More than 40 accepted abstracts highlight
innovation in immuno-oncology and other novel modalities across
multiple tumor types
Pfizer invites public to view and listen to
webcast of conference call with analysts on Wednesday, June 8 at 10
a.m. EDT to review oncology business and ASCO data
presentations
Pfizer Inc. (NYSE:PFE) today announced that the company will
have its largest presence to date at the 52nd Annual Meeting of the
American Society of Clinical Oncology (ASCO) in Chicago from June
3-7, with more than 40 abstracts spanning a diverse and growing
portfolio seeking to tackle numerous cancers and mechanisms of
action. Presentations include eight oral presentations and five
poster discussions that span Pfizer’s internal and collaborative
scientific advances. Highlights include the first presentation of a
novel immunotherapy combination study involving a 4-1BB agonist and
checkpoint inhibitor as a potential new immunotherapy strategy and
new clinical data featuring breakthrough treatments IBRANCE®
(palbociclib) and XALKORI® (crizotinib), as well as investigational
assets avelumab, an anti-PD-L1 IgG1 monoclonal antibody that is
being developed in collaboration with Merck KGaA, Darmstadt,
Germany, and lorlatinib, a next-generation ALK/ROS1 tyrosine kinase
inhibitor.
“Our significant presence at ASCO underscores our long-term
commitment to oncology, cutting-edge science and the strength of
collaborations to help bring forward potential new medicines that
address the serious and complex needs of people battling cancer,”
said Liz Barrett, global president and general manager, Pfizer
Oncology. “We look forward to sharing our findings with the entire
oncology community with the hope that our collective efforts will
continue to advance innovative approaches and redefine life with
cancer.”
Immuno-Oncology Highlights
New clinical data from Pfizer’s growing immuno-oncology
portfolio features an oral presentation on utomilumab (the proposed
generic name for PF-05082566), Pfizer’s novel 4-1BB agonist, in
combination with pembrolizumab, a PD-1 inhibitor, in patients with
a variety of advanced solid tumors. Numerous other presentations
offer new insights from the JAVELIN clinical development program of
avelumab, the proposed nonproprietary name for the anti-PD-L1 mAb
(also known as MSB0010718C), including new data from the
registrational, Phase 2 trial in second-line metastatic Merkel cell
carcinoma (MCC).
“Immunotherapy is revolutionizing the treatment of cancer, and
Pfizer is advancing a diverse immuno-oncology pipeline with promise
for patients with numerous types of cancer,” said Chris Boshoff,
vice president and head of early development, translational and
immuno-oncology for Pfizer Oncology.
Key oral immuno-oncology presentations include:
- Phase 1b study of PF-05082566 in
combination with pembrolizumab in patients with advanced solid
tumors (Tolcher et al)
- Avelumab (MSB0010718C; anti-PD-L1) in
patients with metastatic Merkel cell carcinoma previously treated
with chemotherapy: Results of the Phase 2 JAVELIN Merkel 200 trial
(Kaufman et al)
- Avelumab (MSB0010718C; anti-PD-L1) in
patients with advanced unresectable mesothelioma from the JAVELIN
solid tumor phase 1b trial: Safety, clinical activity, and PD-L1
expression (Hassan et al)
Breast Cancer Highlights
IBRANCE data to be presented at ASCO demonstrate Pfizer’s
continued leadership in breast cancer and add to the growing body
of knowledge around this first-in-class CDK 4/6 inhibitor in
metastatic breast cancer. Since its FDA approval in February 2015,
more than 28,000 women have been prescribed IBRANCE by more than
6,800 prescribers in the U.S. IBRANCE is the only CDK 4/6 inhibitor
with Phase 3 data in this disease. New Phase 3 PALOMA-2 data to be
presented at ASCO represent the third randomized pivotal study of
IBRANCE in combination with endocrine therapy to demonstrate
clinical benefit for women with HR+, HER2- metastatic breast
cancer.
Key abstracts include:
- PALOMA-2: Primary results from a phase
III trial of palbociclib with letrozole compared with letrozole
alone in postmenopausal women with ER+/HER2- advanced breast cancer
(Finn et al)
- Efficacy of palbociclib plus
fulvestrant in patients with metastatic breast cancer and ESR1
mutations in circulating tumor DNA (Turner at al)
Lung Cancer Highlights
Pfizer’s continuing leadership in biomarker-driven treatments
for lung cancer will be represented by new data on XALKORI and
next-generation investigational treatment lorlatinib, the proposed
generic name for PF-06463922.
