Partnership with Pfizer, BIG, GBG, NSABP and
PrECOG to facilitate further investigation of IBRANCE
The Alliance Foundation Trials, LLC (AFT), the
Austrian Breast & Colorectal Cancer Study Group (ABCSG)
and Pfizer Inc. today announced the launch of the
Palbociclib Collaborative Adjuvant
Study, or PALLAS. This global Phase 3 clinical trial
for patients with early-stage breast cancer is being conducted in
conjunction with Breast International Group (BIG), German Breast
Group (GBG), National Surgical Adjuvant Breast and Bowel Project
(NSABP) and PrECOG, LLC (PrECOG). The PALLAS trial will evaluate
whether the addition of IBRANCE® (palbociclib), developed by
Pfizer, to standard therapy will improve disease-free survival and
prevent the disease from recurring. Patients treated in this study
will have cancers that are hormone receptor-positive (HR+), meaning
their growth is fueled by the hormone estrogen, but are negative
for human epidermal growth factor receptor 2 (HER2-), a different
tumor-associated protein. About 60 to 65 percent of breast cancers
in the United States fall into this category.i
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“We are delighted that Alliance was chosen to co-lead the PALLAS
trial along with our partners at ABCSG,” said Monica M.
Bertagnolli, MD, president and chief executive officer of AFT, and
group chair and principal investigator of the Alliance for Clinical
Trials in Oncology. “This exciting study examines a new CDK 4/6
inhibitor that has already demonstrated an impact for breast cancer
patients with metastatic disease. The goal is to determine whether
IBRANCE can also improve the disease-free survival rate in patients
with surgically resectable disease.”
“After intensively working together among trial leadership on
the scientific conception, operational preparation and seamless
transatlantic cooperation for this clinical trial, we are excited
that this study, with the potential to revolutionize adjuvant
therapy for the most common type of breast cancer, is now ready to
start,” said Professor Michael Gnant, MD, FACS, president of the
ABCSG, and head of the Breast Health Center Vienna. “We are
convinced that this global venture has potential to bring great
benefit to our breast cancer patients."
A hallmark of cancer cell growth is loss of control of the cell
cycle, leading to unregulated growth and spread of cancer. A
promising strategy to overcome this process involves inhibition of
enzymes called cyclin-dependent kinases (CDKs), which allows
re-establishment of control of cell growth. iii,iv Recent research
has shown that two related enzymes – CDK 4 and CDK 6 – are among
the primary proteins that accelerate cancer cell growth, and may be
particularly important in HR+ breast tumors. iii,iv Research also
indicates that combining CDK 4/6 inhibitors with endocrine therapy
is beneficial in patients with advanced breast cancer.iii,iv The
new oral, anti-cancer drug IBRANCE blocks CDK 4/6.ii
IBRANCE was approved in February 2015 by the U.S. Food and Drug
Administration (FDA) for the treatment of postmenopausal women with
estrogen receptor-positive (ER+)/HER2- advanced breast cancer as
initial endocrine-based therapy for their metastatic disease. This
indication is approved under accelerated approval based on
progression-free survival, the length of time during or after
treatment a patient lives with a disease but does not get worse.ii
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.
“We have seen exciting news about IBRANCE in 2015, not only from
the accelerated approval based on PALOMA-1, but also from the
results of the PALOMA-3 study, a Phase 3 trial showing the addition
of IBRANCE to the hormone medicine fulvestrant in pre-treated
patients with metastatic HR+/HER2- breast cancer improved clinical
outcomes,” said Erica L. Mayer, MD, MPH, co-principal investigator
of the trial for AFT, Assistant Professor of Medicine at the
Harvard Medical School and Senior Physician at the Susan F. Smith
Center for Women's Cancers and at the Dana-Farber Cancer
Institute.
“The primary endpoint of the PALLAS trial is to look at the time
to disease recurrence in patients who have stage 2 or stage 3
breast cancer,” Dr. Mayer said. “The study is also enriched with an
expansive correlative science program that includes analyses of
patient tissue and blood samples, as well as an in depth analysis
of patient adherence to oral medication and patients’ quality of
life while on study.”
The PALLAS trial is a prospective, two-arm, international,
multicenter, randomized, open-label Phase 3 study. The trial is
open to premenopausal and postmenopausal women or men with stage 2
or stage 3 HR+/HER2- early breast cancer. Participants will be
randomized (selected by chance) to one of two treatment arms. One
study arm will treat patients with IBRANCE (at a dose of 125 mg
orally once daily, day 1 to day 21 followed by seven days off
treatment in a 28-day cycle) for two years and standard endocrine
adjuvant therapy for at least five years. The other study arm will
treat patients with standard endocrine adjuvant therapy alone for
at least five years. Participants will be recruited worldwide.
Approximately 4,600 people are expected to enroll in the trial.
“We’re looking for ways that we can prevent recurrence of breast
cancer in every patient. IBRANCE appears to be very promising in
that regard because it boosted the effect of anti-estrogen
treatments in women who already have recurrent, metastatic breast
cancer,” said Angela DeMichele, MD, MSCE, co-principal investigator
for PrECOG, Miller Associate Professor of Breast Cancer Excellence
in the Rowan Breast Center and Associate Professor of Medicine and
Epidemiology at the Abramson Cancer Center of the University of
Pennsylvania.
The scope of the PALLAS trial is global. AFT and the ABCSG have
brought together a collaborative group of breast cancer specialists
from around the world to team up with Pfizer to form a unique
public-private cancer research partnership aimed at bringing more
innovative therapies to patients in more efficient ways.
