NORTH CHICAGO, Ill.,
May 17, 2017 /PRNewswire/ -- AbbVie
(NYSE: ABBV), a global biopharmaceutical company, today announced
it will present data about the company's portfolio of approved and
investigational oncology medicines during the 53rd
Annual Meeting of the American Society of Clinical Oncology (ASCO),
June 2-6, in Chicago. A total of 23 abstracts have been
accepted across several tumor types including brain cancer,
hematologic malignancies, breast cancer, lung cancer and other
solid tumors.
Researchers will present efficacy and safety data on
depatuxizumab mafodotin (previously known as ABT-414), an
antibody-drug conjugate (ADC) being studied for the treatment of
adults with amplified-epidermal growth factor receptor (EGFR) newly
diagnosed or recurrent glioblastoma (GBM). GBM is one of the most
aggressive cancers, with a five-year survival rate of approximately
6 percent in the U.S. and 24 European countries.1,2 The
most common genetic alteration in GBM, EGFR-amplification, occurs
in approximately 50 percent of GBM patients.3,4
Additionally, researchers will present data from studies
evaluating venetoclax, a BCL-2 inhibitor developed by AbbVie and
Genentech, a member of the Roche Group, for investigational uses
across multiple hematologic malignancies; ibrutinib, an inhibitor
of Bruton's tyrosine kinase (BTK), across multiple hematologic
malignancies and chronic graft versus host disease (cGVHD);
rovalpituzumab tesirine (Rova-T), an investigational ADC targeting
delta-like protein 3 (DLL3)-expressing tumors in small cell lung
cancer (SCLC); veliparib, an investigational oral poly (adenosine
diphosphate [ADP]–ribose) polymerase (PARP) inhibitor, across
multiple solid tumors; elotuzumab, an immunostimulatory antibody
that specifically targets Signaling Lymphocyte Activation Molecule
Family member 7 (SLAMF7), a cell-surface glycoprotein; and other
early-stage investigational compounds.
AbbVie will also share early-stage research from its oncology
pipeline. AbbVie is utilizing technologies and new approaches to
help advance cancer therapies that may become foundational to the
next generation of cancer treatments.
"AbbVie's data presentations at this year's ASCO meeting
reinforce our diverse and comprehensive oncology pipeline, focused
on bringing new medicines to patients, especially in areas where
few options exist in cancer," said Tom
Hudson, M.D., vice president of oncology discovery and early
development, AbbVie. "By combining our deep knowledge in core areas
of biology with cutting-edge technologies, and working together
with our partners including scientists, industry peers and
patients, we aim to discover and develop medicines that will drive
transformational improvements in cancer treatment."
AbbVie abstracts:
Ibrutinib
- Long-Term Efficacy and Safety with Ibrutinib (ibr) in
Previously Treated Chronic Lymphocytic Leukemia (CLL): Up to Four
Years Follow-Up of the RESONATE Study; Byrd et al.;
Abstract 7510; Poster Discussion Presentation; Monday, June 5, 2017; Poster 8:00 a.m.-11:30 a.m. CDT; Discussion 1:15 p.m.-2:30 p.m. CDT
- Ibrutinib vs Chlorambucil: Immunophenotypic and Quantitative
Impacts on Circulating Immune Cells in Chronic Lymphocytic Leukemia
(CLL); Solman et al.; Abstract 7524; Poster
Presentation; Monday, June 5, 2017;
8:00 a.m.-11:30 a.m. CDT
- A Randomized, Double-Blind Phase III Study of Ibrutinib
versus Placebo in Combination with Corticosteroids in Patients with
New Onset Chronic Graft Versus Host Disease; Miklos et
al.; Abstract TPS7072; Poster Presentation; Monday, June 5, 2017; 8:00
a.m.-11:30 a.m. CDT
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled
Phase III Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor,
Ibrutinib, in Combination with Rituximab Versus Placebo in
Combination with Rituximab in Patients with Treatment-Naïve
Follicular Lymphoma (PERSPECTIVE); Fowler et al.;
Abstract TPS7576; Poster Presentation; Monday, June 5, 2017; 8:00
a.m.- 11:30 a.m. CDT
Venetoclax
- Phase 3, Randomized, Double-Blind, Placebo-Controlled Study
of Venetoclax Combined with Azacitidine Versus Azacitidine in
Treatment-Naïve Patients with Acute Myeloid Leukemia; Potluri et
al.; Abstract TPS7069; Poster Presentation; Monday, June 5, 2017; 8:00
a.m.-11:30 a.m. CDT
- Phase 2, Open-Label Study of Venetoclax in Combination with
Carfilzomib and Dexamethasone in Patients with Relapsed/Refractory
Multiple Myeloma; Bueno et al.; Abstract TPS8056; Poster
Presentation; Monday, June 5, 2017;
8:00 a.m.-11:30 a.m. CDT
- Venetoclax (VEN) in Patients with Relapsed Non-Hodgkin
Lymphoma (NHL); Davids et al.; Publication
Depatuxizumab mafodotin (ABT-414)
- Efficacy Analysis of ABT-414 with or without Temozolomide
(TMZ) in Patients (pts) with EGFR-Amplified, Recurrent Glioblastoma
(rGBM) from a Multicenter, International Phase I Clinical Trial;
van den Bent et al.;
Abstract 2003; Oral Presentation; Sunday,
June 4, 2017; 9:00 a.m.-9:12 a.m.
