IBRANCE is the first CDK4/6 inhibitor to show
benefit in a large Phase 3 trial in first-line HR+, HER2+
metastatic breast cancer, in combination with anti-HER2 and
endocrine therapy
Pfizer Inc. (NYSE:PFE) and Alliance Foundation Trials, LLC (AFT)
today announced results from the Phase 3 PATINA trial demonstrating
that the addition of IBRANCE® (palbociclib) to current
standard-of-care first-line maintenance therapy (following
induction chemotherapy) resulted in statistically significant and
clinically meaningful improvement in progression-free survival
(PFS) by investigator assessment in patients with hormone
receptor-positive (HR+), human epidermal growth factor receptor
2-positive (HER2+) metastatic breast cancer (MBC). In the study,
which is sponsored by AFT, median PFS was 44.3 months (95% CI:
32.4-60.9) for patients treated with IBRANCE in combination with
anti-HER2 therapy (trastuzumab or trastuzumab plus pertuzumab) and
endocrine therapy, and 29.1 months (95% CI: 23.3-38.6) for patients
treated with anti-HER2 therapy and endocrine therapy alone [HR:
0.74 (95% CI, 0.58-0.94); unstratified 1-sided p= 0.0074]. This
represents an extension in median PFS of over 15 months. Overall
survival, a secondary endpoint, was not yet mature at the time of
the analysis. These results are being presented during a
late-breaking oral session (Abstract GS2-12) and highlighted in the
press program at the 47th San Antonio Breast Cancer Symposium
(SABCS) in San Antonio, Texas.
“PATINA is the first large Phase 3 study to show the benefit of
CDK4/6 inhibition in HR-positive, HER2-positive metastatic breast
cancer,” said Otto Metzger, M.D., principal investigator of the
trial for Alliance Foundation Trials and Medical Oncologist at the
Dana-Farber Cancer Institute. “These results support the potential
of this maintenance treatment to slow disease progression and
improve clinical outcomes in this patient population.”
Approximately 10% of all breast cancers are HR+, HER2+i, which
is sometimes referred to as double-positive or triple-positive
breast cancer. Despite advances in treatment, the development of
resistance to anti-HER2 and endocrine therapy is a challenge, and
novel therapeutic approaches are needed for HR+, HER2+ MBC.ii
IBRANCE is not currently indicated for HR+, HER2+ MBC.
“IBRANCE, the first CDK4/6 inhibitor, revolutionized the
treatment of HR-positive, HER2-negative metastatic breast cancer,
and has been prescribed to over 773,000 patients since its initial
approval in 2015,” said Roger Dansey, M.D., Chief Development
Officer, Oncology, Pfizer. “These results demonstrate that the
addition of IBRANCE to standard of care shows promise as
maintenance therapy in HR-positive, HER2-positive disease. PATINA
underscores Pfizer’s ongoing commitment to addressing the unmet
needs of people with breast cancer, and we look forward to
discussing the results with regulatory authorities.”
The safety and tolerability of IBRANCE in the PATINA study was
consistent with its known safety profile in HR+, human epidermal
growth factor receptor 2-negative (HER2-) MBC, and no new safety
signals were identified. The most common adverse events observed
with IBRANCE were hematologic toxicities, such as neutropenia and
leukopenia. Non-hematologic adverse events included fatigue,
stomatitis and diarrhea, which were generally mild to moderate in
severity.
Since its initial regulatory approval in 2015, IBRANCE continues
to be a standard-of-care first-line treatment for HR+, HER2- MBC
and has been approved in more than 108 countries. Pfizer plans to
share the results from PATINA with regulatory authorities.
