Pfizer and International Cancer Research Groups
collaborate on trial to evaluate new therapeutic combination
The Alliance Foundation Trials, LLC (AFT), in conjunction
with Pfizer and six international cancer research
groups, today announced the launch of PATINA – a randomized,
open-label, Phase 3 clinical study of the cyclin-dependent kinase
4/6 (CDK 4/6) inhibitor palbociclib (also known as IBRANCE®). The
PATINA trial will evaluate palbociclib in combination with
anti-HER2 therapy and endocrine therapy versus standard therapy as
a first-line treatment for patients with hormone receptor-positive
(HR+), human epidermal growth factor receptor 2-positive (HER2+)
metastatic breast cancer. The trial randomized its first patient on
July 26, 2017.
“The PATINA trial offers an exciting opportunity for a new
global collaborative initiative among clinical trial groups aimed
at improving the treatment of women with metastatic breast cancer,”
said Monica M. Bertagnolli, MD, President and Chief Executive
Officer of Alliance Foundation Trials, LLC, and group chair and
principal investigator of the Alliance for Clinical Trials in
Oncology. “Our partnership with the Mastering Breast Cancer
Initiative, PrECOG, the German Breast Group, Fondazione
Michelangelo, SOLTI Breast Cancer Research Group and the Australia
and New Zealand Breast Cancer Trials Group (ANZBCTG) makes this
trial available to patients across the U.S., Europe, Australia and
New Zealand. PATINA is the first study of the Mastering Breast
Cancer Initiative which is an umbrella organization that includes
multiple clinical trials whose participants will contribute medical
information and biological specimens for future research. This
initiative was created in order to understand the natural history
of breast cancer and how it evolves over time with the overall goal
to develop new treatments for this patient population.”
In the U.S., IBRANCE is indicated for the treatment of HR+,
HER2-negative (HER2-) advanced or metastatic breast cancer in
combination with an aromatase inhibitor as initial endocrine-based
therapy in postmenopausal women, or fulvestrant in women with
disease progression following endocrine therapy. Since its initial
FDA approval in 2015, more than 60,000 patients have been treated
with IBRANCE in the U.S. alone.
Pre-clinical data and preliminary results from early phase
clinical trials point to the potential efficacy of palbociclib when
combined with anti-HER2 therapies and endocrine therapy. About
10-15% of patients with metastatic breast cancer are HR+, HER2+.1
Palbociclib is currently not approved for use in this patient
population in any country.
“The current PATINA study is built on strong pre-clinical and
clinical rationale demonstrating the potential of palbociclib when
given in combination with endocrine therapy and anti-HER2
therapies,” said Otto Metzger, MD, principal investigator of the
trial for AFT and Medical Oncologist at the Dana-Farber Cancer
Institute in Boston. “We hope that this trial will show that the
addition of palbociclib to the first-line treatment of HR+, HER2+
disease will help delay the onset of therapeutic resistance to
endocrine therapy, complement the benefits of anti-HER2 therapy and
ultimately improve patient outcomes. The study also includes a
comprehensive molecular characterization of the disease when
patients enter the study and at the time of disease
progression.”
“We are pleased to partner with these prominent research groups
to explore the use of palbociclib in first-line HR+, HER2+
disease,” said Charles Hugh-Jones, MD FRCP, Chief Medical Officer,
Pfizer Oncology. “PATINA is the first randomized, Phase 3 trial of
a CDK 4/6 inhibitor in this setting. Collaborations of this kind
are critical to advance our understanding of how we can treat
breast cancer, and they represent an important part of Pfizer’s
clinical development program for palbociclib.”
The PATINA trial is a pivotal, open-label, international,
multicenter, randomized Phase 3 study. The trial is open to women
or men with HR+, HER2+ metastatic breast cancer following
completion of induction with anti-HER2 based chemotherapy.
Participants will be randomized (selected by chance) to one of two
treatment arms following 6-8 cycles of chemotherapy with anti-HER2
therapy. One study arm will treat patients with palbociclib (at a
dose of 125 mg orally once daily for 21 days followed by seven days
off treatment in a 28-day cycle) and standard anti-HER2 therapy and
endocrine therapy until disease progression. The other study arm
will treat patients with standard anti-HER2 therapy and endocrine
therapy until disease progression. About 500 participants will be
recruited worldwide.
Alliance Foundation Trials, LLC, under the auspices of the
Alliance for Clinical Trials in Oncology, has brought together a
collaborative group of breast cancer specialists from around the
world to team up with a pharmaceutical sponsor to form a
public-private cancer research partnership aimed at bringing more
innovative therapies to patients in more efficient ways.
