First Positive Phase 3 Results in Adjuvant Setting for Renal Cell Carcinoma Show SUTENT® (sunitinib) Extended Disease Free Survival After Surgical Removal

NEW YORK–(BUSINESS WIRE)– Pfizer Inc. (NYSE:PFE) today announced results from the Phase 3 S-TRAC
clinical trial (Sunitinib Trial as Adjuvant Treatment of Renal Cancer)
investigating SUTENT^® (sunitinib) as adjuvant therapy. The
trial showed SUTENT extended disease-free survival (DFS) by more than
one year versus placebo in patients who were at high risk for recurrence
after surgical resection of renal cell carcinoma (RCC) (HR 0.761;
P=0.030 [95% CI: 0.594-0.975]). These results will be presented today
during a Presidential Symposium (Abstract #LBA11_PR) at the ESMO 2016
Congress, the annual meeting of the European Society for Medical
Oncology being held in Copenhagen, Denmark. The results have also been
published online by The New England Journal of Medicine.

Adjuvant therapies are treatments that can be given to reduce the
likelihood of the cancer returning after initial treatment such as
surgery.

“We are encouraged by the S-TRAC results because this is the first
clinical trial to show increased disease-free survival in the adjuvant
setting for RCC,” said lead investigator Alain Ravaud, M.D., Ph.D., CHU
de Bordeaux Hôpital Saint André. “These data are promising for RCC
patients as there are no effective treatments currently available in
this setting.”

The results from the S-TRAC trial showed that after one year of
treatment, the median time until disease recurrence in participants
treated with SUTENT after surgery was 6.8 years compared with 5.6 years
for patients treated with placebo as assessed by independent central
review, resulting in an overall risk reduction of 24 percent. At the
time of the analysis, overall survival (OS) data was immature.

Based on the results of S-TRAC, Pfizer is in discussions with global
regulatory authorities to determine potential next steps.

“For the past 10 years, Pfizer has been a leader in developing new
treatments for patients with kidney cancer, and SUTENT has been the most
widely prescribed first line treatment for thousands of patients with
advanced RCC around the world,” said Mace Rothenberg, MD, Chief
Development Officer, Oncology, Pfizer Global Product Development. “The
results of S-TRAC suggest that SUTENT has the potential to extend this
benefit by reducing the risk of recurrence in patients who have
undergone complete surgical removal of their kidney cancer and are at
high risk of cancer recurrence.”

The adverse events seen in the trial were consistent with SUTENT’s known
safety profile. The most common adverse reactions (>20%) are fatigue,
asthenia, and fever. Grade ≥3 adverse events were more frequent with
SUTENT (62.1%) vs. placebo (21.1%). No deaths occurred due to treatment
toxicity.

SUTENT is an oral cancer medication that was first approved in the
United States in 2006 for the treatment of advanced RCC. It is currently
approved in 119 countries.ⁱ Worldwide more than 250,000
patients across diagnoses have been treated with SUTENT in its approved
indications of advanced RCC, imatinib-resistant or -intolerant
gastrointestinal stromal tumors (GIST) and advanced pancreatic
neuroendocrine tumors (pNET).ⁱⁱ SUTENT is not approved in the
adjuvant setting.

About Renal Cell Carcinoma (RCC)

Each year, approximately 338,000 new cases of kidney cancer are
diagnosed worldwide, representing approximately 2-3 percent of all
cancers.ⁱⁱⁱ Renal cell carcinoma (RCC) is the most common
type of kidney cancer, accounting for around 90 percent of cases.^iv

About S-TRAC

The S-TRAC trial was a randomized double-blind Phase 3 trial of adjuvant
SUTENT vs. placebo in 615 patients with local, resected RCC at high risk
of recurrence. Patients received 50 mg/d of SUTENT or placebo in a four
weeks on, two weeks off schedule for one year until disease recurrence,
occurrence of secondary malignancy, significant toxicity or consent
withdrawal. The primary objective was to demonstrate an improvement in
DFS by blinded independent central radiologic review. DFS was defined as
the time interval from the date of randomization to the first date of
recurrence or the occurrence of a secondary malignancy or death.
Recurrence referred to relapse of the primary tumor locally or at
metastatic sites. The S-TRAC trial has two cohorts: Global and China.
These results are from the Global cohort only. Results from the China
cohort are not yet mature and will be reported at a later date.

