Use that comes with
IMBRUVICA® oral suspension for information about the
correct way to give a dose to your child. If you have questions
about how to give IMBRUVICA® oral suspension, talk to
your healthcare provider.
- Do not use if the carton seal is broken or missing.
- If you miss a dose of IMBRUVICA® take it as soon as
you remember on the same day. Take your next dose of
IMBRUVICA® at your regular time on the next day. Do not
take extra doses of IMBRUVICA® to make up for a missed
- If you take too much IMBRUVICA® call your healthcare
provider or go to the nearest hospital emergency room right
What should I avoid while taking
- 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
What are the possible side effects of
cause serious side effects, including:
- Bleeding problems (hemorrhage) are common
during treatment with IMBRUVICA®, and can also be
serious and may lead to death. Your risk of bleeding may increase
if you are also taking a blood thinner medicine. Tell your
healthcare provider if you have any signs of bleeding, including:
blood in your stools or black stools (looks like tar), pink or
brown urine, unexpected bleeding, or bleeding that is severe or
that you cannot control, vomit blood or vomit looks like coffee
grounds, cough up blood or blood clots, increased bruising,
dizziness, weakness, confusion, change in your speech, or a
headache that lasts a long time or severe headache.
- Infections can happen during treatment with
IMBRUVICA®. These infections can be serious and may lead
to death. Tell your healthcare provider right away if you have
fever, chills, weakness, confusion, or other signs or symptoms of
an infection during treatment with IMBRUVICA®.
- Heart problems. Serious heart rhythm problems
(ventricular arrhythmias, atrial fibrillation and atrial flutter),
heart failure and death have happened in people treated with
IMBRUVICA®, especially in people who have an infection,
an increased risk for heart disease, or have had heart rhythm
problems in the past. Your heart function will be checked before
and during treatment with IMBRUVICA®. Tell your
healthcare provider if you get any symptoms of heart problems, such
as feeling as if your heart is beating fast and irregular,
lightheadedness, dizziness, shortness of breath, swelling of the
feet, ankles or legs, chest discomfort, or you faint. If you
develop any of these symptoms, your healthcare provider may do
tests to check your heart and may change your IMBRUVICA®
- 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
- 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
- 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:
muscle and bone pain
The most common side effects of
IMBRUVICA® in adults or children 1 year of
age and older with cGVHD include:
low red blood cell count
low platelet count
muscle and joint pain
mouth sores (stomatitis)
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
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
General information about the safe and effective use of
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
Please click here for full Prescribing Information.
is a first-in-class medicine that selectively binds and inhibits
the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2
prevents cancer cells from undergoing their natural death or
self-destruction process, called apoptosis. VENCLYXTA targets
the BCL-2 protein and works to help restore the process of
VENCLYXTA is being developed by AbbVie and Roche. It is
jointly commercialized by AbbVie and Genentech, a member of the
Roche Group, in the U.S. and by AbbVie outside of the U.S.
Together, the companies are committed to BCL-2 research and to
studying venetoclax in clinical trials across several blood and
other cancers. Venetoclax is approved in more than 80 countries,
including the U.S.
Approved Uses of VENCLEXTA
VENCLEXTA is a prescription medicine used:
- to treat adults with chronic lymphocytic leukemia (CLL) or
small lymphocytic lymphoma (SLL).
- in combination with azacitidine, or decitabine, or low-dose
cytarabine to treat adults with
newly diagnosed acute myeloid leukemia (AML) who:
- are 75 years of age or older, or
- have other medical conditions that prevent the use of standard
It is not known if VENCLEXTA is safe and effective in
Important Safety Information
What is the most important information I should know about
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
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
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
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
- are scheduled to receive a vaccine. You should not receive a
"live vaccine" before, during, or after treatment with VENCLEXTA,
until your healthcare provider tells you it is okay. If you are not
sure about the type of immunization or vaccine, ask your healthcare
provider. These vaccines may not be safe or may not work as well
during treatment with VENCLEXTA.
- are pregnant or plan to become pregnant. VENCLEXTA may harm
your unborn baby. If you are able to become pregnant, your
healthcare provider should do a pregnancy test before you start
treatment with VENCLEXTA, and you should use effective birth
control during treatment and for 30 days after the last dose of
VENCLEXTA. If you become pregnant or think you are pregnant, tell
your healthcare provider right away.
- are breastfeeding or plan to breastfeed. It is not known if
VENCLEXTA passes into your breast milk.
Do not breastfeed during treatment with VENCLEXTA and for 1 week
after the last dose.
What should I avoid while taking VENCLEXTA?
You should not drink grapefruit juice or eat
grapefruit, Seville oranges (often used in marmalades),
or starfruit while you are taking VENCLEXTA. These products may
increase the amount of VENCLEXTA in your blood.
What are the possible side effects of VENCLEXTA?
VENCLEXTA can cause serious side effects, including:
- Low white blood cell counts (neutropenia). Low
white blood cell counts are common with VENCLEXTA, but can also be
severe. Your healthcare provider will do blood tests to check your
blood counts during treatment with VENCLEXTA and may pause
- 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
If you cannot afford your medication,
contact genentech-access.com/patient/brands/venclexta for
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
https://www.abbvie.com/oncology and our Blood Cancer Press kit
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
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information about AbbVie, please visit us at www.abbvie.com.
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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.
IMBRUVICA® is a registered trademark of Pharmacyclics
1 Allen J.,
et al. Treatment Outcomes After Undetectable MRD With First-Line
Ibrutinib (Ibr) Plus Venetoclax (Ven): Fixed Duration Treatment
(Placebo) Versus Continued Ibr With Up to 5 Years Median Follow-up
in the CAPTIVATE Study. 2022 American Society of Hematology (ASH)
Annual Meeting. December 11, 2022.
C., et al. Residual Disease Kinetics Among Patients with High-Risk
Factors Treated with First-Line Fixed-Duration Ibrutinib plus
Venetoclax (Ibr+Ven) versus Chlorambucil plus Obinutuzumab (Clb+O):
the GLOW Study. 2022 American Society of Hematology Annual Meeting.
December 11, 2022.
3 Jacobs R.,
et. al. Real-World Comparison of Time to Next Treatment for
Patients with CLL Initiated on First-line Treatment with Ibrutinib
versus Acalabrutinib. American Society of Hematology Congress
4 Ghia P.,
et. al. Initiating First-Line (1L) Ibrutinib (Ibr) in Patients
(pts) with Chronic Lymphocytic Leukemia (CLL) Improves Overall
Survival (OS) Outcomes to Rates Approximating an Age-Matched
Population of ≥65 Years. American Society of Hematology Congress
5 Ghosh N.,
et. al. Real-World Outcomes With First-Line Ibrutinib (Ibr) Versus
Chemoimmunotherapy (CIT) in Patients With Chronic Lymphocytic
Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL): Final Analysis
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