SUNNYVALE, Calif., May 13, 2015 /PRNewswire/ -- Pharmacyclics,
Inc. (NASDAQ: PCYC) announced today that ibrutinib
(IMBRUVICA®) single-agent and combination data will be
featured in seven oral and poster sessions at the 51st
American Society of Clinical Oncology (ASCO) Annual Meeting being
held May 29-June 2, 2015 in
Chicago, IL. According to a
statement from ASCO, IMBRUVICA data will also be included in the
official press program during the meeting for the second time in
two years. IMBRUVICA is jointly developed and commercialized by
Pharmacyclics and Janssen Biotech, Inc.
Data being presented include, among others, an oral presentation
from the Phase III HELIOS (CLL3001, abstract #LBA7005) study of
ibrutinib in combination with bendamustine and rituximab in
relapsed or refractory chronic lymphocytic leukemia (CLL), a poster
presentation of ibrutinib in steroid-dependent or refractory
chronic graft-versus-host-disease (GVHD) (abstract #7024) as well
as a dose adherence analysis of ibrutinib 420 mg administered to
previously treated CLL patients (abstract #7012).
"We look forward to sharing promising data at this year's ASCO
that examines the use of IMBRUVICA across a broad range of
hematologic disease settings from our clinical studies," said
Danelle James, M.D., M.S., Head of
Oncology at Pharmacyclics. "Addressing difficult-to-treat
hematologic and solid malignancies remains a top priority for us
and our development program is designed to help establish IMBRUVICA
as a backbone of therapy across a broad range of histologies."
A list of accepted ibrutinib abstracts is included
below. The abstracts are also available on the ASCO
website.
Notable Presentations:
Oral
Presentation
First
Results from a Phase III Study of ibrutinib in Combination with
bendamustine and rituximab in Relapsed or Refractory Chronic
Lymphocytic Leukemia. (Abstract LBA7005)
Oral Abstract
Session: Leukemia, Myelodysplasia, and Transplantation.
Saturday, May 30 at 2:27 p.m. CDT in E Arie Crown
Theater.
Lead Author: Asher Alban
Chanan-Khan, M.D., The Mayo Clinic, Jacksonville, Florida, USA.
Poster Presentations
Dose Adherence and Baseline
Exposure Analysis of the ibrutinib 420 mg Dose Administered to
Patients with Previously Treated CLL. (Abstract 7012)
Poster Session: Leukemia, Myelodysplasia, and Transplantation.
Sunday, May 31 at 8:00 a.m. CDT in S Hall A.
Lead Author:
Paul M. Barr, M.D., Wilmot Cancer
Institute, University of Rochester,
Rochester, NY, USA.
A Multicenter Open-label Phase Ib/II Study of ibrutinib in
Steroid Dependent or Refractory Chronic Graft Versus Host Disease.
(Abstract 7024)
Poster Session: Leukemia, Myelodysplasia,
and Transplantation. Sunday, May 31
at 8:00 a.m. CDT in S Hall
A.
Lead Author: David Bernard
Miklos, M.D., Ph.D., Stanford
University Medical Center, Stanford, CA, USA.
Poster Presentations for Trials in Progress
A
Randomized, Double-blind, Placebo-controlled, Phase III Study of
rituximab with or without ibrutinib for Waldenstrom's
Macroglobulinemia. (Abstract TPS8599)
Poser
Session: Lymphoma and Plasma Cell Disorders. Sunday, May 31 at 8:00
a.m. CDT in S Hall A.
Lead Author: Meletios A. Dimopoulos, M.D., National and
Kapodistrian, University of Athens, Athens,
Greece.
A Phase III Study of ibrutinib in Combination with Either
bendamustine and rituximab (BR) or rituximab, cyclophosphamide,
doxorubicin, vincristine, and prednisone (R-CHOP) in Subjects with
Previously Treated Follicular Lymphoma or Marginal Zone Lymphoma.
(Abstract TPS8601)
Poser Session: Lymphoma and Plasma
Cell Disorders. Sunday, May 31 at
8:00 a.m. CDT in S Hall
A.
Lead Author: Nathan Hale
Fowler, M.D., The University of
Texas MD Anderson Cancer Center, Houston, Texas, USA.
Randomized, Multicenter, Open-label, Phase III Study of the
BTK inhibitor ibrutinib + obinutuzumab vs. chlorambucil +
obinutuzumab in Patients with Treatment-naïve CLL/SLL. (Abstract
TPS7095)
Poster Session: Leukemia, Myelodysplasia, and
Transplantation. Sunday, May 31 at
8:00 a.m. CDT in S Hall
A.
Lead Author: Ian Flinn,
M.D., Sarah Cannon Research Institute, Nashville, TN, USA.
A Multicenter, Open-label Phase IIa Study of ibrutinib with
or without Cytarabine in Patients with Acute Myeloid Leukemia.