About SUTENT^® (sunitinib malate)

SUTENT is an oral multi-kinase inhibitor that works by blocking multiple
molecular targets implicated in the growth, proliferation and spread of
cancer. Two important SUTENT targets, vascular endothelial growth factor
receptor (VEGFR) and platelet-derived growth factor receptor (PDGFR) are
expressed by many types of solid tumors and are thought to play a
crucial role in angiogenesis, the process by which tumors acquire blood
vessels, oxygen and nutrients needed for growth. SUTENT also inhibits
other targets important to tumor growth, including KIT, FLT3 and RET.

SUTENT is indicated for the treatment of advanced renal cell carcinoma
(RCC), gastrointestinal stromal tumor (GIST) after disease progression
on or intolerance to imatinib mesylate, and progressive,
well-differentiated pancreatic neuroendocrine tumors (pNET) in patients
with unresectable locally advanced or metastatic disease.

SUTENT Important Safety Information

Boxed Warning/Hepatotoxicity: Hepatotoxicity has been observed
in clinical trials and post-marketing experience. This
hepatotoxicity may be severe, and deaths have been reported. Monitor
liver function tests before initiation of treatment, during each cycle
of treatment, and as clinically indicated. SUTENT should be interrupted
for Grade 3 or 4 drug-related hepatic adverse events and discontinued if
there is no resolution. Do not restart SUTENT if patients subsequently
experience severe changes in liver function tests or have other signs
and symptoms of liver failure.

Pregnancy: Women of childbearing potential should be advised of
the potential hazard to the fetus and to avoid becoming pregnant.

Nursing mothers: Given the potential for serious adverse
reactions (ARs) in nursing infants, a decision should be made whether to
discontinue nursing or SUTENT.

Cardiovascular events: Cardiovascular events, including heart
failure, cardiomyopathy, myocardial ischemia, and myocardial infarction,
some of which were fatal, have been reported. Use SUTENT with caution in
patients who are at risk for, or who have a history of, these events.
Monitor patients for signs and symptoms of congestive heart failure
(CHF) and, in the presence of clinical manifestations, discontinuation
is recommended. Patients who presented with cardiac events, pulmonary
embolism, or cerebrovascular events within the previous 12 months were
excluded from clinical studies.

QT interval prolongation and Torsades de Pointes: SUTENT has been
shown to prolong QT interval in a dose-dependent manner, which may lead
to an increased risk for ventricular arrhythmias including Torsades de
Pointes, which has been seen in <0.1% of patients. Monitoring with
on-treatment electrocardiograms and electrolytes should be considered.

Hypertension: Hypertension may occur. Monitor blood pressure and
treat as needed with standard antihypertensive therapy. In cases of
severe hypertension, temporary suspension of SUTENT is recommended until
hypertension is controlled.

Reversible posterior leukoencephalopathy syndrome (RPLS): There
have been (<1%) reports, some fatal, of subjects presenting with
seizures and radiological evidence of RPLS.

Hemorrhagic events: Hemorrhagic events, including tumor-related
hemorrhage such as pulmonary hemorrhage, have occurred. Some of these
events were fatal. Perform serial complete blood counts (CBCs) and
physical examinations.

Tumor lysis syndrome (TLS): Cases of TLS have been reported
primarily in patients with high tumor burden. Monitor these patients
closely and treat as clinically indicated.

Thrombotic microangiopathy (TMA): TMA, including thrombotic
thrombocytopenic purpura and hemolytic uremic syndrome, sometimes
leading to renal failure or a fatal outcome, has been reported in
patients who received SUTENT as monotherapy and in combination with
bevacizumab. Discontinue SUTENT in patients developing TMA. Reversal of
the effects of TMA has been observed after treatment was discontinued.

Proteinuria: Proteinuria and nephrotic syndrome have been
reported. Some of these cases have resulted in renal failure and fatal
outcomes. Perform baseline and periodic urinalysis during treatment,
with follow-up measurement of 24-hour urine protein as clinically
indicated. Interrupt SUTENT and dose reduce if 24-hour urine protein is
≥3 g; discontinue SUTENT in cases of nephrotic syndrome or repeat
episodes of urine protein ≥3 g despite dose reductions.

