Today, Pfizer Inc. and its partner Avillion LLP announced
results from the Phase 3 BFORE (Bosutinib trial in First line chrOnic myelogenous leukemia tREatment) trial demonstrating superiority
of BOSULIF® (bosutinib) over imatinib as a first-line treatment for
patients with chronic phase Philadelphia chromosome positive (Ph+)
chronic myeloid leukemia (CML). The study met its primary endpoint
of major molecular response (MMR) at 12 months. No new or
unexpected safety issues were identified. BOSULIF is currently
indicated in the U.S. and EU for the treatment of adult patients
with Ph+ CML with resistance or intolerance to prior therapy.
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“Since its approval, the efficacy and distinct tolerability
profile of BOSULIF has provided an important treatment option for
patients with Ph+ CML who are resistant or intolerant to prior
therapy. The positive outcome of the BFORE study represents a
key step in potentially broadening treatment options for patients
in the first-line setting,” said Mace Rothenberg, MD, chief
development officer, Oncology, Pfizer Global Product Development.
“This is an important milestone for Pfizer’s emerging hematology
portfolio as we work to develop new treatments for patients with
acute and chronic hematologic malignancies.”
“This successful partnership between Pfizer and Avillion is good
news for CML patients because additional first-line treatment
options allow physicians to tailor therapy based on individual
patient considerations,” said Allison Jeynes-Ellis, MD, Chief
Executive Officer of Avillion. “The outcome of this partnership
reinforces our belief in the potential of our innovative business
model for the co-development and partnership of late-stage clinical
candidates.”
Based on the results of the study, Pfizer will work with the
U.S. Food and Drug Administration (FDA) and other regulatory
authorities to potentially make BOSULIF available for Ph+ CML
patients in the first-line setting. Detailed efficacy and safety
data from this study will be submitted for a future congress or
peer-reviewed journal.
Pfizer and Avillion entered into an exclusive collaborative
development agreement in 2014 to conduct the BFORE trial. Under the
terms of the agreement, Avillion provided funding and conducted the
trial to generate the clinical data that will be used to support
potential regulatory filings for marketing authorization of BOSULIF
as first-line treatment of patients with chronic phase Ph+ CML. If
approved for this indication, Avillion will be eligible to receive
milestone payments from Pfizer. Pfizer retains all rights to
commercialize BOSULIF globally.
Pfizer is advancing a broad range of therapies that leverage
select pathways and mechanisms of action to address acute and
chronic leukemias, myeloproliferative disorders and lymphoma.
About the BFORE Study
BFORE (Bosutinib trial in
First line chrOnic myelogenous leukemia tREatment) is a multi-center, open-label
Phase 3 study designed to assess the effectiveness and safety of
BOSULIF® (bosutinib) as a first-line treatment for patients with
chronic phase Ph+ CML. The study enrolled 536 patients at multiple
sites in North America, Asia and Europe. Patients were randomized
1:1 to receive BOSULIF 400mg or imatinib, a standard of care, for
the duration of the study. The primary outcome was to show
superiority of bosutinib over imatinib at 12 months by comparing
MMR, or the proportion of patients in each arm whose levels of the
Bcr-Abl1 kinase have dropped below 0.1%.
ABOUT BOSULIF® (bosutinib)
BOSULIF® (bosutinib) is an oral, once-daily, tyrosine kinase
inhibitor (TKI), which inhibits the Bcr-Abl kinase that promotes
CML; it is also an inhibitor of Src-family kinases. BOSULIF® was
approved in September 2012 in the U.S. for the treatment of adult
patients with Ph+ CML with resistance or intolerance to prior
therapy and offers an important treatment option for these
patients. In Europe, BOSULIF was granted conditional marketing
authorization in March 2013 for the treatment of adult patients
with Ph+ CML previously treated with one or more TKIs and for whom
imatinib, nilotinib and dasatinib are not considered appropriate
treatment options. The current approved dose of BOSULIF® is 500 mg
orally once daily with food. For more information on BOSULIF
resources available for healthcare professionals and patients,
please visit www.BOSULIF.com.