(Abstract TPS7096)
Poster Session: Leukemia,
Myelodysplasia, and Transplantation. Sunday,
May 31 at 8:00 a.m. CDT in S
Hall A.
Lead Author: Jorge
Cortes, M.D., The University of
Texas MD Anderson Cancer Center, Houston, Texas, USA.
About IMBRUVICA
IMBRUVICA is currently approved
for the treatment of patients with chronic lymphocytic leukemia
(CLL) who have received at least one prior therapy, all CLL
patients (including treatment-naive) who have del 17p, a genetic
mutation that occurs when part of chromosome 17 has been lost, and
all patients (including treatment-naive) with Waldenström's
macroglobulinemia.1 IMBRUVICA is also approved under
accelerated approval for the treatment of patients with mantle cell
lymphoma (MCL) who have received at least one prior
therapy.1
IMBRUVICA (ibrutinib) is a first-in-class, oral, once-daily
therapy that inhibits a protein called Bruton's tyrosine kinase
(BTK).1 IMBRUVICA was one of the first medicines to
receive U.S. FDA approval via the new Breakthrough Therapy
Designation pathway, and is the only product to have received three
Breakthrough Therapy Designations.
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.1,2 IMBRUVICA blocks signals that tell
malignant B cells to multiply and spread
uncontrollably.1
IMBRUVICA is being studied alone and in combination with other
treatments in several blood cancers. More than 6,100 patients have
been treated in clinical trials of IMBRUVICA conducted in 35
countries by more than 800 investigators. Currently, 13 Phase III
trials have been initiated with IMBRUVICA and 62 trials are
registered on www.clinicaltrials.gov.
To learn more about the medical terminology used in this news
release, please visit
http://stedmansonline.com/.
INDICATIONS
IMBRUVICA is indicated to treat people with:
- Chronic lymphocytic leukemia (CLL) who have received at least
one prior therapy
- Chronic lymphocytic leukemia (CLL) with 17p deletion
- Waldenström's macroglobulinemia
- Mantle cell lymphoma (MCL) who have received at least one prior
therapy – accelerated approval was granted for this indication
based on overall response rate. Continued approval for this
indication may be contingent upon verification of clinical benefit
in confirmatory trials.
Patients taking IMBRUVICA for CLL or WM should take 420 mg taken
orally once daily (or three 140 mg capsules once daily).
Patients taking IMBRUVICA for MCL should take 560 mg taken
orally once daily (or four 140 mg capsules once daily).
Capsules should be taken orally with a glass of water. Capsules
should be taken whole. Do not open, break, split or chew the
capsules.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Hemorrhage - Fatal bleeding events have occurred in
patients treated with IMBRUVICA®. Grade 3
or higher bleeding events (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. Consider the benefit-risk of withholding
IMBRUVICA® for at least 3 to 7 days pre and
post-surgery depending upon the type of surgery and the risk of
bleeding.
Infections - Fatal and non-fatal infections have occurred
with IMBRUVICA® therapy. Grade 3 or greater
infections occurred in 14% to 26% of patients. Cases of progressive
multifocal leukoencephalopathy (PML) have occurred in patients
treated with IMBRUVICA®. Monitor patients
for fever and infections and evaluate promptly.
Cytopenias - Treatment-emergent Grade 3 or 4 cytopenias
including neutropenia (range, 19 to 29%), thrombocytopenia (range,
5 to 17%), and anemia (range, 0 to 9%) occurred in patients treated
with 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, acute infections, and a previous history of
atrial fibrillation. Periodically monitor patients clinically for
atrial fibrillation. Patients who develop arrhythmic symptoms
(e.g., palpitations, lightheadedness) or new-onset dyspnea should
have an ECG performed. If atrial fibrillation persists, consider
the risks and benefits of IMBRUVICA®
treatment and dose modification.
Second Primary Malignancies - Other malignancies (range,
5 to 14%) including non-skin carcinomas (range, 1 to 3%) have
occurred in patients treated with
IMBRUVICA®. The most frequent second
primary malignancy was non-melanoma skin cancer (range, 4 to
11%).
Tumor Lysis Syndrome - Tumor lysis syndrome has been
reported with IMBRUVICA® therapy. Monitor
patients closely and take appropriate precautions in patients at
risk for tumor lysis syndrome (e.g., high tumor burden).
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®. 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.
ADVERSE REACTIONS
The most common adverse reactions (>25%) in patients with
B-cell malignancies (MCL, CLL, WM) were thrombocytopenia* (57%,
52%, 43%), neutropenia* (47%, 51%, 44%), diarrhea (51%, 48%, 37%),
anemia* (41%, 36%, 13%), fatigue (41%, 28%, 21%), musculoskeletal
pain (37%, 28%**, NA***), bruising (30%, 12%**, 16%**), nausea
(31%, 26%, 21%), upper respiratory tract infection (34%, 16%, 19%),
and rash (25%, 24%**, 22%**).