CDT
Rovalpituzumab tesirine (Rova-T)
- A Phase III Study of Rovalpituzumab Tesirine Maintenance
Therapy Following First-Line Platinum-Based Chemotherapy in
Patients with Extensive Disease Small Cell Lung Cancer (ED SCLC);
Komarnitsky et al.; Abstract TPS8583; Poster
Presentation; Saturday, June 3, 2017;
8:00 a.m.-11:30 a.m. CDT
- Molecular Profiling of Small Cell Bladder Cancer (SCBC) to
Reveal Gene Expression Determinants of Aggressive Phenotype;
Koshkin et al.; Abstract 4529; Poster Presentation;
Sunday, June 4, 2017; 8:00 a.m.-11:30 a.m. CDT
- A Study of Rovalpituzumab Tesirine in Frontline Treatment of
Patients with DLL3 Expressing Extensive Small Cell Lung Cancer;
Hann et al.; Abstract TPS2598; Poster Presentation;
Monday, June 5, 2017; 8:00 a.m.-11:30 a.m. CDT
- An Open-Label Study of Rovalpituzumab Tesirine in Patients
with DLL3-Expressing Advanced Solid Tumors; Kavalerchik et
al.; Abstract TPS2597; Poster Presentation; Monday, June 5, 2017; 8:00
a.m.-11:30 a.m. CDT
- Rovalpituzumab Tesirine (Rova-T) as a Therapeutic Agent for
Neuroendocrine Prostate Cancer (NEPC); Puca et al.; Abstract
5029; Poster Presentation; Monday, June 5,
2017; 1:15 p.m.-4:45 p.m.
CDT
Veliparib
- Phase 1/2 Study of Veliparib (V) Combined with Carboplatin
(Cb) and Etoposide (E) in Patients (Pts) with Extensive-Stage
Disease (ED) Small Cell Lung Cancer (SCLC) and Other Solid Tumors:
Phase 1 Results; Atrafi et al.; Abstract 8530; Poster
Presentation; Saturday, June 3, 2017;
8:00 a.m.-11:30 a.m. CDT
- Tolerability of Veliparib (V) in Combination with
Carboplatin (C)/Paclitaxel (P): Based Chemoradiotherapy (CRT) in
Subjects with Stage III Non-Small Cell Lung Cancer (NSCLC); Kozono
et al.; Abstract 8546; Poster Presentation; Saturday, June 3,
2017; 8:00 a.m.-11:30 a.m. CDT
- Breast Conservation after Neoadjuvant Chemotherapy for
Triple-Negative Breast Cancer: Surgical Results from an
International Randomized Trial (BrighTNess); Golshan et al.;
Abstract 514; Poster Discussion Presentation; Sunday, June 4, 2017; Poster 8:00 a.m.-11:30 a.m. CDT; Discussion 11:30 a.m.-12:45 p.m. CDT
- Phase 3 Study Evaluating Efficacy and Safety of Veliparib
(V) Plus Carboplatin (Cb) or Cb in Combination with Standard
Neoadjuvant Chemotherapy (NAC) in Patients (Pts) with Early Stage
Triple-Negative Breast Cancer (TNBC); Geyer et al.; Abstract
520; Poster Discussion Presentation; Sunday,
June 4, 2017; Poster 8:00 a.m.-11:30
a.m. CDT; Discussion 11:30 a.m.-12:45
p.m. CDT
Elotuzumab
- Phase 3 ELOQUENT-2 Study: Extended Four Year Follow-Up (FU)
of Elotuzumab Plus Lenalidomide/Dexamethasone (ELd) vs Ld in
Relapsed/Refractory Multiple Myeloma (RRMM); Lonial et al.;
Abstract 8028; Poster Presentation; Monday,
June 5, 2017; 8:00 a.m.-11:30 a.m.