IMPORTANT BOSULIF® (bosutinib) SAFETY INFORMATION
Contraindication: Hypersensitivity to BOSULIF.
Anaphylactic shock occurred in less than 0.2% of treated
patients.
Gastrointestinal Toxicity: Diarrhea, nausea, vomiting,
and abdominal pain can occur. In the clinical trial, median time to
onset for diarrhea was 2 days, median duration was 1 day, and
median number of episodes per patient was 3 (range 1-221). Monitor
and manage patients using standards of care, including
antidiarrheals, antiemetics, and/or fluid replacement. Withhold,
dose reduce, or discontinue BOSULIF as necessary.
Myelosuppression: Thrombocytopenia, anemia, and
neutropenia can occur. Perform complete blood counts weekly for the
first month and then monthly or as clinically indicated. Withhold,
dose reduce, or discontinue BOSULIF as necessary.
Hepatic Toxicity: Twenty percent of patients experienced
an increase in either ALT or AST. Liver enzyme elevation usually
occurs early in treatment. Perform hepatic enzyme tests monthly for
the first 3 months and as clinically indicated. In patients with
transaminase elevations, monitor liver enzymes more frequently.
Drug-induced liver injury has occurred. Withhold, dose reduce, or
discontinue BOSULIF as necessary. In patients with mild, moderate,
or severe hepatic impairment, the recommended starting dose is 200
mg daily.
Renal Toxicity: An on-treatment decline in estimated
glomerular filtration rate has occurred in patients treated with
BOSULIF. Monitor renal function at baseline and during therapy,
with particular attention to patients with preexisting renal
impairment or risk factors. Consider dose adjustment in patients
with baseline and treatment emergent renal impairment. The
recommended starting doses for patients with severe renal
impairment (CrCL <30 mL/min) or moderate renal impairment (CrCL
30-50 mL/min) are 300 mg and 400 mg daily, respectively.
Fluid Retention: Fluid retention can occur and may cause
pericardial effusion, pleural effusion, pulmonary edema, and/or
peripheral edema. Monitor and manage patients using standards of
care. Interrupt, dose reduce, or discontinue BOSULIF as
necessary.
Embryofetal Toxicity: BOSULIF may cause fetal harm when
administered to a pregnant woman. Women of childbearing potential
should be advised of potential hazard to the fetus and to avoid
becoming pregnant while receiving BOSULIF.
Adverse Reactions: The most common adverse reactions
observed in greater than 20% of patients in the Phase 1/2 safety
population (N=546) were diarrhea, nausea, thrombocytopenia,
vomiting, abdominal pain, rash, anemia, pyrexia, and fatigue. The
most common Grade 3/4 adverse reactions and laboratory
abnormalities observed in greater than 10% of patients were
thrombocytopenia, anemia, and neutropenia.
CYP3A Inhibitors and Inducers: Avoid concurrent use with
strong or moderate CYP3A inhibitors or inducers.
Proton Pump Inhibitors: Consider using short-acting
antacids or H2 blockers instead of PPIs to avoid a reduction in
BOSULIF exposure. Separate antacid or H2 blocker dosing and BOSULIF
dosing by more than 2 hours.
Nursing Mothers: Given the potential for serious adverse
reactions in nursing infants, a decision should be made whether to
discontinue nursing or BOSULIF, taking into account the importance
of the drug to the mother.
Please see full Prescribing Information at www.bosulif.com.