Key abstracts include:
- Safety and efficacy of lorlatinib
(PF-06463922) from the dose-escalation component of a study in
patients with advanced ALK+ or ROS1+ non-small cell lung cancer
(Solomon et al)
- Phase II study of crizotinib in East
Asian patients with ROS1-positive advanced non-small cell lung
cancer (Goto et al)
- Efficacy and safety of crizotinib in
patients with advanced MET Exon 14-altered non-small cell lung
cancer (Drilon et al)
Pfizer Oral Presentation Planner
Title/Abstract Number Date/Time (CDT)
Location (Abstract 512) Efficacy of palbociclib plus
fulvestrant (P+F) in patients with metastatic breast cancer and
ESR1 mutations in circulating tumor DNA
Turner N
Friday, June 3
5:18 – 5:30 p.m.
Hall D1
(Abstract 3002) Phase 1b study of PF-05082566 in
combination with pembrolizumab in patients with advanced solid
tumors
Tolcher A
Saturday, June 4
1:39 – 1:51 p.m.
Hall B1
(Abstract 8503) Avelumab* (MSB0010718C;
anti-PD-L1) in patients with advanced unresectable mesothelioma
from the JAVELIN solid tumor phase 1b trial: Safety, clinical
activity, and PD-L1 expression
Hassan R
Sunday, June 5
8:58 – 9:10 a.m.
Arie Crown Theater
(Abstract 11509) Crizotinib in
children and adolescents with advanced ROS1, MET, or ALK-rearranged
cancer: Results of the AcSé phase II trial
Vassal G
Monday, June 6
9:45 – 9:57 a.m.
S404
(Abstract 108) Efficacy and safety of crizotinib in
patients with advanced MET Exon 14-altered non-small cell lung
cancer
Drilon A
Monday, June 6
10:09 – 10:21 a.m.
Hall D1
(Abstract 9009) Safety and efficacy of lorlatinib
(PF-06463922) from the dose-escalation component of a study in
patients with advanced ALK+ or ROS1+ non-small cell lung cancer
Solomon B
Monday, June 6
1:15 – 1:27 p.m.
Hall D2
(Abstract 507)
PALOMA-2: Primary results from a phase
III trial of palbociclib with letrozole compared with letrozole
alone in postmenopausal women with ER+/HER2- advanced breast
cancer
Slamon D
Monday, June 6
3:27 – 3:39 pm
Hall D1
(Abstract 9508)
Avelumab* (MSB0010718C; anti-PD-L1) in
patients with metastatic Merkel cell carcinoma previously treated
with chemotherapy: Results of the phase 2 JAVELIN Merkel 200
trial
Kaufman H
Monday, June 6
3:39 – 3:51 p.m.
Arie Crown Theater
* Avelumab is being developed through an alliance between Merck
KGaA, Darmstadt, Germany, and Pfizer
For a complete list of Pfizer-sponsored abstracts featuring data
on our broad pipeline of biologics and small molecules, please
visit:
http://www.pfizer.com/files/news/asco/ASCO2016_FactSheet_PfizerOncologyDataPresentations2016.pdf
Learn more about how Pfizer Oncology is applying innovative
approaches to improve the outlook for people living with cancer at
http://www.pfizer.com/research/therapeutic_areas/oncology.
Post-ASCO Analyst Conference Call
Pfizer invites investors and the general public to view and
listen to a webcast of a conference call with investment analysts
on Wednesday, June 8, 2016 at 10 a.m. EDT to review Pfizer’s
oncology business and ASCO data presentations.
To pre-register for and access the webcast and conference call,
please visit the For Investors section of www.pfizer.com. You can
also listen to the conference call by dialing (855) 895-8759 in the
United States and Canada or (503) 343-6044 in other countries. The
password is ASCO. The webcast will be archived on
www.pfizer.com.
About IBRANCE® (palbociclib) 125mg
capsules
IBRANCE is an oral inhibitor of CDKs 4 and 6,i which are key
regulators of the cell cycle that trigger cellular
progression.ii,iii IBRANCE is indicated for the treatment of HR+,
HER2- advanced or metastatic breast cancer in combination with
letrozole as initial endocrine based therapy in postmenopausal
women, or fulvestrant in women with disease progression following
endocrine therapy.i The indication in combination with letrozole is
approved under accelerated approval based on progression-free
survival (PFS). Continued approval for this indication may be
contingent upon verification and description of clinical benefit in
a confirmatory trial.i
IBRANCE Important Safety Information
Neutropenia was the most frequently reported adverse
reaction in Study 1 (PALOMA-1) (75%) and Study 2 (PALOMA-3) (83%).