CDT
- CheckMate 602: An Open-Label, Randomized, Phase 3 Trial of
Combinations of Nivolumab, Elotuzumab, Pomalidomide and
Dexamethasone in Relapsed/Refractory Multiple Myeloma; Lonial et
al.; Abstract TPS8052; Poster Presentation; Monday, June 5, 2017; 8:00
a.m.-11:30 a.m. CDT
ABBV-221
- Preliminary Results from a Phase 1 Study of the
Antibody-Drug Conjugate ABBV-221 in Patients with Solid Tumors
Likely to Express EGFR; Calvo et al.; Abstract 2510;
Poster Discussion Presentation; Monday, June
5, 2017; Poster 8:00 a.m.-11:30 a.m.
CDT; Discussion 11:30 a.m.-12:45 p.m.
CDT
ABBV-399
- Phase I Study of ABBV-399, a c-Met Antibody-Drug Conjugate
(ADC), as Monotherapy and in Combination with Erlotinib in Patients
(Pts) with Non-Small Cell Lung Cancer (NSCLC); Angevin et al.;
Abstract 2509; Poster Discussion Presentation; Monday, June 5, 2017; Poster 8:00 a.m.-11:30 a.m. CDT; Discussion 11:30 a.m.-12:45 p.m. CDT
- Impact of MET Inhibitors on Survival Among Patients (Pts)
with MET Exon 14 Mutant (METdel14) Non-Small Cell Lung Cancer
(NSCLC); Awad et al.; Abstract 8511; Clinical Science
Symposium; Sunday, June 4, 2017;
8:00 a.m.-9:30 a.m. CDT
ABT-348
- Pharmaco-kinetics/dynamics (PK/PD) Evaluation and Individual
Patient Cross-Over Studies with Growth Trajectory Assessment to
Adaptively Develop Ilorasertib; Maitland et al.; Abstract 2563;
Poster Presentation; Monday, June 5,
2017; 8:00 a.m.-11:30 a.m.
CDT
The ASCO 2017 Annual Meeting abstracts are available at
http://am.asco.org/abstracts.
About IMBRUVICA® (ibrutinib) in the U.S.
IMBRUVICA is a first-in-class, oral, once-daily therapy that
inhibits 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.5,6 IMBRUVICA blocks signals that
tell malignant B cells to multiply and spread
uncontrollably.5
IMBRUVICA is FDA-approved in five distinct patient populations:
CLL, SLL, WM, along with previously-treated MCL and MZL.
- IMBRUVICA was first approved for patients with MCL who have
received at least one prior therapy in November 2013.
- Soon after, IMBRUVICA was initially approved in CLL patients
who have received at least one prior therapy in February 2014. By July
2014, the therapy received approval for CLL patients with
17p deletion, and by March 2016, the
therapy was approved as a frontline CLL treatment.
- IMBRUVICA was approved for patients with WM in January 2015.
- In May 2016, IMBRUVICA was
approved in combination with bendamustine and rituximab (BR) for
patients with previously treated CLL/SLL.
- In January 2017, IMBRUVICA was
approved for patients with MZL who require systemic therapy and
have received at least one prior anti-CD20-based therapy.
Accelerated approval was granted for the MCL and MZL indication
based on overall response rate. Continued approval for MCL and MZL
may be contingent upon verification and description of clinical
benefit in confirmatory trials.5
IMBRUVICA was one of the first medicines to receive U.S. Food
and Drug Administration (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 nearly 30 company-sponsored trials underway, 14 of which are
in Phase 3. In addition, there are approximately 100
investigator-sponsored trials and external collaborations that are
ongoing and active around the world. To date, more than 65,000
patients around the world have been treated with IMBRUVICA in
clinical practice and clinical trials.
Patient Access to IMBRUVICA
AbbVie and Janssen strive to make access to IMBRUVICA easy by
helping patients in the U.S. understand their insurance benefits
for IMBRUVICA. The YOU&i™ Support Program is a program that
includes information on access and affordability support options,
nurse call support and resources for patients being treated with
IMBRUVICA.
IMBRUVICA® (ibrutinib) U.S. 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 up to 6% of patients.
Bleeding events of any grade, including bruising and petechiae,
occurred in approximately half 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 postsurgery depending upon the type of surgery and
the risk of bleeding.
Infections - Fatal and nonfatal infections have occurred
with IMBRUVICA® therapy. Grade 3 or greater infections
occurred in 14% to 29% of patients. Cases of progressive multifocal
leukoencephalopathy (PML) and Pneumocystis jirovecii pneumonia
(PJP) have occurred in patients treated with IMBRUVICA®.
Evaluate patients for fever and infections and treat
appropriately.
Cytopenias - Treatment-emergent Grade 3 or 4 cytopenias
including neutropenia (range, 13% to 29%), thrombocytopenia (range,
5% to 17%), and anemia (range, 0% to 13%) based on laboratory
measurements occurred in patients treated with single agent
IMBRUVICA®. Monitor complete blood counts monthly.
