NEW YORK--(BUSINESS WIRE)--
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
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In addition, to learn more, please visit us on www.pfizer.com
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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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20161205005343/en/
Source: Pfizer Inc. and Avillion LLP