*Based on adverse reactions and/or laboratory measurements
(noted as platelets, neutrophils, or hemoglobin decreased).
**Includes multiple ADR terms.
***Not applicable; no associated ADRs.
The most common Grade 3 or 4 non-hematological adverse reactions
(>5%) in MCL patients were pneumonia (7%), abdominal pain (5%),
atrial fibrillation (5%), diarrhea (5%), fatigue (5%), and skin
infections (5%).
Approximately 6% (CLL), 14% (MCL), and 11% (WM) of patients had
a dose reduction due to adverse events.
Approximately 5% (CLL), 9% (MCL), and 6% (WM) of patients
discontinued due to adverse events. Most frequent adverse events
leading to discontinuation were infections, subdural hematomas, and
diarrhea in CLL patients and subdural hematoma (1.8%) in MCL
patients.
DRUG INTERACTIONS
CYP3A Inhibitors - Avoid co-administration with strong
and moderate CYP3A inhibitors. If a moderate CYP3A inhibitor must
be used, reduce the IMBRUVICA® dose.
CYP3A Inducers - Avoid co-administration 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:
http://www.imbruvica.com/downloads/Prescribing_Information.pdf.
About Pharmacyclics
Pharmacyclics, Inc. (NASDAQ: PCYC) is a biopharmaceutical
company focused on developing and commercializing innovative
small-molecule drugs for the treatment of cancer and immune
mediated diseases. The company's mission is to build a viable
biopharmaceutical company that designs, develops and commercializes
novel therapies intended to improve quality of life, increase
duration of life and resolve serious unmet medical needs. It will
do so by identifying and controlling promising product candidates
based on scientific development and administrative expertise,
developing its products in a rapid, cost-efficient manner and,
pursuing commercialization and/or development partners when and
where appropriate.
Pharmacyclics markets IMBRUVICA and has three product candidates
in clinical development and several preclinical molecules in lead
optimization. The company is committed to high standards of ethics,
scientific rigor and operational efficiency as it moves each of
these programs to commercialization. Pharmacyclics is headquartered
in Sunnyvale, CA. To learn more,
please visit www.pharmacyclics.com.
NOTE: This announcement may contain forward-looking
statements made in reliance upon the safe harbor provisions of
Section 27A of the Securities Act of 1933, as amended, and Section
21E of the Securities Exchange Act of 1934, as amended, including
statements, among others, relating to our future capital
requirements, including our expected liquidity position and timing
of the receipt of certain milestone payments, and the sufficiency
of our current assets to meet these requirements, our future
results of operations, our expectations for and timing of ongoing
or future clinical trials and regulatory approvals for any of our
product candidates, and our plans, objectives, expectations and
intentions. Because these statements apply to future events, they
are subject to risks and uncertainties. When used in this
announcement, the words "anticipate", "believe", "estimate",
"expect", "expectation", "goal", "should", "would", "project",
"plan", "predict", "intend", "target" and similar expressions are
intended to identify such forward-looking statements. These
forward-looking statements are based on information currently
available to us and are subject to a number of risks, uncertainties
and other factors that could cause our actual results, performance,
expected liquidity or achievements to differ materially from those
projected in, or implied by, these forward-looking statements.
Factors that may cause such a difference include, without
limitation, our need for substantial additional financing and the
availability and terms of any such financing, the safety and/or
efficacy results of clinical trials of our product candidates, our
failure to obtain regulatory approvals or comply with ongoing
governmental regulation, our ability to commercialize, manufacture
and achieve market acceptance of any of our product candidates, for
which we rely heavily on collaboration with third parties, and our
ability to protect and enforce our intellectual property rights and
to operate without infringing upon the proprietary rights of third
parties. Although we believe that the expectations reflected in the
forward-looking statements are reasonable, we cannot guarantee
future results, performance or achievements and no assurance can be
given that the actual results will be consistent with these
forward-looking statements. For more information about the risks
and uncertainties that may affect our results, please see the Risk
Factors section of our filings with the Securities and Exchange
Commission, including our Form 10-K for the year ended December 31, 2013 and quarterly reports on Form
10-Q. We do not intend to update any of the forward-looking
statements after the date of this announcement to conform these
statements to actual results, to changes in management's
expectations or otherwise, except as may be required by law.
IMBRUVICA is a registered trademark of Pharmacyclics, Inc.
1 IMBRUVICA Prescribing Information, January 2015
2 Genetics Home Reference. Isolated growth hormone
deficiency. Available at:
http://ghr.nlm.nih.gov/condition/isolated-growth-hormone-deficiency.
Accessed May 2015.
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SOURCE Pharmacyclics, Inc.