For questions about this trial, please contact the PATINA study
at patina@alliancefoundatiotrials.org.
Availability
Currently, the new study is open to physicians and medical
facilities throughout the U.S. if they are associated with the
Alliance Foundation and PrECOG oncology research groups. The study
will be available to non-U.S. sites this fall through an extended
academic core network that includes the German Breast Group (GBG),
Fondazione Michelangelo, SOLTI Breast Cancer Research Group, and
the Australia and New Zealand Breast Cancer Trials Group
(ANZBCTG).
Information on the PATINA study can be found on the National
Institutes of Health (NIH) registry of clinical trials,
www.clinicaltrials.gov (Clinicaltrials.gov Identifier:
NCT02947685), and on the PATINA website at
www.patina-trial.com.
Funding and Sponsorship
Pfizer, the manufacturer of palbociclib (IBRANCE®), is providing
funding support for this trial. AFT is the global sponsor of this
trial which will be conducted in the U.S., Germany, Italy, Spain,
Australia, and New Zealand.
About Alliance Foundation Trials, LLC
Alliance Foundation Trials, LCC (AFT), is a limited liability
research organization that develops and conducts cancer clinical
trials in all areas, working closely with industry partners. AFT is
funded wholly by private entities and does not use any public
funding resources. Its operational structure and clinical trials
management mechanism are separate from the Alliance for Clinical
Trials in Oncology although AFT operates under its auspices. For
more information about AFT, visit
www.AllianceFoundationTrials.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 the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN)
investigators and institutions underpin PrECOG. Funded
entirely outside of the public health system, PrECOG uses an
operational structure separate from ECOG-ACRIN for all facets of
clinical trial management. For more information, visit
www.precogllc.org.
About German Breast Group (GBG)
GBG is an independent academic research organization founded in
2003 whose aims are the continuous improvement of breast cancer
treatment and a nationwide increase in therapy quality. GBG
comprises a network of 500 study centers and more than 1,000 study
doctors, resulting in >50,000 enrolled patients so far in their
clinical trials.
About SOLTI
SOLTI Breast Cancer Research Group is a nonprofit organization
dedicated to clinical research in breast cancer. Established in
1995, the clinical trials performed by SOLTI are designed to answer
questions of major scientific interest and clinical relevance.
About Fondazione Michelangelo
The Michelangelo Foundation is a nonprofit scientific
foundation, officially recognized as a foundation since 1991. This
foundation collaborates with Italian and international researchers
to carry out innovative methods of study to improve cancer
diagnosis and care systems. Michelangelo Foundation is particularly
committed to training and dissemination of results of its research
throughout the Italian and international medical community.
About Australia New Zealand Breast Cancer Trial Group
(ANZBCTG)
The ANZBCTG is the largest independent breast cancer clinical
trials research group in Australia and New Zealand. For almost 40
years, the ANZBCTG has conducted clinical trials for the treatment,
prevention, and cure of breast cancer. The Group’s research program
involves multicentre national and international clinical trials
with more than 800 members at 90 institutions. It is committed to
finding new and better treatments and prevention strategies for
every person affected by breast cancer, the goal being to save
lives today and in the future.
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, 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 its breakthrough medicines. 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.
About IBRANCE® (palbociclib) 125 mg
capsules
IBRANCE is an oral inhibitor of CDKs 4 and 6,2 which are key
regulators of the cell cycle that trigger cellular progression.3,4
In the U.S., IBRANCE is indicated for the treatment of HR+, HER2-
advanced or metastatic breast cancer in combination with an
aromatase inhibitor as initial endocrine based therapy in
postmenopausal women, or fulvestrant in women with disease
progression following endocrine therapy. Including the U.S.,
IBRANCE is approved in more than 65 countries.
Important IBRANCE (palbociclib) Safety Information from the
U.S. Prescribing Information
Neutropenia was the most frequently reported adverse
reaction in PALOMA-2 (80%) and PALOMA-3 (83%). In PALOMA-2, Grade 3
(56%) or 4 (10%) decreased neutrophil counts were reported in
patients receiving IBRANCE plus letrozole. In PALOMA-3, Grade 3
(55%) or Grade 4 (11%) decreased neutrophil counts were reported in
patients receiving IBRANCE plus fulvestrant. Febrile neutropenia
has been reported in 1.8% of patients exposed to IBRANCE across
PALOMA-2 and PALOMA-3. One death due to neutropenic sepsis was
observed in PALOMA-3. Inform patients to promptly report any
fever.
