SUNNYVALE, Calif., May 28, 2015 /PRNewswire/ -- Pharmacyclics,
Inc. today announced the initiation of PCYC-1136-CA, a multi-center
study that will investigate the use of ibrutinib
(IMBRUVICA®) in combination with MEDI4736, an
investigational anti-PD-L1 immune checkpoint inhibitor being
developed by AstraZeneca. The Phase Ib/II study will examine the
safety, tolerability and effectiveness of this investigational
combination in patients with relapsed or refractory (R/R) diffuse
large B-cell lymphoma (DLBCL) or follicular lymphoma (FL).
IMBRUVICA is jointly developed and commercialized by Pharmacyclics
and Janssen Biotech, Inc.
"While there has been a great deal of progress in developing
therapies to treat certain B-cell malignancies, additional
treatment options for the most refractory types of blood cancers
are still needed," said Darrin
Beaupre, M.D., Ph.D., Head of Early Development and
Immunotherapy at Pharmacyclics. "Given the pre-clinical activity we
have observed by combining therapies such as ibrutinib and
immunotherapy agents, we are excited to investigate the potential
to improve the outcomes of patients who are no longer benefitting
from the currently available therapies."
The Phase Ib portion of the study will primarily seek to
determine the safety, tolerability, and appropriate dose of
ibrutinib when combined with MEDI4736 to treat individuals with R/R
DLBCL or FL. The Phase II portion of the study will be conducted in
two distinct cohorts to determine the safety and effectiveness of
the treatment combination in patients with these types of blood
cancer.
The clinical study will aim to enroll approximately 109 patients
at several sites in the U.S. To learn more about the clinical
study, visit: www.clinicaltrials.gov or call Pharmacyclics Medical
Information at 877-877-3536.
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 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. Continued approval for this
indication may be contingent upon verification of clinical benefit
in confirmatory trials.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 67 trials are
registered on www.clinicaltrials.gov.
To learn more about the medical terminology used in this news
release, please visit
http://stedmansonline.com/.
IMPORTANT SAFETY INFORMATION
Warnings and precautions include hemorrhage, infections,
cytopenias, atrial fibrillation, second primary malignancies, Tumor
Lysis Syndrome and embryo-fetal toxicity.
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. For
additional important safety information, please see Important
Safety Information to the right and the full Prescribing
Information at
www.imbruvica.com/downloads/Prescribing_Information.pdf.
About Pharmacyclics, An AbbVie Company
Pharmacyclics, 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 three 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.
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.