Atrial Fibrillation - Atrial fibrillation and atrial
flutter (range, 6% to 9%) have occurred in patients treated with
IMBRUVICA®, particularly in patients with cardiac risk
factors, hypertension, acute infections, and a previous history of
atrial fibrillation. Periodically monitor patients clinically for
atrial fibrillation. Patients who develop arrhythmic symptoms (eg,
palpitations, lightheadedness) or new-onset dyspnea should have an
ECG performed. Atrial fibrillation should be managed appropriately
and if it persists, consider the risks and benefits of
IMBRUVICA® treatment and follow dose modification
guidelines.
Hypertension - Hypertension (range, 6% to 17%) has
occurred in patients treated with IMBRUVICA® with a
median time to onset of 4.6 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 antihypertensive medications and/or initiate
antihypertensive treatment as appropriate.
Second Primary Malignancies - Other malignancies (range,
3% to 16%) including non-skin carcinomas (range, 1% to 4%) have
occurred in patients treated with IMBRUVICA®. The most
frequent second primary malignancy was non-melanoma skin cancer
(range, 2% to 13%).
Tumor Lysis Syndrome - Tumor lysis syndrome has been
infrequently reported with IMBRUVICA® therapy. Assess
the baseline risk (eg, 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
The most common adverse reactions (≥20%) in patients with B-cell
malignancies (MCL, CLL/SLL, WM and MZL) were neutropenia* (61%),
thrombocytopenia* (62%), diarrhea (43%), anemia* (41%),
musculoskeletal pain (30%), rash (30%), nausea (29%), bruising
(30%), fatigue (29%), hemorrhage (22%), and pyrexia (21%).
* Based on adverse reactions and/or laboratory measurements
(noted as platelets, neutrophils, or hemoglobin decreased).
The most common Grade 3 or 4 non-hematologic adverse reactions
(≥5%) in MCL patients were pneumonia (7%), abdominal pain (5%),
atrial fibrillation (5%), diarrhea (5%), fatigue (5%), and skin
infections (5%). The most common Grade 3 or 4 non-hematologic
adverse reactions (≥5%) in MZL patients were pneumonia (10%),
fatigue (6%), diarrhea (5%), rash (5%), and hypertension (5%).
Approximately 6% (CLL/SLL), 14% (MCL), 11% (WM) and 10% (MZL) of
patients had a dose reduction due to adverse reactions.
Approximately 4%-10% (CLL/SLL), 9% (MCL), and 9% (WM [6%] and MZL
[13%]) of patients discontinued due to adverse reactions. Most
common adverse reactions leading to discontinuation were pneumonia,
hemorrhage, atrial fibrillation, rash, and neutropenia (1% each) in
CLL/SLL patients and subdural hematoma (1.8%) in MCL patients. The
most common adverse reactions leading to discontinuation were
interstitial lung disease, diarrhea, and rash (1.6% each) in WM and
MZL patients.
DRUG INTERACTIONS
CYP3A Inhibitors - Avoid coadministration with strong and
moderate CYP3A inhibitors. If a moderate CYP3A inhibitor must be
used, reduce the IMBRUVICA® dose.
CYP3A Inducers - Avoid coadministration with strong CYP3A
inducers.
SPECIFIC POPULATIONS
Hepatic Impairment - Avoid use in patients with moderate
or severe baseline hepatic impairment. In patients with mild
impairment, reduce IMBRUVICA® dose.
Please see Full Prescribing Information:
https://www.imbruvica.com/prescribing-information.
About VENCLEXTA™ (venetoclax) in the U.S.
Venclexta (venetoclax) is an oral B-cell lymphoma-2 (BCL-2)
inhibitor developed by AbbVie and Genentech, a member of the Roche
Group, indicated in the U.S. for the treatment of patients with
relapsed/refractory chronic lymphocytic leukemia (CLL) with 17p
deletion, as detected by an FDA-approved test. This indication
is approved under accelerated approval based on overall response
rate. Continued approval for this indication may be contingent upon
verification and description of clinical benefit in a confirmatory
trial.
There is an ongoing study to find out how Venclexta works over a
longer period of time. It is not known if Venclexta is safe and
effective in children.
Venclexta targets a specific protein in the body called BCL-2.
When you have CLL, BCL-2 may build up and prevent cancer cells from
self-destructing naturally. Venclexta targets BCL-2 in order to
help restore the process of apoptosis. Through apoptosis, your body
allows cancer cells and normal cells to self-destruct.
