Pfizer Inc. today announced the launch of a competitive,
peer-reviewed grants program to support clinical research projects
investigating IBRANCE® (palbociclib) in advanced breast cancer. The
multi-year program, which will award a total of up to $3 million in
grants to investigators in the United States, is an extension of
Pfizer’s Advancing Science through Pfizer Investigator Research
Exchange (ASPIRE) initiative. It is the first ASPIRE program to
focus on breast cancer research.
IBRANCE received accelerated approval by the U.S. Food and Drug
Administration in February 2015 for use in combination with
letrozole for the treatment of postmenopausal women with estrogen
receptor-positive, human epidermal growth factor receptor
2-negative (ER+/HER2-) advanced breast cancer as initial
endocrine-based therapy for their metastatic disease.
“We believe the ASPIRE Breast Cancer Research Awards will
contribute important information to our body of knowledge about the
role IBRANCE plays in the treatment and clinical management of
advanced breast cancer, and will complement the robust clinical
development program we have ongoing,” said Dr. Julia Perkins Smith,
senior medical director, U.S. Breast Cancer Lead, Pfizer Oncology.
“Through these awards, we also look forward to supporting the
mission of the ASPIRE program to further academic research and
nurture the career development of emerging investigators in a
disease area of high unmet medical need.”
“This is an exciting opportunity to gain a better understanding
of the efficacy and tolerability of CDK inhibition in ER+ breast
cancer,” said Dr. Ruth O’Regan, head of hematology and oncology in
the Department of Medicine at the University of Wisconsin School of
Medicine and Public Health.
Grantees will be selected through a competitive application
process overseen by an independent review panel of breast cancer
experts.
The review panel encourages investigators (with a special
interest for emerging researchers at Assistant Professor level or
equivalent) to submit applications for innovative research in
several areas. Highlights of the research of interest include:
- Improving the medical knowledge of
palbociclib in the treatment of advanced breast cancer
- Optimizing clinical management during
palbociclib treatment that addresses or improves patient compliance
and convenience and/or patient reported outcomes
For more information about the ASPIRE Breast Cancer Research
Awards and specifics regarding eligible areas of research, please
visit www.aspireresearch.org. The application submission
period ends September 8, 2015, and successful awardees will be
notified in October. Pfizer anticipates providing up to six awards
to investigators in the United States.
About IBRANCE®
IBRANCE is an oral inhibitor of cyclin-dependent kinases (CDKs)
4 and 6.1 CDKs 4 and 6 are key regulators of the cell cycle that
trigger cellular progression.2,3 IBRANCE is indicated in the U.S.
for use in combination with letrozole for the treatment of
postmenopausal women with estrogen receptor-positive, human
epidermal growth factor receptor 2-negative (ER+/HER2-) advanced
breast cancer as initial endocrine-based therapy for their
metastatic disease. The effectiveness of IBRANCE in these patients
is based on a study that measured progression-free survival.
Continued approval for this indication may be contingent upon
verification and description of clinical benefit in a confirmatory
trial.
The full prescribing information for IBRANCE can be found
at www.IBRANCE.com. IBRANCE is not approved for any indication
in any market outside the U.S.
Important IBRANCE (palbociclib) Safety Information
Neutropenia: Neutropenia is frequently reported with
IBRANCE therapy. In the randomized phase II study, Grade 3 (57%) or
4 (5%) decreased neutrophil counts were reported in patients
receiving IBRANCE plus letrozole. Febrile neutropenia can occur.
Monitor complete blood count prior to starting IBRANCE and at the
beginning of each cycle, as well as Day 14 of the first two cycles,
and as clinically indicated. For patients who experience Grade 3
neutropenia, consider repeating the complete blood count monitoring
1 week later. Dose interruption, dose reduction, or delay in
starting treatment cycles is recommended for patients who develop
Grade 3 or 4 neutropenia.
Infections: Infections have been reported at a higher
rate in patients treated with IBRANCE plus letrozole (55%) compared
with letrozole alone (34%). Grade 3 or 4 infections occurred in 5%
of patients treated with IBRANCE plus letrozole vs no patients
treated with letrozole alone. Monitor patients for signs and
symptoms of infection and treat as medically appropriate.
Pulmonary embolism (PE): PE has been reported at a
higher rate in patients treated with IBRANCE plus letrozole (5%)
compared with no cases in patients treated with letrozole alone.
Monitor patients for signs and symptoms of PE and treat as
medically appropriate.
Pregnancy and lactation: Based on the mechanism of
action, IBRANCE can cause fetal harm. Advise females with
reproductive potential to use effective contraception during
therapy with IBRANCE and for at least 2 weeks after the last dose.
Advise females to contact their healthcare provider if they become
pregnant or if pregnancy is suspected during treatment with
IBRANCE. Advise women not to breastfeed while on IBRANCE therapy
because of the potential for serious adverse reactions in nursing
infants from IBRANCE.