Dermatologic toxicities: Severe cutaneous reactions have been
reported, including cases of erythema multiforme (EM), Stevens-Johnson
syndrome (SJS), and toxic epidermal necrolysis (TEN), some of which were
fatal. If signs or symptoms of EM, SJS, or TEN are present, SUTENT
treatment should be discontinued. If a diagnosis of SJS or TEN is
suspected, treatment must not be re-started. Necrotizing fasciitis,
including fatal cases, has been reported, including of the perineum and
secondary to fistula formation. Discontinue SUTENT in patients who
develop necrotizing fasciitis.

Thyroid dysfunction: Thyroid dysfunction may occur. Monitor
thyroid function in patients with signs and/or symptoms of thyroid
dysfunction, including hypothyroidism, hyperthyroidism, and thyroiditis,
and treat per standard medical practice.

Hypoglycemia: SUTENT has been associated with symptomatic
hypoglycemia, which may result in loss of consciousness or require
hospitalization. Reductions in blood glucose levels may be worse in
patients with diabetes. Check blood glucose levels regularly during and
after discontinuation of SUTENT. Assess whether anti-diabetic drug
dosage needs to be adjusted to minimize the risk of hypoglycemia.

Osteonecrosis of the jaw (ONJ): ONJ has been reported. Consider
preventive dentistry prior to treatment with SUTENT. If possible, avoid
invasive dental procedures, particularly in patients receiving
bisphosphonates.

Wound healing: Cases of impaired wound healing have been
reported. Temporary interruption of therapy with SUTENT is recommended
in patients undergoing major surgical procedures.

Adrenal function: Adrenal hemorrhage was observed in animal
studies. Monitor adrenal function in case of stress such as surgery,
trauma, or severe infection.

Laboratory tests: CBCs with platelet count and serum chemistries
including phosphate should be performed at the beginning of each
treatment cycle for patients receiving treatment with SUTENT.

CYP3A4 coadministration: Dose adjustments are recommended when
SUTENT is administered with CYP3A4 inhibitors or inducers. During
treatment with SUTENT, patients should not drink grapefruit juice, eat
grapefruit, or take St John’s Wort.

Most common ARs & most common grade 3/4 ARs (advanced RCC):
The most common ARs occurring in ≥20% of patients receiving SUTENT for
treatment-naïve metastatic RCC (all grades, vs IFNα) were diarrhea (66%
vs 21%), fatigue (62% vs 56%), nausea (58% vs 41%), anorexia (48% vs
42%), altered taste (47% vs 15%), mucositis/stomatitis (47% vs 5%), pain
in extremity/limb discomfort (40% vs 30%), vomiting (39% vs 17%),
bleeding, all sites (37% vs 10%), hypertension (34% vs 4%), dyspepsia
(34% vs 4%), arthralgia (30% vs 19%), abdominal pain (30% vs 12%), rash
(29% vs 11%), hand-foot syndrome (29% vs 1%), back pain (28% vs 14%),
cough (27% vs 14%), asthenia (26% vs 22%), dyspnea (26% vs 20%), skin
discoloration/yellow skin (25% vs 0%), peripheral edema (24% vs 5%),
headache (23% vs 19%), constipation (23% vs 14%), dry skin (23% vs 7%),
fever (22% vs 37%), and hair color changes (20% vs <1%). The most common
grade 3/4 ARs (occurring in ≥5% of patients with RCC receiving SUTENT vs
IFNα) were fatigue (15% vs 15%), hypertension (13% vs <1%), asthenia
(11% vs 6%), diarrhea (10% vs <1%), hand-foot syndrome (8% vs 0%),
dyspnea (6% vs 4%), nausea (6% vs 2%), back pain (5% vs 2%), pain in
extremity/limb discomfort (5% vs 2%), vomiting (5% vs 1%), and abdominal
pain (5% vs 1%).

Most common grade 3/4 lab abnormalities (advanced RCC): The most
common grade 3/4 lab abnormalities (occurring in ≥5% of patients with
RCC receiving SUTENT vs IFNα) included lymphocytes (18% vs 26%), lipase
(18% vs 8%), neutrophils (17% vs 9%), uric acid (14% vs 8%), platelets
(9% vs 1%), hemoglobin (8% vs 5%), sodium decreased (8% vs 4%),
leukocytes (8% vs 2%), glucose increased (6% vs 6%), phosphorus (6% vs
6%), and amylase (6% vs 3%).