AbbVie and Genentech are committed to BCL-2 research with
venetoclax, which is currently being evaluated in Phase 3 clinical
trials for the treatment of relapsed/refractory and first-line CLL,
along with early phase studies in several cancers.
Venetoclax is under evaluation by health authorities in multiple
countries, and is currently approved in more than 10 nations,
including the U.S.
The full U.S. prescribing information for Venclexta can be
found here.
Patient Assistance Program
For those who qualify, AbbVie and Genentech offer patient
assistance programs for people taking Venclexta in the U.S.
VENCLEXTA™ (venetoclax) U.S. Use and Important Safety
Information
Use
What is VENCLEXTA™ (venetoclax)?
VENCLEXTA™ (venetoclax) is a prescription medicine used to treat
people with chronic lymphocytic leukemia (CLL) with 17p deletion
who have received at least one prior treatment.
VENCLEXTA was approved based on response rate. There is an
ongoing study to find out how VENCLEXTA works over a longer period
of time.
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 doctor will do
tests for TLS. It is important to keep your appointments for blood
tests. 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. Tell
your doctor 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.
- Tell your doctor 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 doctor.
What should I tell my doctor before taking VENCLEXTA?
Before taking VENCLEXTA, tell your doctor 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 doctor tells you it is okay. If you are not sure about
the type of immunization or vaccine, ask your doctor. 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 doctor
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.
- 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 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 count (neutropenia). Low white
blood cell counts are common with VENCLEXTA, but can also be
severe. Your doctor will do blood tests to check your blood counts
during treatment with VENCLEXTA. Tell your doctor right away if you
have a fever or any signs of an infection.
The most common side effects of VENCLEXTA include low
white blood cell count, diarrhea, nausea, low red blood cell count,
upper respiratory tract infection, low platelet count, and feeling
tired.
VENCLEXTA may cause fertility problems in males. This may affect
your ability to father a child. Talk to your doctor if you have
concerns about fertility.
These are not all the possible side effects of VENCLEXTA. Tell
your doctor if you have any side effect that bothers you or that
does not go away.
About Empliciti™ (elotuzumab) in the U.S.
Empliciti is an immunostimulatory antibody that specifically
targets Signaling Lymphocyte Activation Molecule Family member 7
(SLAMF7), a cell-surface glycoprotein. SLAMF7 is expressed on
myeloma cells independent of cytogenetic abnormalities. SLAMF7 is
also expressed on Natural Killer cells, plasma cells and at lower
levels on specific immune cell subsets of differentiated cells
within the hematopoietic lineage.7
Empliciti has a dual mechanism-of-action. It directly activates
the immune system through Natural Killer cells via the SLAMF7
pathway. Empliciti also targets SLAMF7 on myeloma cells, tagging
these malignant cells for Natural Killer cell-mediated destruction
via antibody-dependent cellular toxicity.
On November 30, 2015, the U.S.
Food and Drug Administration (FDA) approved Empliciti in
combination with lenalidomide and dexamethasone in patients with
multiple myeloma who have received one to three prior therapies.
The safety and efficacy of Empliciti is still being evaluated by
other health authorities. Bristol-Myers
Squibb and AbbVie are co-developing Empliciti, with
Bristol-Myers Squibb solely responsible for commercial
activities.
EMPLICITI™ (elotuzumab) U.S. IMPORTANT SAFETY
INFORMATION
WHAT IS EMPLICITI?
EMPLICITI™ (elotuzumab) is a prescription medicine used to treat
multiple myeloma in combination with the medicines
REVLIMID® (lenalidomide) and dexamethasone in people who
have received one to three prior treatments for their multiple
myeloma.
It is not known if EMPLICITI is safe and effective in
children.
IMPORTANT SAFETY INFORMATION
EMPLICITI is used in combination with REVLIMID and
dexamethasone. It is important to remember that the safety
information for these medications also applies to EMPLICITI
combination therapy.
Before you receive EMPLICITI, tell your healthcare provider
about all of your medical conditions, including if you:
- have an infection
- are pregnant or plan to become pregnant. It is not known if
EMPLICITI may harm your unborn baby. However, REVLIMID may cause
birth defects or death of an unborn baby.
-
- Before receiving EMPLICITI with REVLIMID and dexamethasone,
females and males must agree to the instructions in the REVLIMID
REMS® program. This program has specific requirements
about birth control (contraception), pregnancy testing, blood
donation, and sperm donation that you need to know. Talk to your
healthcare provider to learn more about REVLIMID.
- are breastfeeding or plan to breastfeed. It is not known if
EMPLICITI passes into breast milk. You should not breastfeed during
treatment with EMPLICITI and REVLIMID and dexamethasone.
- Tell your healthcare provider about all the medicines you
take, including prescription and over-the-counter medicines,
vitamins, and herbal supplements.