“Collaborations of this kind are crucial to advance the science
and general understanding of how we can best treat breast cancer,”
said Maria Koehler, MD, PhD, vice president of Strategy, Innovation
and Collaborations for Pfizer Oncology. “Working together, we will
be able to efficiently answer important clinical questions in order
to potentially bring IBRANCE to patients with early-stage breast
cancer who need the treatment most.”
“Pfizer is honored to partner with prominent breast cancer
research groups to explore the use of IBRANCE for women and men
with HR+/HER2- early-stage breast cancer, which affects millions of
patients each year globally. This collaboration allows Pfizer to
tap into many of the most respected scientific minds and
well-established large global research networks to conduct a large,
international Phase 3 trial,” said Dr. Mace Rothenberg, senior vice
president of Clinical Development and Medical Affairs and chief
medical officer for Pfizer Oncology.
Availability
Currently, the new study is open to physicians and medical
facilities throughout the U.S. if they are associated with
Alliance, NSABP or PrECOG. The study will be available to non-U.S.
sites beginning in October through an extended academic core
network, including the ABCSG and BIG.
Funding and Sponsorship
Pfizer, the manufacturer of IBRANCE, is providing AFT and ABCSG
with funding support for this trial. AFT is sponsoring the trial in
the U.S. and ABCSG for all non-U.S. sites.
For questions about this trial, please contact
PALLAS_AFT@alliancefoundationtrials.org.
Global Partners
About Alliance Foundation Trials, LLC
Alliance Foundation Trials, LLC (AFT) is a research organization
that develops and conducts cancer clinical trials, working closely
with pharmaceutical partners, research collaborators and the
Alliance for Clinical Trials in Oncology member network. AFT seeks
to fulfill the vision of the Alliance for Clinical Trials in
Oncology to reduce the impact of cancer on people by uniting a
broad community of scientists and clinicians from many disciplines,
committed to discovering, validating and disseminating effective
strategies for the prevention and treatment of cancer. AFT is
funded wholly by private entities and does not use any public
funding resources.
About ABCSG
The Austrian Breast & Colorectal Cancer Study Group (ABCSG)
is Austria’s biggest and best-established academic research
organization that internationally successfully performs clinical
trials focusing on the subject of breast and colorectal cancer, and
more recently also on pancreatic cancer and liver metastasis. ABCSG
has over time and dedication achieved a very high public reputation
and patient commitment. In some indications, more than 35 percent
of all breast cancer patients with a given diagnosis are recruited
into ABCSG trials. Since 1984, more than 25,000 patients have
participated in ABCSG studies, and over 900 physicians are part of
the extensive ABCSG’s network. For further information, visit
www.abcsg.com
About BIG
The Breast International Group (BIG) is an international
non-profit organization for academic breast cancer research groups
from around the world. BIG facilitates and accelerates breast
cancer research at the international level by stimulating
cooperation between its 56 member groups and other academic
networks, and collaborating with, but working independently from,
the pharmaceutical industry. Linked to more than 3,000 hospitals,
BIG is the largest international network dedicated solely to breast
cancer. Working together towards one goal: to cure breast cancer!
For more information, visit www.bigagainstbreastcancer.org.
About NSABP Foundation, Inc.
The NSABP Foundation is a not-for-profit academic research
organization, which continues to build upon its nearly 60-year
history of conducting with its member institutions ground-breaking
research studies and educational activities in breast and
colorectal cancers, which are designed to improve the outcome for
cancer patients via improved therapeutic and prevention modalities.
Over the last fifteen years, the Foundation has established full
service capabilities to conduct independently-funded international
research with the private sector to evaluate promising new agents.
More recently, the Foundation continues to maintain a close working
relationship with NCI initiatives as a founding member of NRG
Oncology. Also, it has expanded its service offerings to the
private sector across a wide range of capabilities from
pre-clinical research through Phase 3 clinical trials focused on
biomarker driven studies. For more information visit
www.nsabp.org.
About PrECOG
PrECOG is a not-for-profit limited liability company formed in
2006 by the ECOG Research and Education Foundation, Inc. Through
this relationship, key opinion leaders and the entire network of
ECOG investigators and institutions underpin PrECOG. Funded
entirely outside of the public health system, PrECOG uses an
operational structure separate from ECOG for all facets of clinical
trial management. PrECOG typically functions as the sponsor and
holds the IND, or works under company owned INDs with transfer of
obligations. For more information, visit
www.precogllc.org.
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, visit www.Pfizer.com.
About IBRANCE®
IBRANCE (palbociclib) is an oral inhibitor of CDKs 4 and 6.ii
CDKs 4 and 6 are key regulators of the cell cycle that trigger
cellular progression.iii,iv 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.ii IBRANCE is not approved for the use being
investigated in the PALLAS trial.
The effectiveness of IBRANCE in these patients is based on a
study that measured progression-free survival.ii 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).
PFIZER DISCLOSURE NOTICE: The information contained in
this release is as of August 26, 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), including a potential additional indication for the
treatment of HR+/HER2- early breast cancer 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, 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 U.S. Food and Drug
Administration or any other jurisdictions for initial or additional
indications for IBRANCE, including the potential additional
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 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.
i Decision Resources. Event Driven Pharmacor Report. 2012.
ii IBRANCE® (palbociclib) Prescribing Information. New York. NY:
Pfizer Inc: 2015.
iii 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.
iv 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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version on businesswire.com: http://www.businesswire.com/news/home/20150826005505/en/
Media:Alliance Foundation Trials, LLCCarter
DuFraneMobile:
617-525-8347cdufrane@alliancefoundationtrials.orgorAustrian
Breast & Colorectal Cancer Study Group (ABCSG)Nicole
ScheiberMobile: +43 664 437 98
37nicole.scheiber@abcsg.atorPfizer Inc.Sally BeattyMobile:
(347) 330-7867Sally.Beatty@pfizer.com
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