ROCKLAND, Mass. and
NEW YORK, May 14, 2019 /PRNewswire/ --
- BAVENCIO is the first anti-PD-L1 in combination with INLYTA
approved by FDA for first-line treatment of patients with advanced
renal cell carcinoma (RCC)
- Phase III study showed combination significantly lowered
risk of disease progression or death by 31% and extended
progression-free survival by 5.4 months for patients with advanced
RCC compared with sunitinib
- Combination approved based on Phase III data in an
overall population that included patients regardless of PD-L1
expression and across favorable, intermediate and poor prognostic
groups
- Additional regulatory reviews for BAVENCIO plus
INLYTA in advanced RCC are underway worldwide, including in the
European Union and Japan
EMD Serono, the biopharmaceutical business of Merck KGaA,
Darmstadt, Germany in the US and
Canada, and Pfizer Inc. (NYSE:
PFE) today announced that the US Food and Drug Administration (FDA)
has approved BAVENCIO® (avelumab) in combination with
INLYTA® (axitinib) for the first-line treatment of
patients with advanced renal cell carcinoma (RCC). This is the
first FDA approval for an anti-PD-L1 therapy as part of a
combination regimen for patients with advanced RCC. The approval of
BAVENCIO in combination with INLYTA was based on positive results
from the Phase III JAVELIN Renal 101 study (NCT02684006), in which
the combination significantly improved median progression-free
survival (PFS) compared with sunitinib by more than five months in
the intent-to-treat (ITT) patient population (HR: 0.69 [95% CI:
0.56–0.84]; 2-sided p-value=0.0002; median PFS for BAVENCIO in
combination with INLYTA: 13.8 months [95% CI: 11.1-NE]; sunitinib:
8.4 months [95% CI: 6.9-11.1]). The ITT population included
patients regardless of PD-L1 expression and across IMDC
(International Metastatic Renal Cell Carcinoma Database) prognostic
risk groups (favorable 21%, intermediate 62% and poor
16%).1
"As we look to continue to improve outcomes for people with
advanced RCC, new treatment approaches have the potential to
benefit patients," said Robert J.
Motzer, M.D., Jack and Dorothy Byrne Chair in Clinical
Oncology, Memorial Sloan Kettering Cancer Center, New York, US, and principal investigator for
JAVELIN Renal 101. "With today's FDA approval of avelumab in
combination with axitinib, we can now offer patients with advanced
RCC a first-line treatment option that combines a PD-L1
immunotherapy with a well-known VEGFR TKI to provide a significant
reduction in the risk of disease progression or death and doubling
of the response rate compared with sunitinib."
RCC is a type of cancer where PD-L1 expression may contribute to
inhibition of the immune response against the tumor.2 It
is also a highly vascular tumor, in which vascular endothelial
growth factor (VEGF) plays a key role.3
"A kidney cancer diagnosis is life-changing for both patients
and their loved ones, and having a treatment strategy for their
disease quickly becomes a priority," said Dena Battle, President, KCCure. "The approval of
new treatments such as BAVENCIO in combination with INLYTA gives
patients with advanced RCC much-needed options."
There is a significant unmet need for first-line treatments that
delay progression and have an acceptable safety profile.
Approximately 20% to 30% of patients are first diagnosed with RCC
at the advanced stage, and 30% of patients treated for an earlier
stage go on to develop metastases.4,5 About half of
patients living with advanced RCC do not go on to receive
additional treatment after first-line
therapy,6,7 for reasons that may include poor
performance status or adverse events from their initial
treatment.6,8,9
"Today's approval of BAVENCIO in combination with INLYTA builds
on Pfizer's long heritage in bringing innovation to the RCC
community with the hopes of making a significant and meaningful
impact on the lives of patients," said Andy
Schmeltz, Global President, Pfizer Oncology. "For more than
12 years, Pfizer has led the field in its commitment to developing
new treatments for patients with advanced kidney cancer."
"With today's FDA approval of BAVENCIO in combination with
INLYTA, we feel privileged that we can offer patients with
first-line advanced renal cell carcinoma a new treatment option,"
said Rehan Verjee, President, EMD
Serono, and Global Head of Innovative Medicine Franchises,
Merck KGaA, Darmstadt, Germany.
In JAVELIN Renal 101, the objective response rate (ORR) was
doubled in the ITT population with BAVENCIO in combination with
INLYTA versus sunitinib (51.4% [95% CI: 46.6-56.1] vs. 25.7% [95%
CI: 21.7-30.0]). With a median overall survival (OS) follow-up of
19 months, data for the trial's other primary endpoint of OS were
immature, with 27% of deaths in the ITT population, and the trial
is continuing as planned. The most common adverse reactions (≥20%)
were diarrhea, fatigue, hypertension, musculoskeletal pain, nausea,
mucositis, palmar-plantar erythrodysesthesia, dysphonia, decreased
appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnea,
abdominal pain and headache. Serious adverse reactions occurred in
35% of patients receiving BAVENCIO in combination with
INLYTA. The incidence of major adverse cardiovascular events
(MACE) was higher with BAVENCIO in combination with INLYTA versus
sunitinib.1 Findings from the study have been published
in The New England Journal of Medicine.10
The European Medicines Agency (EMA) validated the Type II
variation application for BAVENCIO in combination with INLYTA in
advanced RCC in March 2019, and a
supplemental application for BAVENCIO in combination with INLYTA in
unresectable or metastatic RCC was submitted in Japan in
January 2019.
The alliance is committed to providing patient access and
reimbursement support through its CoverOne® program to
patients who have been prescribed BAVENCIO. This program provides a
spectrum of patient access and reimbursement support services
intended to help US patients prescribed BAVENCIO receive
appropriate access. CoverOne may be reached by phone at 844-8COVER1
(844-826-8371) or online at www.CoverOne.com.