In Study 1, Grade 3 (57%) or 4 (5%) decreased neutrophil counts
were reported in patients receiving IBRANCE plus letrozole. In
Study 2, Grade 3 (56%) or Grade 4 (11%) decreased neutrophil counts
were reported in patients receiving IBRANCE plus fulvestrant.
Febrile neutropenia has been reported in about 1% of patients
exposed to IBRANCE. One death due to neutropenic sepsis was
observed in Study 2. Inform patients to promptly report any
fever.
Monitor complete blood count prior to starting IBRANCE, at the
beginning of each cycle, on Day 14 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.
Pulmonary embolism (PE) has been reported at a higher
rate in patients treated with IBRANCE plus letrozole in Study 1
(5%) and in patients treated with IBRANCE plus fulvestrant in Study
2 (1%) compared with no cases in patients treated either with
letrozole alone or fulvestrant plus placebo. Monitor for signs and
symptoms of PE and treat as medically appropriate.
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 Study 1 of IBRANCE plus letrozole vs
letrozole alone 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 (≥10%) in Study 1
reported at a higher incidence in the IBRANCE plus letrozole group
vs the letrozole alone group included neutropenia (54% vs 1%) and
leukopenia (19% vs 0%). The most frequently reported serious
adverse events in patients receiving IBRANCE plus letrozole were
pulmonary embolism (4%) and diarrhea (2%).
Lab abnormalities occurring in Study 1 (all
grades, IBRANCE plus letrozole vs letrozole alone) were decreased
WBC (95% vs 26%), decreased neutrophils (94% vs 17%), decreased
lymphocytes (81% vs 35%), decreased hemoglobin (83% vs 40%), and
decreased platelets (61% vs 16%).
The most common adverse reactions (≥10%) of any grade
reported in Study 2 of IBRANCE plus fulvestrant vs
fulvestrant plus placebo included 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%), headache (26% vs 20%), diarrhea (24% vs 19%),
thrombocytopenia (23% vs 0%), constipation (20% vs 16%), vomiting
(19% vs 15%), alopecia (18% vs 6%), rash (17% vs 6%), decreased
appetite (16% vs 8%), and pyrexia (13% vs 5%).
Grade 3/4 adverse reactions (≥10%) in Study 2
reported at a higher incidence in the IBRANCE plus fulvestrant
group vs the fulvestrant plus placebo group included neutropenia
(66% vs 1%) and leukopenia (31% vs 2%). The most frequently
reported serious adverse reactions in patients receiving IBRANCE
plus fulvestrant were infections (3%), pyrexia (1%), neutropenia
(1%), and pulmonary embolism (1%).
Lab abnormalities occurring in Study 2 (all
grades, IBRANCE plus fulvestrant vs fulvestrant plus placebo) were
decreased WBC (99% vs 26%), decreased neutrophils (96% vs 14%),
anemia (78% vs 40%), and decreased platelets (62% vs 10%).
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).
The full prescribing information for IBRANCE can be found at
www.pfizer.com.
About XALKORI® (crizotinib)
XALKORI is a kinase inhibitor indicated in the U.S. for the
treatment of patients with metastatic non-small cell lung cancer
(NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive
as detected by an FDA-approved test, and for the treatment of
patients with metastatic NSCLC whose tumors are ROS1-positive.
XALKORI was the first ALK inhibitor approved in the U.S. and has
been used to treat more than 8,000 patients to date.iv
XALKORI Important Safety Information
Hepatotoxicity: Drug-induced hepatotoxicity with fatal
outcome occurred in 0.1% of patients treated with XALKORI across
clinical trials (n=1719). Transaminase elevations generally
occurred within the first 2 months. Monitor with liver function
tests including ALT, AST, and total bilirubin every 2 weeks during
the first 2 months of treatment, then once a month and as
clinically indicated, with more frequent repeat testing for
increased liver transaminases, alkaline phosphatase, or total
bilirubin in patients who develop transaminase elevations.
Permanently discontinue for ALT/AST elevation >3 times ULN with
concurrent total bilirubin elevation >1.5 times ULN (in the
absence of cholestasis or hemolysis); otherwise, temporarily
suspend and dose-reduce XALKORI as indicated.