Additional hematologic abnormalities: Decreases in
hemoglobin (83% vs 40%), leukocytes (95% vs 26%), lymphocytes (81%
vs 35%), and platelets (61% vs 16%) occurred at a higher rate in
patients treated with IBRANCE plus letrozole vs letrozole
alone.
Adverse reactions: The most common all causality adverse
reactions (≥10%) of any grade reported in patients treated with
IBRANCE plus letrozole vs letrozole alone in the phase II study
included neutropenia (75% vs 5%), leukopenia (43% vs 3%), fatigue
(41% vs 23%), anemia (35% vs 7%), upper respiratory infection (31%
vs 18%), nausea (25% vs 13%), stomatitis (25% vs 7%), alopecia (22%
vs 3%), diarrhea (21% vs 10%), thrombocytopenia (17% vs 1%),
decreased appetite (16% vs 7%), vomiting (15% vs 4%), asthenia (13%
vs 4%), peripheral neuropathy (13% vs 5%), and epistaxis (11% vs
1%).
Grade 3/4 adverse reactions reported (≥10%) occurring at a
higher incidence in the IBRANCE plus letrozole vs letrozole alone
group include neutropenia (54% vs 1%) and leukopenia (19% vs 0%).
The most frequently reported serious adverse events in patients
receiving IBRANCE were pulmonary embolism (4%) and diarrhea
(2%).
General dosing information: The recommended dose of
IBRANCE is 125 mg taken orally once daily for 21 days followed by 7
days off treatment in 28-day cycles. IBRANCE should be taken with
food and in combination with letrozole 2.5 mg once daily
continuously. Patients should be encouraged to take their dose at
approximately the same time each day.
Capsules should be swallowed whole. No capsule should be
ingested if it is broken, cracked, or otherwise not intact. If a
patient vomits or misses a dose, an additional dose should not be
taken that day. The next prescribed dose should be taken at the
usual time.
Management of some adverse reactions may require temporary dose
interruption/delay and/or dose reduction, or permanent
discontinuation. Dose modification of IBRANCE is recommended based
on individual safety and tolerability.
Drug interactions: Avoid concurrent use of strong CYP3A
inhibitors. If patients must be administered a strong CYP3A
inhibitor, reduce the IBRANCE dose to 75 mg/day. If the strong
inhibitor is discontinued, increase the IBRANCE dose (after 3-5
half-lives of the inhibitor) to the dose used prior to the
initiation of the strong CYP3A inhibitor. Grapefruit or grapefruit
juice may increase plasma concentrations of IBRANCE and should be
avoided.
Avoid concomitant use of strong and moderate CYP3A inducers. The
dose of the sensitive CYP3A substrates with a narrow therapeutic
index may need to be reduced as IBRANCE may increase their
exposure.
Hepatic and renal impairment: IBRANCE has not been
studied in patients with moderate to severe hepatic impairment or
in patients with severe renal impairment (CrCl <30 mL/min).
About Pfizer Oncology
Pfizer Oncology is committed to the discovery, investigation and
development of innovative treatment options to improve the outlook
for cancer patients worldwide. Our strong pipeline of biologics and
small molecules, one of the most robust in the industry, 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 breakthrough medicines, to
deliver the right drug for each patient at the right time. For more
information, please visit www.Pfizer.com.
Pfizer Inc.: 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, Pfizer has worked to make a difference for
all who rely on us. To learn more, please visit us at
www.pfizer.com.
DISCLOSURE NOTICE: The information contained in this release is
as of May 28, 2015. 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 IBRANCE
(palbociclib) and the ASPIRE program, including their 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, uncertainties regarding the commercial
success of IBRANCE; the uncertainties inherent in research and
development, including further investigation of the clinical
benefit of IBRANCE, the ability to meet anticipated clinical 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; whether the PALOMA-2 Phase 3 trial of
IBRANCE in combination with letrozole for the treatment of
postmenopausal women with ER+/HER2- advanced breast cancer as
initial endocrine-based therapy for their metastatic disease will
demonstrate a statistically significant improvement in
progression-free survival and whether the other trials of IBRANCE
will meet their primary endpoints; whether regulatory authorities
will be satisfied with the design of and results from our clinical
studies; whether and when drug applications may be filed in
jurisdictions outside the United States for IBRANCE; whether and
when any such applications may be approved by regulatory
authorities, 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 IBRANCE;
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, 2014 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.
1IBRANCE® (palbociclib) Prescribing Information. New York. NY:
Pfizer Inc: 2015.
2 Weinberg RA. pRb and Control of the Cell Cycle Clock. In:
Weinberg RA, ed. The Biology of Cancer. 2nd ed. New York, NY:
Garland Science; 2014:275-329.
3 Sotillo E, Grana X. Escape from Cellular Quiescence. In:
Enders GH, ed. Cell Cycle Deregulation in Cancer. New York, NY:
Humana Press; 2010:3-22.
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Pfizer Inc.Media:Sally Beatty, 212-733-6566orInvestor:Ryan
Crowe, 212-733-8160
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