PALOMA-3 Data to Be Presented at the 2015
Annual Meeting of the American Society of Clinical Oncology (ASCO)
and Published in The New England Journal of Medicine
Pfizer Inc. (NYSE:PFE) today announced study results
demonstrating palbociclib in combination with fulvestrant was
superior to treatment with a standard of care, fulvestrant, by
significantly extending progression-free survival (PFS) in women
with hormone receptor-positive (HR+), human epidermal growth factor
receptor 2-negative (HER2-) metastatic breast cancer whose disease
has progressed during or after endocrine therapy (HR 0.42, median
PFS, 9.2 vs. 3.8 months, in their respective arms, p<0.000001).
Results from the Phase 3 PALOMA-3 study will be featured today in a
press briefing during the 51st Annual Meeting of the American
Society of Clinical Oncology (ASCO) and will be presented as a
late-breaker on Monday, June 1 at 8:00 a.m. CDT (Abstract #LBA502).
The results will also be simultaneously published online by The New
England Journal of Medicine. The Principal Investigator for the
study, Nicholas C. Turner, MD, PhD, consultant medical oncologist
at The Royal Marsden and Institute of Cancer Research in London,
United Kingdom, will present these data.
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“The current treatment options available for patients with this
type of metastatic breast cancer present challenges for physicians
and patients, as demonstrated by the limited clinical benefit of
additional lines of endocrine therapy, and by the difficult side
effects of chemotherapy,” said Dr. Turner. “The PALOMA-3 results
demonstrate that palbociclib in combination with fulvestrant more
than doubled the time before disease progression compared to
fulvestrant alone, and suggest that palbociclib could be a
promising treatment option for women with HR+, HER2- metastatic
breast cancer after progression on endocrine therapy.”
“The results of PALOMA-3 are compelling and provide evidence
that could potentially expand the role of palbociclib as an
innovative first-in-class therapy for patients with metastatic
breast cancer,” said Dr. Mace Rothenberg, senior vice president of
Clinical Development and Medical Affairs and chief medical officer
for Pfizer Oncology.
PALOMA-3 (also known as Study A5481023) is a multi-center trial
with more than 140 global sites participating and 521 patients
enrolled. The study is a randomized (2:1), double-blind Phase 3
study designed to assess the PFS of palbociclib (125 mg once daily
orally for three out of four weeks in each cycle) in combination
with fulvestrant (500 mg intramuscularly on days 1 and 15 of cycle
1, and then on day 1 of each subsequent 28 day cycle) versus
fulvestrant plus placebo in pre/perimenopausal and postmenopausal
women with HR+, HER2- metastatic breast cancer whose disease has
progressed during or after endocrine therapy. Pre/perimenopausal
women also received ovarian suppression (goserelin). PFS is defined
as time from randomization to time of disease progression or death
from any cause.
As previously disclosed, the PALOMA-3 study met its primary
endpoint of PFS at the interim analysis and was stopped early in
April 2015 due to efficacy based on an assessment by an independent
Data Monitoring Committee (DMC). Benefit from palbociclib was also
demonstrated across all pre-specified subgroups, including both
pre/perimenopausal and postmenopausal patients. At the time of the
PFS analysis, overall survival (OS) data was immature.
The adverse events observed with palbociclib in combination with
fulvestrant in PALOMA-3 were consistent with their respective
labeled adverse event profiles. The most common adverse events
reported for the palbociclib-fulvestrant group were neutropenia,
leukopenia, fatigue and nausea. The rate of febrile neutropenia
(0.6%) was the same in both arms in the study. Serious adverse
events were balanced across arms in the study. The discontinuation
rate due to adverse events was 2.6% on the palbociclib plus
fulvestrant arm and 1.7% on the fulvestrant plus placebo arm.
Based on the results of PALOMA-3, Pfizer is in discussions with
global regulatory authorities to determine next steps to
potentially make palbociclib available for women with HR+, HER2-
metastatic breast cancer whose disease has progressed following
endocrine therapy. As previously disclosed, Pfizer intends to file
a Marketing Authorisation Application for palbociclib to the
European Medicines Agency (EMA) in the second half of 2015. In
addition, Pfizer will work closely with the FDA to review these
data and determine next steps for potential inclusion in the U.S.
label.
Palbociclib, under the brand name IBRANCE®, was approved in
combination with letrozole by the U.S. Food and Drug Administration
(FDA) in February 2015 for the treatment of postmenopausal women
with estrogen receptor-positive (ER+)/HER2- advanced breast cancer
as initial endocrine-based therapy for their metastatic disease.1
This indication is approved under accelerated approval based on
PFS. Continued approval for this indication may be contingent upon
verification and description of clinical benefit in a confirmatory
trial. The confirmatory Phase 3 trial, PALOMA-2, is fully enrolled.
IBRANCE is not approved for the use being investigated in
PALOMA-3.
The full prescribing information for IBRANCE can be found at
www.IBRANCE.com.
About IBRANCE®
IBRANCE (palbociclib) 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.1
The effectiveness of IBRANCE in these patients is based on a
study that measured progression-free survival.1 Continued approval
for this indication may be contingent upon verification and
description of clinical benefit in a confirmatory trial.
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 30, 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) that involves substantial risks and uncertainties
that could cause actual results to differ materially from those
expressed or implied by such statements. Forward-looking statements
include those about IBRANCE’s potential benefits, about a planned
filing of a Marketing Authorisation Application for palbociclib in
Europe and about a potential indication for the treatment of women
with HR+/HER2- metastatic breast cancer in combination with
endocrine therapy. 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 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 or supplemental drug
applications may be filed with the European Medicines Agency, U.S.
Food and Drug Administration, or in any other jurisdictions for
potential HR+/HER2- metastatic breast cancer indications 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.
1 IBRANCE® (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,
347-330-7867orInvestor:Ryan Crowe, 215-260-0914
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