Interstitial Lung Disease (Pneumonitis): Severe,
life-threatening, or fatal interstitial lung disease
(ILD)/pneumonitis can occur. Across clinical trials (n=1719), 2.9%
of XALKORI-treated patients had any grade ILD, 1.0% had Grade 3/4,
and 0.5% had fatal ILD. ILD generally occurred within 3 months
after initiation of treatment. Monitor for pulmonary symptoms
indicative of ILD/pneumonitis. Exclude other potential causes and
permanently discontinue XALKORI in patients with drug-related
ILD/pneumonitis.
QT Interval Prolongation: QTc prolongation can occur.
Across clinical trials (n=1616), 2.1% of patients had QTcF
(corrected QT by the Fridericia method) ≥500 ms and 5.0% had an
increase from baseline QTcF ≥60 ms by automated machine-read
evaluation of ECGs. Avoid use in patients with congenital long QT
syndrome. Monitor with ECGs and electrolytes in patients with
congestive heart failure, bradyarrhythmias, electrolyte
abnormalities, or who are taking medications that prolong the QT
interval. Permanently discontinue XALKORI in patients who develop
QTc >500 ms or ≥60 ms change from baseline with Torsade de
pointes, polymorphic ventricular tachycardia, or signs/symptoms of
serious arrhythmia. Withhold XALKORI in patients who develop QTc
>500 ms on at least 2 separate ECGs until recovery to a QTc ≤480
ms, then resume at a reduced dose.
Bradycardia: Symptomatic bradycardia can occur. Across
clinical trials, bradycardia occurred in 12.7% of patients treated
with XALKORI (n=1719). Avoid use in combination with other agents
known to cause bradycardia. Monitor heart rate and blood pressure
regularly. In cases of symptomatic bradycardia that is not
life-threatening, hold XALKORI until recovery to asymptomatic
bradycardia or to a heart rate of ≥60 bpm, re-evaluate the use of
concomitant medications, and adjust the dose of XALKORI.
Permanently discontinue for life-threatening bradycardia due to
XALKORI; however, if associated with concomitant medications known
to cause bradycardia or hypotension, hold XALKORI until recovery to
asymptomatic bradycardia or to a heart rate of ≥60 bpm. If
concomitant medications can be adjusted or discontinued, restart
XALKORI at 250 mg once daily with frequent monitoring.
Severe Visual Loss: Across clinical trials, the incidence
of Grade 4 visual field defect with vision loss was 0.2% (n=1719).
Discontinue XALKORI in patients with new onset of severe visual
loss (best corrected vision less than 20/200 in one or both eyes).
Perform an ophthalmological evaluation. There is insufficient
information to characterize the risks of resumption of XALKORI in
patients with a severe visual loss; a decision to resume should
consider the potential benefits to the patient.
Vision Disorders: Most commonly visual impairment,
photopsia, blurred vision or vitreous floaters, occurred in 63.1%
of 1719 patients. The majority (95%) of these patients had Grade 1
visual adverse reactions. 0.8% of patients had Grade 3 and 0.2% had
Grade 4 visual impairment. The majority of patients on the XALKORI
arms in Studies 1 and 2 (>50%) reported visual disturbances
which occurred at a frequency of 4-7 days each week, lasted up to 1
minute, and had mild or no impact on daily activities.
Embryo-Fetal Toxicity: XALKORI can cause fetal harm when
administered to a pregnant woman. Advise of the potential risk to
the fetus. Advise females of reproductive potential and males with
female partners of reproductive potential to use effective
contraception during treatment and for at least 45 days (females)
or 90 days (males) respectively, following the final dose of
XALKORI.
ROS1-positive Metastatic NSCLC: Safety was evaluated in
50 patients with ROS1-positive metastatic NSCLC from a single-arm
study, and was generally consistent with the safety profile of
XALKORI evaluated in patients with ALK-positive metastatic NSCLC.
Vision disorders occurred in 92% of patients in the ROS1 study; 90%
of patients had Grade 1 vision disorders and 2% had Grade 2.
Adverse Reactions: Safety was evaluated in a phase 3
study in previously untreated patients with ALK-positive metastatic
NSCLC randomized to XALKORI (n=171) or chemotherapy (n=169).
