SUNNYVALE, Calif., March 19, 2015 /PRNewswire/ --
Pharmacyclics, Inc. (NASDAQ: PCYC) today announced that new
pre-clinical and clinical data for ibrutinib
(IMBRUVICA®) will be highlighted at the 2015 American
Association for Cancer Research (AACR) Annual Meeting to be held
April 18 – 22, 2015, in Philadelphia, PA. Several company-sponsored
and investigator-initiated abstracts have been accepted for
presentation as oral and poster sessions highlighting data in solid
tumor and blood cancers. IMBRUVICA is jointly developed and
commercialized by Pharmacyclics and Janssen Biotech, Inc.
"We are very encouraged by the ibrutinib data we are seeing both
as a single agent and as a synergistic combination with other
treatment options across solid tumor and new hematologic
histologies," said Betty Chang,
Ph.D., Head of Research at Pharmacyclics. "Based on the success to
date within ibrutinib's approved and investigational uses, we
remain committed to exploring the further potential of ibrutinib as
a backbone of therapy within the broader oncology and hematology
arenas."
A select list of accepted ibrutinib abstracts is included below.
A full list of accepted ibrutinib data abstracts is available on
the AACR website.
Presentations:
Oral Presentation
Long-term treatment with
single-agent ibrutinib 420 mg leads to durable responses including
complete responses in CLL (Abstract CT132)
Clinical
Trials Minisymposium. Sunday, April
19 at 3:15 p.m. ET in Room
103
Lead Author: Steven
Coutre, Stanford University,
Stanford, CA
Poster Presentations
Combining ibrutinib with immune checkpoint blockade to induce
therapeutic antitumor immune response in solid tumors (Abstract
251; Poster 9)
Immune Checkpoints. Sunday, April 19, 2015 at 1:00 - 5:00 p.m. ET in Section 12
Lead
Author: Idit Sagiv-Barfi,
Stanford University, Stanford, CA
Ibrutinib enhances the anti-tumor efficacy of CTLA-4 blockade
in lymphoma and colon cancer models (Abstract 259; Poster
17)
Immune Checkpoints. Sunday,
April 19, 2015 at 1:00 - 5:00 p.m.
ET in Section 12
Lead Author: Patrick Ng, Pharmacyclics, Inc., Sunnyvale, CA
Ibrutinib exerts potent antifibrotic activity in a mouse
model of pancreatic adenocarcinoma (Abstract 396; Poster
5)
Crosstalk of the Microenvironment and the Tumor Clone.
Sunday, April 19, 2015 at
1:00 - 5:00 p.m. ET in Section
17
Lead Author: Daniel
Masso-Valles, Vall d'Hebron Institute of Oncology (VHIO),
Barcelona, Spain
Ibrutinib plus proteasome or MALT1 inhibitors overcome
resistance to BCR antagonists in CARD11 mutant-expressing
B-lymphoma cells (Abstract 1742; Poster 15)
Inhibitors of
UPS and HSP90 Pathways and Other Targets. Monday, April 20, 2015 at 8:00 a.m. - 12:00 p.m. ET in Section
31
Lead Author: Ling Xue,
Pharmacyclics, Inc, Sunnyvale,
CA
Ibrutinib significantly improves survival in a human Burkitt
lymphoma (BL) xenograft NSG mouse model: Ibrutinib may be a
potential adjuvant agent in the treatment of BL (Abstract 2608;
Poster 30)
MAPK, EGFR, and BTK Inhibitors. Monday,
April 20, 2015 at 1:00 - 5:00 p.m.
ET in Section 29
Lead Author: Sanghoon Lee, New York
Medical College, Valhalla,
NY
Synergistic effect of ibrutinib and inhibitors targeting TLR
signaling in ABC subtype of diffuse large B-Cell lymphoma (Abstract
2598; Poster 20)
MAPK, EGFR, and BTK Inhibitors.
Monday, April 20, 2015 at
1:00 - 5:00 p.m. ET in Section
29
Lead Author: Hsu-Ping Kuo,
Pharmacyclics, Inc., Sunnyvale,
CA
The BTK inhibitor ibrutinib (PCI-32765) overcomes paclitaxel
resistance resulting from the overexpression of ABCB1 and ABCC10
transporters (Abstract 2697; Poster 19)
Resistance to
Pathway-Targeted Therapeutics 1. Monday,
April 20, 2015 at 1:00 - 5:00 p.m.
ET in Section 33
Lead Author: Hui Zhang, Shandong Cancer Hospital and
Institute, Jinan, China
Specific antitumor activity of the splicing modulator
sudemycin and cooperation with ibrutinib in chronic lymphocytic
leukemia (Abstract 2584; Poster 6)
MAPK, EGFR, and BTK
Inhibitors. Monday, April 20, 2015 at
1:00 - 5:00 p.m. ET in Section
29
Lead Author: Sílvia Xargay-Torrent, IDIBAPS, Barcelona, Spain
About IMBRUVICA
IMBRUVICA (ibrutinib) is a
first-in-class, oral, once-daily therapy that inhibits a protein
called Bruton's tyrosine kinase (BTK).1 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 approved for the treatment of patients with chronic
lymphocytic leukemia (CLL) who have received at least one prior
therapy, CLL patients with del 17p, a genetic mutation that occurs
when part of chromosome 17 has been lost, and patients with
Waldenstrom's macroglobulinemia.1
IMBRUVICA is also approved for the treatment of patients with
mantle cell lymphoma (MCL) who have received at least one prior
therapy. Accelerated approval was granted for the MCL indication
based on overall response rate (ORR). Continued approval for the
MCL indication may be contingent upon verification of clinical
benefit in confirmatory trials.1
IMBRUVICA is being studied alone and in combination with other
treatments in several blood cancers. Over 5,100 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 58 trials are registered on
www.clinicaltrials.gov.
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.
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
- Waldenstrom'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 (eg,
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, neutropenia,
diarrhea, anemia, fatigue, musculoskeletal pain, bruising, nausea,
upper respiratory tract infection, and rash. Seven percent of
patients receiving IMBRUVICA® discontinued treatment due
to adverse events.
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.
For additional important safety information, please see Full
Prescribing Information
at 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 March 2015.
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SOURCE Pharmacyclics, Inc.