Serious side effects that can occur with EMPLICITI treatment
are:
Infusion reactions
- Infusion reactions can happen during your infusion or within 24
hours after your infusion of EMPLICITI. Your healthcare provider
will give you medicines before each infusion of EMPLICITI to help
reduce the risk of an infusion reaction.
- If you have an infusion reaction while receiving EMPLICITI,
your healthcare provider will slow or stop your infusion and treat
your reaction. If you have a severe infusion reaction your
healthcare provider may stop your treatment completely.
- Tell your healthcare provider or get medical help right away if
you have any of these symptoms after your infusion with EMPLICITI:
fever, chills, rash, trouble breathing, dizziness,
light-headedness.
Infections
- Those receiving EMPLICITI with REVLIMID and dexamethasone may
develop infections; some can be serious.
- Tell your healthcare provider right away if you have any of the
signs and symptoms of an infection, including: fever, flu-like
symptoms, cough, shortness of breath, burning with urination, or a
painful skin rash.
Risk of new cancers (malignancies)
- Those receiving EMPLICITI with REVLIMID and dexamethasone have
a risk of developing new cancers.
- Talk with your healthcare provider about your risk of
developing new cancers if you receive EMPLICITI.
- Your healthcare provider will check you for new cancers during
your treatment with EMPLICITI.
Liver problems
- EMPLICITI may cause liver problems. Your healthcare provider
will do blood tests to check your liver during treatment with
EMPLICITI.
- Tell your healthcare provider if you have signs and symptoms of
liver problems, including: tiredness, weakness, loss of appetite,
yellowing of your skin or eyes, color changes in your stools,
confusion, or swelling of the stomach area.
The most common side effects of EMPLICITI include:
• fatigue
|
• numbness, weakness, tingling, or burning
pain in your arms or legs
|
• diarrhea
|
• sore throat or runny nose
|
• fever
|
• upper respiratory tract infection
|
• constipation
|
• decreased appetite
|
• cough
|
• pneumonia
|
These are not all of the possible side effects of EMPLICITI.
Call your doctor for medical advice about side effects. You may
report side effects to FDA at 1-800-FDA-1088.
Please read Patient Information in the full Prescribing
Information.
About Depatuxizumab Mafodotin
Depatuxizumab mafodotin, previously known as ABT-414, is an
investigational antibody-drug-conjugate (ADC) being developed by
AbbVie researchers with components in-licensed from Life Science
Pharmaceuticals, Inc. and Seattle Genetics.8
Depatuxizumab mafodotin is a biomarker-driven therapy that binds to
an epitope that is exposed on tumor cells with epidermal growth
factor receptor (EGFR) amplification and delivers a potent
cytotoxin, a substance toxic to cells, that is released inside the
tumor cell. It is being evaluated for EGFR-amplified newly
diagnosed or recurrent glioblastoma (GBM), an aggressive malignant
brain tumor.9
In 2014, the U.S. Food and Drug Administration (FDA) and the
European Commission (EC) granted depatuxizumab mafodotin Orphan
Drug Designation (ODD) for the treatment of GBM and glioma in
adults, respectively.10,11 In 2016, the FDA granted
depatuxizumab mafodotin Rare Pediatric Disease Designation for the
treatment of diffuse intrinsic pontine glioma (DIPG), a type of
pediatric brain tumor.12 Depatuxizumab mafodotin is an
investigational compound and its efficacy and safety have not been
established by the FDA or any other health authority.
About Rovalpituzumab Tesirine (Rova-T)
Rovalpituzumab tesirine (Rova-T) is an investigational
antibody-drug conjugate (ADC) targeting delta-like protein 3
(DLL3), which is expressed in about 80 percent of small cell lung
cancer (SCLC) patient tumors. It is prevalent on SCLC tumor cells,
but not present in healthy tissue.13 Rova-T combines a
targeted antibody with a cytotoxic agent to deliver a substance
toxic to cells directly to the DLL3-expressing cancer cells. Rova-T
is under investigation for the treatment of SCLC. An open-label,
single-arm Phase 2 trial is under way to evaluate Rova-T in the
third-line setting in relapsed or refractory DLL3-expressing
SCLC.14 Two randomized Phase 3 trials have been
initiated in the second-line and first-line maintenance setting.
Additional studies are underway in multiple neuroendocrine tumor
types, metastatic melanoma, and glioblastoma
(GBM).15
Rova-T is an investigational compound and its efficacy and
safety have not been established by the U.S. Food and Drug
Administration (FDA) or any other health authority.
