First-of-its-kind comparative analysis of
real-world data in the CDK 4/6 inhibitor class supports benefits of
IBRANCE combination therapy initially shown in clinical trials
Pfizer Inc. (NYSE: PFE) today announced the presentation of four
IBRANCE® (palbociclib) real-world analyses. The studies support the
effectiveness of IBRANCE combination therapy in everyday clinical
practice and provide additional insights on its use in certain
patients with hormone receptor-positive (HR+), human epidermal
growth factor receptor 2-negative (HER2-) metastatic breast cancer
(MBC). The posters will be presented at the European Society for
Medical Oncology (ESMO) Congress 2019 in Barcelona, Spain on
Sunday, September 29.
Among the data, Pfizer will share the first real-world
comparative analysis of a CDK 4/6 inhibitor in combination with an
aromatase inhibitor compared to an aromatase inhibitor alone.
“We have an opportunity to make positive changes in cancer care
by incorporating learnings from real-world data in addition to data
gathered from clinical trials,” said Chris Boshoff, M.D., Ph.D.,
Chief Development Officer, Oncology, Pfizer Global Product
Development. “We are pleased to share this view of the impact
IBRANCE has had on patients treated outside of traditional clinical
studies, as it continues to add to the body of evidence for IBRANCE
and provides insights into the patient experience.”
About the Real-World Comparative Analysis
In this retrospective analysis (Abstract #329P: Comparative
effectiveness of palbociclib plus letrozole vs. letrozole for
metastatic breast cancer in U.S. real-world clinical
practices), treatment with IBRANCE plus letrozole demonstrated
a statistically significant improvement in real-world
progression-free survival (rwPFS) compared to letrozole alone: 24.5
months (95% CI = 20.7 – 32.7) versus 17.1 months (95% CI = 13.7 –
19.8) (HR = 0.68, 95% CI = 0.56 – 0.84, p = 0.0003).
“To help deliver the best care to our patients, it is critical
that physicians have compelling evidence of a medicine’s benefit on
patients who resemble those who they treat every day,” said Rachel
Layman, M.D., Associate Professor, Department of Breast Medical
Oncology at The University of Texas MD Anderson Cancer Center. “The
real-world evidence presented at ESMO provides a more robust
understanding of the effectiveness of IBRANCE in patients who may
not be reflected in the randomized trials.”
The analysis compared 906 matched patients with HR+, HER2- MBC
who started IBRANCE plus letrozole as initial endocrine-based
therapy in the metastatic setting (n=453) or letrozole alone
(n=453) from February 2015 to August 2018. rwPFS was measured by
the treating physician’s clinical assessment of source evidence,
such as radiographic scans or pathology from the Flatiron Health
longitudinal database. The most recent update for this database
includes de-identified electronic health records from more than 280
cancer clinics representing more than 2.2 million cancer patients
in the U.S.
The additional real-world posters at ESMO examining the use of
IBRANCE in patients with HR+, HER2- MBC are:
- Abstract #327P: Palbociclib plus an aromatase
inhibitor as first-line therapy for metastatic breast cancer in
U.S. clinical practices: Real-world progression-free survival
analysis
- This single-arm analysis of real-world disease progression and
overall survival rates in patients treated with IBRANCE plus an
aromatase inhibitor (AI), also from the Flatiron database, examined
the use of IBRANCE combination therapy as initial treatment for
patients with HR+, HER2- MBC.
- Abstract #338P: Real-world effectiveness of
first-line palbociclib + letrozole for metastatic breast cancer 4
years post approval in the U.S.
- An analysis of clinical effectiveness of IBRANCE plus letrozole
in patients who began treatment on or after February 2015, using
the Cardinal Health Oncology Provider Extended Network.
- Abstract #365P: Measures of functional status in
adults aged >70 years with advanced
breast cancer receiving palbociclib combination therapy in
POLARIS
- A subgroup analysis from the ongoing prospective, observational
POLARIS study provides insights into the use of IBRANCE in
geriatric patients (age 70 or older) treated in everyday clinical
practice – a population for which limited data are available.