About Pfizer Oncology
Pfizer Oncology is committed to pursuing innovative treatments
that have a meaningful impact on those living with cancer. As a
leader in oncology speeding cures and accessible breakthrough
medicines to patients, Pfizer Oncology is helping to redefine life
with cancer. Our strong pipeline of biologics, small molecules and
immunotherapies is one of the most robust in the industry, and is
studied with precise focus on identifying and translating the best
scientific breakthroughs into clinical application for patients
across a wide range of cancers. By working collaboratively with
academic institutions, individual researchers, cooperative research
groups, governments and licensing partners, Pfizer Oncology strives
to cure or control cancer with its breakthrough medicines. Because
Pfizer Oncology knows that success in oncology is not measured
solely by the medicines you manufacture, but rather by the
meaningful partnerships you make to have a more positive impact on
people’s lives. Learn more about how Pfizer Oncology is applying
innovative approaches to improve the outlook for people living with
cancer at
http://www.pfizer.com/research/therapeutic_areas/oncology.
Working together for a healthier world®
At Pfizer, we apply science and our global resources to bring
therapies to people that extend and significantly improve their
lives. We strive to set the standard for quality, safety and value
in the discovery, development and manufacture of health care
products. Our global portfolio includes medicines and vaccines as
well as many of the world's best-known consumer health care
products. Every day, Pfizer colleagues work across developed and
emerging markets to advance wellness, prevention, treatments and
cures that challenge the most feared diseases of our time.
Consistent with our responsibility as one of the world's premier
innovative biopharmaceutical companies, we collaborate with health
care providers, governments and local communities to support and
expand access to reliable, affordable health care around the world.
For more than 150 years, we have worked to make a difference for
all who rely on us. We routinely post information that may be
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addition, to learn more, please visit us on www.pfizer.com and
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About Avillion
Avillion LLP is a drug development company with an innovative
business model focusing on the clinical co-development and
regulatory approval of late stage pharmaceutical products. Avillion
offers a compelling opportunity to partner late-stage therapeutic
projects for approval in the US and EU and to accelerate their
availability to the market. Our objective is to enable our partners
to continue to develop the drug candidates in their pipeline at the
highest quality without increasing the burden on their P&L or
cash reserves. Avillion can achieve this by incurring 100% of the
clinical and regulatory risk, while advancing the development of
these late-stage assets in return for milestone payments on the
commercialisation of successfully developed products.
Avillion was founded in 2012 in London, UK, and is backed by
Abingworth, Clarus Ventures and Royalty Pharma.
http://www.avillionllp.com
PFIZER DISCLOSURE NOTICE: The information contained in
this release is as of December 5, 2016. Pfizer assumes no
obligation to update forward-looking statements contained in this
release as the result of new information or future events or
developments.
This release contains forward-looking information about BOSULIF
(bosutinib), including a potential new indication for BOSULIF for
the first-line treatment for patients with Ph+ CML, and its
potential benefits, that involves substantial risks and
uncertainties that could cause actual results to differ materially
from those expressed or implied by such statements. Risks and
uncertainties include, among other things, the uncertainties
inherent in research and development, including, without
limitation, the ability to meet anticipated trial commencement and
completion dates and regulatory submission dates, as well as the
possibility of unfavorable clinical trial results, including
unfavorable new clinical data and additional analyses of existing
clinical data; uncertainties regarding the commercial success of
BOSULIF; whether and when any applications for the potential new
indication may be filed with regulatory authorities in any
jurisdictions; whether and when regulatory authorities in any
jurisdictions may approve such applications, which will depend on
the assessment by such regulatory authorities of the benefit-risk
profile suggested by the totality of the efficacy and safety
information submitted; decisions by regulatory authorities
regarding labeling and other matters that could affect the
availability or commercial potential of BOSULIF, including for the
potential new indication; and competitive developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2015 and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned “Risk Factors” and
“Forward-Looking Information and Factors That May Affect Future
Results”, as well as in its subsequent reports on Form 8-K, all of
which are filed with the SEC and available at www.sec.gov and
www.pfizer.com.
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version on businesswire.com: http://www.businesswire.com/news/home/20161205005343/en/
Pfizer MediaSally Beatty, 212-733-6566orPfizer InvestorsRyan
Crowe, 212-733-8160orAvillionAllison Jeynes-Ellis, +44 (0)203 764
9531orAvillion MediaCitigate Dewe RogersonMark Swallow, +44 (0)207
282 2948
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