About Veliparib
Veliparib is an investigational oral poly (adenosine diphosphate
[ADP]–ribose) polymerase (PARP) inhibitor being evaluated in
multiple tumor types.16,17 PARP is a
naturally-occurring enzyme in the body that repairs damage to DNA
in cells. While this repair is a useful process to maintain the
integrity of healthy cells, the same process may also help repair
DNA in cancer cells, causing them to survive.18
Discovered and developed by AbbVie researchers, veliparib is
being studied in combination with chemotherapy or radiation to help
determine whether it can improve the survival outcome of common
DNA-damaging therapies, such as chemotherapy or radiation, compared
to platinum chemotherapy regimens
alone.16 Veliparib is currently being studied in
more than a dozen cancers, including in Phase 3 studies in advanced
or metastatic non-squamous non-small cell lung cancer (NSCLC),
ovarian cancer and BRCA1/2 breast
cancer.19 Veliparib is an investigational medicine
and its efficacy and safety have not been established by the U.S.
Food and Drug Administration (FDA) or any other health
authority.
About ABBV-221, ABBV-399 and ABT-348
ABBV-221 is an investigational epidermal growth factor receptor
(EGFR)-targeted antibody-drug conjugate (ADC) being studied in an
open-label, dose escalation Phase 1 clinical trial for the
treatment of EGFR-expressing solid tumors in participants with
advanced solid tumors likely to exhibit elevated levels of
EGFR.20 ABBV-399 is an investigational c-Met targeted
ADC being studied in an open-label Phase 1 clinical trial
evaluating its safety, pharmacokinetics (PK) and preliminary
efficacy in patients with solid tumors.21,22 ABT-348 is
an investigational novel kinase inhibitor targeting the aurora,
vascular endothelial growth factor receptor/platelet-derived growth
factor receptor, and Src kinase families and is being studied in a
Phase 2 clinical trial of patients with CDKN2A deficient solid
tumors.23,24 These are investigational compounds and
their safety and efficacy have not been evaluated by the U.S. Food
and Drug Administration (FDA) or any other health authority.
About AbbVie in Oncology
AbbVie is striving to outsmart cancer by working with scientists,
physicians, industry peers, patient advocacy groups and most
importantly patients, to discover, develop and provide new
therapies that may have a remarkable impact on the lives of people
around the world affected by cancer. Our goal is to provide
medicines that make a transformational improvement in cancer
treatment and outcomes for cancer patients. By exploring and
investing in new pathways, technologies and approaches, AbbVie is
breaking ground in some of the most widespread and
difficult-to-treat cancers. We are also exploring solutions to help
patients obtain access to our cancer medicines. With the
acquisition of Pharmacyclics in 2015 and Stemcentrx in 2016, and
through several collaborations, AbbVie's oncology portfolio
consists of marketed medicines and a pipeline containing multiple
new molecules being evaluated worldwide in nearly 200 clinical
trials in 20 different tumor types. For more information about
AbbVie Oncology, please visit http://abbvieoncology.com.
About Pharmacyclics, An AbbVie Company
Pharmacyclics LLC, a wholly-owned subsidiary of AbbVie (NYSE:
ABBV), is focused on developing and commercializing innovative
small-molecule drugs for the treatment of cancer and
immune-mediated diseases. Pharmacyclics' mission is to develop and
commercialize novel therapies intended to improve quality of life,
increase duration of life and resolve serious unmet medical
needs.
Pharmacyclics markets IMBRUVICA and has two product candidates
in clinical development and several preclinical molecules in lead
optimization. Pharmacyclics is committed to high standards of
ethics, scientific rigor and operational efficiency as it moves
each of these programs toward commercialization. To learn more,
please visit www.pharmacyclics.com.
About AbbVie
AbbVie is a global, research-driven
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 or LinkedIn.
AbbVie Forward-Looking Statements
Some statements in this news release may be 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 2015 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.
References
1 Ostrom QT, et al. CBTRUS statistical report:
primary brain and other central nervous system tumors diagnosed in
the United States in 2009–2013.
Neuro Oncol. 2016;18:v1-v75.
2 Visser O, et al. Survival of adults with primary
malignant brain tumours in Europe;
Results of the EUROCARE-5 study. Eur J Cancer. 2015 [Epub
ahead of print].
3 Brennan CW, et al. The somatic genomic landscape of
glioblastoma. Cell. 2013;155:462-477.
4 Yoshimoto K, et al. Development of a real-time RT-PCR
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Clin Cancer Res.
2008;14:488-493.
5 IMBRUVICA US Prescribing Information, January 2017.
6 Genetics Home Reference (2017). Isolated growth
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http://ghr.nlm.nih.gov/condition/isolated-growth-hormone-deficiency.
Accessed March 2017.