Serious adverse events were reported in 34% of patients treated
with XALKORI, the most frequent were dyspnea (4.1%) and pulmonary
embolism (2.9%). Fatal adverse events in XALKORI-treated patients
occurred in 2.3% of patients, consisting of septic shock, acute
respiratory failure, and diabetic ketoacidosis. Common adverse
reactions (all grades) occurring in ≥25% and more commonly (≥5%) in
patients treated with XALKORI vs chemotherapy were vision disorder
(71% vs 10%), diarrhea (61% vs 13%), edema (49% vs 12%), vomiting
(46% vs 36%), constipation (43% vs 30%), upper respiratory
infection (32% vs 12%), dysgeusia (26% vs 5%), and abdominal pain
(26% vs 12%). Grade 3/4 reactions occurring at a ≥2% higher
incidence with XALKORI vs chemotherapy were QT prolongation (2% vs
0%), and constipation (2% vs 0%). In patients treated with XALKORI
vs chemotherapy, the following occurred: elevation of ALT (any
grade [79% vs 33%] or Grade 3/4 [15% vs 2%]); elevation of AST (any
grade [66% vs 28%] or Grade 3/4 [8% vs 1%]); neutropenia (any grade
[52% vs 59%] or Grade 3/4 [11% vs 16%]); lymphopenia (any grade
[48% vs 53%] or Grade 3/4 [7% vs 13%]); hypophosphatemia (any grade
[32% vs 21%] or Grade 3/4 [10% vs 6%]). In patients treated with
XALKORI vs chemotherapy, renal cysts occurred (5% vs 1%). Nausea
(56%), decreased appetite (30%), fatigue (29%), and neuropathy
(21%) also occurred in patients taking XALKORI.
Drug Interactions: Exercise caution with concomitant use
of moderate CYP3A inhibitors. Avoid grapefruit or grapefruit juice
which may increase plasma concentrations of crizotinib. Avoid
concomitant use of strong CYP3A inducers and inhibitors. Avoid
concomitant use of CYP3A substrates with narrow therapeutic range
in patients taking XALKORI. If concomitant use of CYP3A substrates
with narrow therapeutic range is required in patients taking
XALKORI, dose reductions of the CYP3A substrates may be required
due to adverse reactions.
Lactation: Because of the potential for adverse reactions
in breastfed infants, advise females not to breast feed during
treatment with XALKORI and for 45 days after the final dose.
Hepatic Impairment: XALKORI has not been studied in
patients with hepatic impairment. As crizotinib is extensively
metabolized in the liver, hepatic impairment is likely to increase
plasma crizotinib concentrations. Use caution in patients with
hepatic impairment.
Renal Impairment: Decreases in estimated glomerular
filtration rate occurred in patients treated with XALKORI.
Administer XALKORI at a starting dose of 250 mg taken orally once
daily in patients with severe renal impairment (CLcr <30 mL/min)
not requiring dialysis. No starting dose adjustment is needed for
patients with mild and moderate renal impairment.
For more information and full Prescribing Information, visit
www.XALKORI.com.
About Pfizer Oncology
Pfizer Oncology is committed to the discovery, investigation and
development of innovative treatment options to improve the outlook
for 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, please visit www.Pfizer.com.
Pfizer Inc.: Working together for a healthier
worldTM
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 healthcare
products. Our global portfolio includes medicines and vaccines as
well as many of the world's best-known consumer healthcare
products. 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, Pfizer has worked to make a difference for
all who rely on us. For more information, please visit us at
www.pfizer.com. In addition, to learn more, 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 18, 2016. 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’s
oncology portfolio, including utomilumab (PF-05082566), avelumab
(MSB0010718C), IBRANCE (palbociclib), Xalkori (crizotinib) and
lorlatinib (PF-06463922), the potential of immuno-oncology and
clinical development plans, including their 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 Pfizer’s
oncology products; the uncertainties inherent in research and
development, including the ability to meet anticipated clinical
study commencement and completion dates as well as the possibility
of unfavorable study results, including unfavorable new clinical
data and additional analyses of existing clinical data; risks
associated with interim data; the risk that clinical trial data are
subject to differing interpretations, and, even when we view data
as sufficient to support the safety and/or effectiveness of a
product candidate, regulatory authorities may not share our views
and may require additional data or may deny approval altogether;
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 any potential
indications for Pfizer’s oncology products and product candidates;
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 Pfizer’s oncology products and product candidates; 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, 2015 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 IBRANCE® (palbociclib) Prescribing Information. New York. NY:
Pfizer Inc: 2016.
ii 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.
iii 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.
iv Pfizer. Data on file.
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