As announced today by the Austrian Breast & Colorectal
Cancer Study Group and the Alliance Foundation Trials, LLC, Pfizer
Inc. (NYSE: PFE) reports that following a preplanned efficacy and
futility analysis, the independent Data Monitoring Committee (DMC)
of the collaborative Phase 3 early breast cancer PALbociclib
CoLlaborative Adjuvant Study (PALLAS)
determined that the trial is unlikely to show a statistically
significant improvement in the primary endpoint of invasive
disease-free survival (iDFS). Patients currently receiving
palbociclib in the study will be advised about next steps by their
physicians and long-term follow up of all patients will proceed as
planned. No unexpected new safety signals were observed in patients
receiving palbociclib.
The PALLAS trial compares palbociclib plus standard adjuvant
endocrine therapy to standard adjuvant endocrine therapy alone in
women and men with hormone receptor-positive (HR+), human epidermal
growth factor receptor 2-negative (HER2-) early (stage 2 and 3)
breast cancer and is an academically-led global collaboration,
involving more than 400 centers in 21 countries around the
globe.
“We are disappointed in this outcome. Breast cancer is a leading
cause of death around the world and delaying or preventing the
development of metastatic disease is a significant unmet need.
PALLAS is a large study with many subgroups and we are actively
collaborating to determine if there are patients who may benefit
from adjuvant treatment with the palbociclib combination," said
Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology,
Pfizer Global Product Development. “Since its initial approval in
2015, IBRANCE has helped change the treatment landscape for people
with HR+, HER2- metastatic breast cancer. We are grateful to all
patients, health care providers and our academic partners who have
devoted so much to make this important study possible.”
“This result is not what we hoped for, but we are steadfast in
our commitment to advancing the science and care for people living
with breast cancer,” said Albert Bourla, Pfizer Chairman and CEO.
“Given the continued breadth of our marketed portfolio and strength
of our pipeline, our growth projections are not reliant upon any
individual marketed medicine or pipeline opportunity. Consequently,
we remain highly confident in our ability to deliver, following the
closing of the proposed combination of Upjohn with Mylan N.V., a
compound annual growth rate for revenues of at least 6% through
2025.”
Health authorities and trial investigators have been notified of
this decision. When available, the full results from the PALLAS
study will be shared with the scientific community at a later
date.
Palbociclib is also being studied in patients with high-risk
early breast cancer and results from the collaborative PENELOPE-B
trial are expected later this year.
In the U.S., IBRANCE is approved 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.
IBRANCE is not indicated in early breast cancer. The collaborative
Phase 3 PENELOPE-B study (NCT01864746) continues to explore the
potential of IBRANCE in patients with early breast cancer at high
risk of recurrence who have residual disease after neoadjuvant
chemotherapy.
About the PALLAS Trial
PALLAS is a randomized (1:1), prospective, international,
multicenter, open-label Phase 3 study comparing the combination of
palbociclib and standard adjuvant endocrine therapy for two years
followed by continuing standard adjuvant therapy to complete five
years versus at least five years of standard adjuvant endocrine
therapy for pre- and postmenopausal women or men with HR+, HER2-
early invasive (Stage 2 and Stage 3) breast cancer, including those
at moderate to high risk of recurrence. The trial is co-sponsored
by the Austrian Breast & Colorectal Cancer Study Group and the
Alliance Foundation Trials as part of a clinical research
collaboration with Pfizer and other study groups, including PrECOG,
LLC; NSABP Foundation Inc; and the Breast International Group
(BIG).
About IBRANCE® (palbociclib) 125 mg tablets and
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 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.
IBRANCE currently is approved in more than 95 countries and has
been prescribed to more than 300,000 patients globally.
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 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 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
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, we have worked to make a difference for all
who rely on us. We routinely post information that may be important
to investors on our website at www.pfizer.com. In addition, to
learn more, please visit us on www.pfizer.com and follow us on
Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube, and like us
on Facebook at Facebook.com/Pfizer.
DISCLOSURE NOTICE: The information contained in this release is
as of May 29, 2020. 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 and the anticipated
timing of results from the Phase 3 PENELOPE-B study, and the
Company’s projected compound annual growth rate for revenues 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;
uncertainties regarding the commercial impact of the results of the
PALLAS trial; 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 jurisdictions for IBRANCE for the
treatment of high-risk early breast cancer or in any jurisdictions
for any other potential indications for IBRANCE; whether and when
any such 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 candidate 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; the
uncertainties inherent in business and financial planning,
including, without limitation, risks related to Pfizer’s business
and prospects, adverse developments in Pfizer’s markets, or adverse
developments in the U.S. or global capital markets, credit markets,
regulatory environment or economies generally; uncertainties
regarding the impact of COVID-19 on Pfizer’s business, operations
and financial results; risks related to the parties ability to
consummate the proposed combination of Upjohn with Mylan N.V.; 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, 2019 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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Pfizer Media: Jessica Smith 212-733-6213
Jessica.M.Smith@pfizer.com Pfizer Investors: Ryan Crowe
212-733-8160 Ryan.Crowe@pfizer.com
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