Monitor complete blood count prior to starting IBRANCE, at the
beginning of each cycle, on Day 15 of first 2 cycles and as
clinically indicated. Dose interruption, dose reduction, or delay
in starting treatment cycles is recommended for patients who
develop Grade 3 or 4 neutropenia.
Based on the mechanism of action, IBRANCE can
cause fetal harm. Advise females of reproductive
potential to use effective contraception during IBRANCE treatment
and for at least 3 weeks after the last dose. IBRANCE
may impair fertility in males and has the
potential to cause genotoxicity. Advise male patients with female
partners of reproductive potential to use effective contraception
during IBRANCE treatment and for 3 months after the last dose.
Advise females to inform their healthcare provider of a known or
suspected pregnancy. Advise women not to
breastfeed during IBRANCE treatment and for 3 weeks after
the last dose because of the potential for serious adverse
reactions in nursing infants.
The most common adverse
reactions (≥10%) of any grade reported
in PALOMA-2 for IBRANCE plus letrozole vs placebo
plus letrozole were neutropenia (80% vs 6%), infections (60% vs
42%), leukopenia (39% vs 2%), fatigue (37% vs 28%), nausea (35% vs
26%), alopecia (33% vs 16%), stomatitis (30% vs 14%), diarrhea (26%
vs 19%), anemia (24% vs 9%), rash (18% vs 12%), asthenia (17% vs
12%), thrombocytopenia (16% vs 1%), vomiting (16% vs 17%),
decreased appetite (15% vs 9%), dry skin (12% vs 6%), pyrexia (12%
vs 9%), and dysgeusia (10% vs 5%).
The most frequently reported Grade ≥3 adverse reactions
(≥5%) in PALOMA-2 for IBRANCE plus
letrozole vs placebo plus letrozole were neutropenia (66% vs 2%),
leukopenia (25% vs 0%), infections (7% vs 3%), and anemia (5% vs
2%).
Lab abnormalities of any grade occurring
in PALOMA-2 for IBRANCE plus letrozole vs placebo
plus letrozole were decreased WBC (97% vs 25%), decreased
neutrophils (95% vs 20%), anemia (78% vs 42%), decreased platelets
(63% vs 14%), increased aspartate aminotransferase (52% vs 34%),
and increased alanine aminotransferase (43% vs 30%).
The most common adverse reactions (≥10%) of any
grade reported in PALOMA-3 for IBRANCE plus
fulvestrant vs placebo plus fulvestrant were neutropenia (83% vs
4%), leukopenia (53% vs 5%), infections (47% vs 31%), fatigue (41%
vs 29%), nausea (34% vs 28%), anemia (30% vs 13%), stomatitis (28%
vs 13%), diarrhea (24% vs 19%), thrombocytopenia (23% vs 0%),
vomiting (19% vs 15%), alopecia (18% vs 6%), rash (17% vs 6%),
decreased appetite (16% vs 8%), and pyrexia (13% vs 5%).
The most frequently reported Grade ≥3 adverse reactions
(≥5%) in PALOMA-3 for IBRANCE plus
fulvestrant vs placebo plus fulvestrant were neutropenia (66% vs
1%) and leukopenia (31% vs 2%).
Lab abnormalities of any grade occurring
in PALOMA-3 for IBRANCE plus fulvestrant vs
placebo plus fulvestrant were decreased WBC (99% vs 26%), decreased
neutrophils (96% vs 14%), anemia (78% vs 40%), decreased platelets
(62% vs 10%), increased aspartate aminotransferase (43% vs 48%),
and increased alanine aminotransferase (36% vs 34%).
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 CYP3A inducers. The dose
of sensitive CYP3A substrates with a narrow
therapeutic index may need to be reduced as IBRANCE may increase
their exposure.
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 22, 2017. 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
first-line treatment of patients with HR+, HER2+ metastatic 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 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 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 for the potential
new indication and whether and when drug applications may be filed
in any additional jurisdictions for IBRANCE for potential HR+/HER2-
metastatic breast cancer indications or in any jurisdictions
for any other potential indications for IBRANCE; whether and when
any such other 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,
including the potential additional 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, 2016 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 U.S. Securities and Exchange Commission
and available at www.sec.gov and www.pfizer.com.
____________________________ 1 Loibl S, Gianni, L. HER2-positive
breast cancer. Lancet. 2017; 389(10087): 2415-2429. 2 IBRANCE®
(palbociclib) Prescribing Information. New York. NY: Pfizer Inc:
2017. 3 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. 4 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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170822005290/en/
Media:Alliance Foundation Trials, LLCJane
Lanzillotti, 617
-525-7511jlanzillotti@alliancefoundationtrials.orgorPfizerSally
Beatty, 212-733-6566sally.beatty@pfizer.com
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