About the PATINA Trial PATINA (AFT-38) is a randomized,
open-label Phase 3 study to evaluate the efficacy and safety of
IBRANCE® (palbociclib) in combination with anti-HER2 therapy
(trastuzumab or trastuzumab plus pertuzumab) and endocrine therapy
compared to anti-HER2 therapy and endocrine therapy alone as a
first-line maintenance therapy (following induction chemotherapy
treatment) for patients with hormone receptor-positive (HR+), human
epidermal growth factor receptor 2-positive (HER2+) metastatic
breast cancer (MBC). While Pfizer is providing funding support for
the trial, PATINA is sponsored by Alliance Foundation Trials, LLC
(AFT) in collaboration with six international cancer research
groups in the U.S., Germany, Italy, Spain, Australia, and New
Zealand.
Study participants who were previously treated with anti-HER2
therapy were randomized to receive IBRANCE, in addition to
anti-HER2 therapy and endocrine therapy (n=261), or anti-HER2
therapy and endocrine therapy alone (n=257). The primary endpoint
is progression-free survival (PFS) as assessed by the investigator.
Overall survival is a secondary endpoint.
About IBRANCE® (palbociclib) IBRANCE is an oral inhibitor
of CDKs 4 and 6,iii which are key regulators of the cell cycle that
trigger cellular progression.iv,v In the U.S., IBRANCE is indicated
for the treatment of adult patients with HR+, 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 full U.S. Prescribing Information for the IBRANCE tablets
and the IBRANCE capsules can be found here and 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 Alliance Foundation Trials (AFT) Alliance
Foundation Trials, LLC (AFT) is a research organization that
develops and conducts cancer clinical trials, working closely with
the Alliance for Clinical Trials in Oncology (Alliance) scientific
investigators, and its institutional member network, research
collaborators, and non-NCI funding sources. AFT seeks to fulfill a
shared vision with Alliance 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. Current AFT studies are funded by industry collaborators
and the Patient-Centered Outcomes Research Institute (PCORI). For
more information about AFT, please visit
www.AllianceFoundationTrials.org.
About Pfizer Oncology At Pfizer Oncology, we are at the
forefront of a new era in cancer care. Our industry-leading
portfolio and extensive pipeline includes three core mechanisms of
action to attack cancer from multiple angles, including small
molecules, antibody-drug conjugates (ADCs), and bispecific
antibodies, including other immune-oncology biologics. We are
focused on delivering transformative therapies in some of the
world’s most common cancers, including breast cancer, genitourinary
cancer, hematology-oncology, and thoracic cancers, which includes
lung cancer. Driven by science, we are committed to accelerating
breakthroughs to help people with cancer live better and longer
lives.
About Pfizer: 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
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
175 years, we have worked to make a difference for all who rely on
us. We routinely post information that may be important to
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more, please visit us on www.Pfizer.com and follow us on X at
@Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook
at Facebook.com/Pfizer.
Pfizer Disclosure Notice The information contained in
this release is as of December 12, 2024. 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 Pfizer
Oncology and IBRANCE® (palbociclib), including its potential
benefits and results from the Phase 3 PATINA trial in patients with
HR+, HER2+ metastatic breast cancer, 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; whether the PATINA trial will meet the
secondary endpoint for overall survival; 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 any drug applications may be filed in any
jurisdictions for IBRANCE for HR+, HER2+ metastatic breast cancer
or any other potential indications; whether and when any such
applications may be approved by regulatory authorities, which will
depend on a 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
IBRANCE 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; uncertainties regarding the impact
of COVID-19 on Pfizer’s business, operations and financial results;
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, 2023, 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.
_______________________________ i National Cancer Institute.
Cancer Stat Facts: Female Breast Cancer Subtypes.
https://seer.cancer.gov/statfacts/html/breast-subtypes.html#:~:text=Percent%20of%20Female,Unknown%20(6%25).
Accessed December 2024. ii Nature. Estrogen/HER2 receptor crosstalk
in breast cancer: combination therapies to improve outcomes for
patients with hormone receptor-positive/HER2-positive breast cancer
iii IBRANCE (palbociclib) Prescribing Information. New York. NY:
Pfizer Inc: 2023. iv 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. v 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.
Category: Medicines
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