Phase 3 Top-Line Results Show IBRANCE in
Combination with Fulvestrant Meets Progression-Free Survival (PFS)
Primary Endpoint
Pfizer Inc. (NYSE:PFE) today announced that the Phase 3 PALOMA-3
trial for IBRANCE® (palbociclib) met its primary endpoint of
demonstrating an improvement in progression-free survival (PFS) for
the combination of IBRANCE plus fulvestrant compared with
fulvestrant plus placebo in women with hormone receptor positive
(HR+), human epidermal growth factor receptor 2 negative (HER2-)
metastatic breast cancer following disease progression during or
after endocrine therapy. The study was stopped early due to
efficacy based on an assessment by an independent Data Monitoring
Committee (DMC). These are the first randomized Phase 3 trial
results for IBRANCE, a new anti-cancer medicine with the novel
mechanism of cyclin-dependent kinase 4/6 (CDK 4/6) inhibition.
“The results of this trial are especially important because they
help us understand the potential of IBRANCE to improve outcomes in
patients with this difficult to treat cancer. We’re gratified to be
able to stop the trial early and are engaging in discussions with
health authorities regarding a regulatory path forward,” said Dr.
Mace Rothenberg, senior vice president of Clinical Development and
Medical Affairs and chief medical officer for Pfizer Oncology.
The adverse events observed with IBRANCE in combination with
fulvestrant in PALOMA-3 were generally consistent with their
respective known adverse event profiles. Detailed efficacy and
safety results from PALOMA-3 will be submitted for presentation at
the American Society of Clinical Oncology (ASCO) 2015 Annual
Meeting.
IBRANCE was approved by the U.S. Food and Drug Administration
(FDA) in February 2015 as a first-line treatment for women with
advanced or metastatic estrogen receptor positive, human epidermal
growth factor receptor 2 negative (ER+/HER2-) breast cancer.
IBRANCE® (palbociclib), in combination with letrozole, is indicated
for the treatment of postmenopausal women with ER+/HER2- advanced
breast cancer as initial endocrine-based therapy for their
metastatic disease.i This indication is approved under accelerated
approval based on PFS.i 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 or for any indication in any market
outside the U.S.
The full prescribing information for IBRANCE can be found at
www.IBRANCE.com.
Important IBRANCE (palbociclib) Safety Information from the
U.S. Prescribing 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 PALOMA-3
PALOMA-3 (also known as Study A5481023) is a randomized (2:1),
multi-center, double blind Phase 3 study designed to assess the PFS
of IBRANCE (125 mg once daily for three out of four weeks in
repeated cycles) in combination with fulvestrant versus fulvestrant
(500 mg intramuscularly on days 1 and 15 of cycle 1, and then on
day 1 of each subsequent 28 day cycle) plus placebo in women with
HR+, HER2- metastatic breast cancer whose disease has progressed
during or after endocrine therapy. PFS is defined as time from
randomization to time of disease progression or death from any
cause. PALOMA-3 is a multi-center trial with more than 150 global
sites participating and 521 patients enrolled.
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 April 15, 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 and about a
potential indication for the treatment of women with HR+/HER2-
metastatic breast cancer following disease progression after prior
endocrine therapy (the “Potential Indication”). 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 for the indication for the first-line
treatment of postmenopausal women with ER+/HER2- advanced breast
cancer as initial endocrine-based therapy in combination with
letrozole for their metastatic disease (the “Approved U.S.
Indication”) 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 any jurisdictions other than the U.S.
for the Approved U.S. Indication or in any jurisdictions for any
other potential indications for IBRANCE, including the Potential
Indication; 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 the Existing U.S. Indication or any other such indications,
including the Potential 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, 2014 and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned “Risk Factors” and
“Forward-Looking Information 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.
i IBRANCE® (palbociclib) Prescribing Information. New York. NY:
Pfizer Inc: 2015.
Pfizer Inc.Media:Sally Beatty,
212-733-6566orInvestors:Ryan Crowe, 212-733-8160
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