To further educate the global oncology community about the
importance of real-world data at ESMO, Pfizer is sponsoring a
satellite symposium, Real World Data in Oncology: Its Growing Role
in Research and Patient Care. The symposium will take place on
Friday, September 27, from 6:00 – 8:00 pm CEST at Fira Gran Via in
the Alicante Auditorium (Hall 3).
About IBRANCE® (palbociclib) 125 mg capsules
IBRANCE is an oral inhibitor of CDKs 4 and 6,1 which are key
regulators of the cell cycle that trigger cellular progression.2,3
In the U.S., IBRANCE is indicated for the treatment of adult
patients with hormone receptor-positive (HR+), human epidermal
growth factor receptor 2-negative (HER2-)advanced or metastatic
breast cancer in combination with an aromatase inhibitor as initial
endocrine based therapy in postmenopausal women or in men; or with
fulvestrant in patients with disease progression following
endocrine therapy.
The most common adverse reactions (incidence ≥10%) associated
with IBRANCE are neutropenia, infections, leukopenia, fatigue,
nausea, stomatitis, anemia, alopecia, diarrhea, thrombocytopenia,
rash, vomiting, decreased appetite, asthenia, and pyrexia. Today in
the U.S., IBRANCE is the most prescribed FDA-approved oral
combination treatment for HR+, HER2- metastatic breast cancer.
IBRANCE currently is approved in more than 90 countries and has
been prescribed to more than 230,000 patients globally.
The full U.S. Prescribing Information for IBRANCE can be found
here.
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.
Severe, life-threatening, or fatal interstitial lung disease
(ILD) and/or pneumonitis can occur in patients treated with
CDK4/6 inhibitors, including IBRANCE when taken in combination with
endocrine therapy. Across clinical trials (PALOMA-1, PALOMA-2,
PALOMA-3), 1.0% of IBRANCE-treated patients had ILD/pneumonitis of
any grade, 0.1% had Grade 3 or 4, and no fatal cases were reported.
Additional cases of ILD/pneumonitis have been observed in the
post-marketing setting, with fatalities reported.
Monitor patients for pulmonary symptoms indicative of
ILD/pneumonitis (e.g. hypoxia, cough, dyspnea). In patients who
have new or worsening respiratory symptoms and are suspected to
have developed pneumonitis, interrupt IBRANCE immediately and
evaluate the patient. Permanently discontinue IBRANCE in patients
with severe ILD or pneumonitis.
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
to consider sperm preservation before taking IBRANCE. 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. 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.
For patients with severe hepatic impairment (Child-Pugh
class C), the recommended dose of IBRANCE is 75 mg. The
pharmacokinetics of IBRANCE have not been studied in
patients requiring hemodialysis.
About Pfizer Oncology
At Pfizer Oncology, we are committed to advancing medicines
wherever we believe we can make a meaningful difference in the
lives of patients. Today, Pfizer Oncology has an industry-leading
portfolio of 22 approved innovative cancer medicines and
biosimilars across more than 30 indications, including breast,
prostate, kidney and lung cancers, as well as leukemia and
melanoma. Pfizer Oncology is striving to change the trajectory of
cancer.
Pfizer Inc.: Breakthroughs that change patients’
lives
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, including innovative medicines and vaccines. 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
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providers, governments and local communities to support and expand
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who rely on us. We routinely post information that may be important
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DISCLOSURE NOTICE: The information contained in this release is
as of September 24, 2019. 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 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 endpoints, commencement and/or
completion dates for our clinical trials, regulatory submission
dates, regulatory approval dates and/or launch dates, as well as
the possibility of unfavorable new clinical data and further
analyses of existing clinical data; the risk that clinical trial
data are subject to differing interpretations and assessments by
regulatory authorities; 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 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 myriad factors, including making a determination as to
whether the product's benefits outweigh its known risks and
determination of the product's efficacy and, if approved, whether
such product candidates will be commercially successful; decisions
by regulatory authorities impacting labeling, manufacturing
processes, safety and/or 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, 2018 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 IBRANCE® (palbociclib)
Prescribing Information. New York. NY: Pfizer Inc: 2019. 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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