7 Empliciti [Package Insert]. Princeton, N.J.: Bristol-Myers Squibb
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8 Van den Bent M, et al. ACTR-07. Efficacy of a novel
antibody-drug conjugate (ADC), ABT-414, as monotherapy in epidermal
growth factor receptor (EGFR) amplified, recurrent glioblastoma
(GBM). Neuro Oncol. 2016; 18.
9 Omuro A, et al. Glioblastoma and other malignant
gliomas: A clinical review. JAMA.
2013;310(17):1842-1850.
10 AbbVie Inc. ABT-414 Sponsor Briefing Document.
Pediatric Oncology Subcommittee. November
19, 2015.
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM472970.pdf.
Accessed March 2017.
11 U.S. Food and Drug Administration (2014). Orphan Drug
Designations and Approvals.
https://www.accessdata.fda.gov/scripts/opdlisting/oopd/OOPD_Results_2.cfm?Index_Number=433214.
Accessed March 2017.
12 Warren KE, et al. Diffuse intrinsic pontine glioma:
poised for progress. Front Oncol. 2012;2:205.
13 Saunders LR, et al. A DLL3-targeted antibody-drug
conjugate eradicates high-grade pulmonary neuroendocrine
tumor-initiating cells in vivo. Sci Transl Med.
2015;7(302):1-13.
14 ClinicalTrials.gov (2017). NCT02674568: Study of
Rovalpituzumab Tesirine (SC16LD6.5) for Third-line and Later
Treatment of Subjects With Relapsed or Refractory Delta-Like
Protein 3-Expressing Small Cell Lung Cancer (TRINITY).
https://clinicaltrials.gov/ct2/show/NCT02674568?term=NCT02674568&rank=1.
Accessed March 2017.
15 ClinicalTrials.gov (2017). Search Results:
Rovalpituzumab Tesirine.
https://clinicaltrials.gov/ct2/results?term=Rovalpituzumab+Tesirine+&Search=Search.
Accessed March 2017.
16 Palma JP, et al. ABT-888 confers broad in vivo
activity in combination with temozolomide in diverse tumors.
Clin Cancer Res.
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17 Anders CK, et al. Poly (ADP-Ribose) polymerase
inhibition: "targeted" therapy for triple-negative breast cancer.
Clin Cancer Res.
2010;16(19):4702-4710.
18 Plummer ER, et al. Targeting Poly (ADP-Ribose)
Polymerase: A Two-Armed Strategy for Cancer Therapy.
Clin Cancer Res. 2007;13(21):
6252-6256.
19 ClinicalTrials.gov (2017). Results: Veliparib: Open
Studies.
https://clinicaltrials.gov/ct2/results?term=veliparib&recr=Open.
Accessed March 2017.
20 Calvo, et al. Preliminary Results from a Phase 1
Study of the Antibody-Drug Conjugate ABBV-221 in Patients with
Solid Tumors Likely to Express EGFR. Abstract 2510; Poster
Discussion Presentation; Monday, June 5,
2017; Poster 8:00 a.m.-11:30 a.m.
CDT; Discussion 11:30 a.m.-12:45 p.m.
CDT.
21 Angevin, et al. Phase I Study of ABBV-399, a c-Met
Antibody-Drug Conjugate (ADC), as Monotherapy and in Combination
with Erlotinib in Patients (Pts) with Non-Small Cell Lung Cancer
(NSCLC). Abstract 2509; Poster Discussion Presentation;
Monday, June 5, 2017; Poster
8:00 a.m.-11:30 a.m. CDT; Discussion
11:30 a.m.-12:45 p.m. CDT.
22 Awad, et al. Impact of MET Inhibitors on Survival
Among Patients (Pts) with MET Exon 14 Mutant (METdel14) Non-Small
Cell Lung Cancer (NSCLC). Abstract 8511; Clinical Science
Symposium; Sunday, June 4, 2017;
8:00 a.m.-9:30 a.m. CDT.
23 Maitland, et al. Pharmaco-kinetics/dynamics (PK/PD)
Evaluation and Individual Patient Cross-Over Studies with Growth
Trajectory Assessment to Adaptively Develop Ilorasertib. Abstract
2563; Poster Presentation; Monday, June 5,
2017; 8:00 a.m.-11:30 a.m.
CDT.
24 ClinicalTrials.gov (2017). NCT02478320: Phase II
Study of Ilorasertib (ABT348) in Patients With CDKN2A Deficient
Solid Tumors. https://clinicaltrials.gov/ct2/show/NCT02478320.
Accessed May 2017.
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/abbvie-to-present-latest-clinical-study-results-in-hematology-and-solid-tumor-research-at-the-53rd-american-society-of-clinical-oncology-asco-annual-meeting-300459531.html
SOURCE AbbVie