Most common ARs & most common grade 3/4 ARs (imatinib-resistant or
-intolerant GIST): The most common ARs occurring in ≥20% of patients
with GIST and more commonly with SUTENT than placebo (all grades, vs
placebo) were diarrhea (40% vs 27%), anorexia (33% vs 29%), skin
discoloration (30% vs 23%), mucositis/stomatitis (29% vs 18%), asthenia
(22% vs 11%), altered taste (21% vs 12%), and constipation (20% vs 14%).
The most common grade 3/4 ARs (occurring in ≥4% of patients with GIST
receiving SUTENT vs placebo) were asthenia (5% vs 3%), hand-foot
syndrome (4% vs 3%), diarrhea (4% vs 0%), and hypertension (4% vs 0%).

Most common grade 3/4 lab abnormalities (imatinib-resistant or
-intolerant GIST): The most common grade 3/4 lab abnormalities
(occurring in ≥5% of patients with GIST receiving SUTENT vs placebo)
included lipase (10% vs 7%), neutrophils (10% vs 0%), amylase (5% vs
3%), and platelets (5% vs 0%).

Most common ARs & most common grade 3/4 ARs (advanced pNET):
The most common ARs occurring in ≥20% of patients with advanced pNET and
more commonly with SUTENT than placebo (all grades, vs placebo) were
diarrhea (59% vs 39%), stomatitis/oral syndromes (48% vs 18%), nausea
(45% vs 29%), abdominal pain (39% vs 34%), vomiting (34% vs 31%),
asthenia (34% vs 27%), fatigue (33% vs 27%), hair color changes (29% vs
1%), hypertension (27% vs 5%), hand-foot syndrome (23% vs 2%), bleeding
events (22% vs 10%), epistaxis (21% vs 5%), and dysgeusia (21% vs 5%).
The most commonly reported grade 3/4 ARs (occurring in ≥5% of patients
with advanced pNET receiving SUTENT vs placebo) were hypertension (10%
vs 1%), hand-foot syndrome (6% vs 0%), stomatitis/oral syndromes (6% vs
0%), abdominal pain (5% vs 10%), fatigue (5% vs 9%), asthenia (5% vs
4%), and diarrhea (5% vs 2%).

Most common grade 3/4 lab abnormalities (advanced pNET): The most
common grade 3/4 lab abnormalities (occurring in ≥5% of patients with
advanced pNET receiving SUTENT vs placebo) included decreased
neutrophils (16% vs 0%), increased glucose (12% vs 18%), increased
alkaline phosphatase (10% vs 11%), decreased phosphorus (7% vs 5%),
decreased lymphocytes (7% vs 4%), increased creatinine (5% vs 5%),
increased lipase (5% vs 4%), increased AST (5% vs 3%), and decreased
platelets (5% vs 0%).

Please see full
Prescribing Information, including BOXED WARNING and
Medication Guide, for SUTENT® (sunitinib malate).

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 is one of the most robust
in the industry, and 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. Because 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.

Pfizer Inc.: Working together for a healthier world^TM

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
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In addition, to learn more, follow us on Twitter at @Pfizer
and @Pfizer_News,
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and like us on Facebook at Facebook.com/Pfizer.

DISCLOSURE NOTICE: The information contained in this release is as of
October 10, 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 SUTENT and a
potential new indication for SUTENT for the treatment of RCC in the
adjuvant setting (the “potential indication”), 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, the uncertainties inherent in research and development,
including the ability to meet any anticipated 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 and when any supplemental new drug
applications may be filed in any jurisdictions for the potential
indication; 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 SUTENT; 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 Pfizer Data on File.
ⁱⁱ
Pfizer Data on File.
ⁱⁱⁱ Ferlay J, Shin HR, Bray F,
Forman D, Mathers C and Parkin DM.GLOBOCAN 2008 v1.2, Cancer Incidence
and Mortality Worldwide: IARC CancerBase No. 10 Lyon, France:
International Agency for Research on Cancer; 2010. Available at: http://globocan.iarc.fr.
Accessed September 2016.
^iv What is Kidney Cancer. James
Whale Fund for Kidney Cancer. Available at: http://www.jameswhalefund.org/kidneycancer/what-is-kidney-cancer/.
Accessed September 2016.

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