Pfizer is committed to ensuring that patients who are prescribed
INLYTA have access to this innovative therapy. Patients in the US
have access to Pfizer Oncology Together™, which offers personalized
support and financial assistance resources to help patients access
their prescribed Pfizer Oncology medications. For more information,
please call 1-877-744-5675 or
visit PfizerOncologyTogether.com.
In an effort to streamline the patient enrollment process,
EMD Serono and Pfizer have partnered to create a single
enrollment form for the BAVENCIO and INLYTA combination for
patients with advanced RCC that can be processed through both
CoverOne and Pfizer Oncology Together. Each program will
independently conduct the access and reimbursement activities for
the product for which it is responsible.
About Renal Cell Carcinoma
In 2019, an estimated
73,820 new cases of kidney cancer will be diagnosed in the US, and
approximately 14,770 people will die from the disease.11
RCC is the most common form of kidney cancer, accounting for about
2% to 3% of all cancers in adults.12,13 Approximately
20% to 30% of patients with kidney cancer are first diagnosed at
the advanced stage.4 The five-year survival rate
for patients with metastatic RCC is approximately
12%.14
About the JAVELIN Renal 101 study
The Phase III
JAVELIN Renal 101 study is a randomized (1:1), multicenter,
open-label study of BAVENCIO in combination with INLYTA in 886
patients with untreated advanced RCC regardless of tumor PD-L1
expression [intent-to-treat (ITT) population]. Patients with
autoimmune disease or conditions requiring systemic
immunosuppression were excluded. The major efficacy outcome
measures were PFS as assessed by a Blinded Independent Central
Review (BICR) using RECIST v1.1 and OS in patients with
PD-L1-positive tumors using a clinical trial assay (PD-L1
expression level ≥1%). If PFS was statistically significant in
patients with PD-L1-positive tumors, it was then tested in the ITT
population. The hazard ratio for PFS in patients with
PD-L1-positive tumors was HR 0.61 (95% CI: 0.48, 0.79). PFS and OS
in the ITT population, overall response and safety are included as
secondary endpoints. The study is continuing for OS.
About the JAVELIN Clinical Development Program
The
clinical development program for avelumab, known as JAVELIN,
involves at least 30 clinical programs and about 10,000
patients evaluated across more than 15 different tumor types. In
addition to RCC, these tumor types include
gastric/gastro-esophageal junction cancer, head and neck cancer,
Merkel cell carcinoma, non-small cell lung cancer, and urothelial
carcinoma.
About BAVENCIO® (avelumab)
BAVENCIO is a
human anti-programmed death ligand-1 (PD-L1) antibody. BAVENCIO has
been shown in preclinical models to engage both the adaptive and
innate immune functions. By blocking the interaction of PD-L1 with
PD-1 receptors, BAVENCIO has been shown to release the suppression
of the T cell-mediated antitumor immune response in preclinical
models.15-17 BAVENCIO has also been shown to induce NK
cell-mediated direct tumor cell lysis via antibody-dependent
cell-mediated cytotoxicity (ADCC) in vitro.17-19 In
November 2014, EMD Serono and Pfizer
announced a strategic alliance to co-develop and co-commercialize
BAVENCIO.
BAVENCIO Approved Indication in the
US
BAVENCIO® (avelumab) in combination with
INLYTA® (axitinib) is indicated in the US for the
first-line treatment of patients with advanced renal cell carcinoma
(RCC).
BAVENCIO Important Safety Information from the US
FDA-Approved Label
BAVENCIO can
cause immune-mediated pneumonitis, including fatal
cases. Monitor patients for signs and symptoms of pneumonitis, and
evaluate suspected cases with radiographic imaging. Administer
corticosteroids for Grade 2 or greater pneumonitis. Withhold
BAVENCIO for moderate (Grade 2) and permanently discontinue for
severe (Grade 3), life-threatening (Grade 4), or recurrent moderate
(Grade 2) pneumonitis. Pneumonitis occurred in 1.2% of patients,
including one (0.1%) patient with Grade 5, one (0.1%) with Grade 4,
and five (0.3%) with Grade 3.
BAVENCIO can cause hepatotoxicity and immune-mediated
hepatitis, including fatal cases. Monitor patients for abnormal
liver tests prior to and periodically during treatment. Administer
corticosteroids for Grade 2 or greater hepatitis. Withhold BAVENCIO
for moderate (Grade 2) immune-mediated hepatitis until resolution
and permanently discontinue for severe (Grade 3) or
life-threatening (Grade 4) immune-mediated hepatitis.
Immune-mediated hepatitis occurred with BAVENCIO as a single agent
in 0.9% of patients, including two (0.1%) patients with Grade 5,
and 11 (0.6%) with Grade 3.
BAVENCIO in combination
with INLYTA can cause hepatotoxicity with higher than
expected frequencies of Grade 3 and 4 alanine aminotransferase
(ALT) and aspartate aminotransferase (AST) elevation. Consider more
frequent monitoring of liver enzymes as compared to when the drugs
are used as monotherapy. Withhold BAVENCIO and INLYTA for moderate
(Grade 2) hepatotoxicity and permanently discontinue the
combination for severe or life-threatening (Grade 3 or 4)
hepatotoxicity. Administer corticosteroids as needed. In patients
treated with BAVENCIO in combination with INLYTA, Grades 3 and 4
increased ALT and AST occurred in 9% and 7% of patients,
respectively, and immune-mediated hepatitis occurred in 7% of
patients, including 4.9% with Grade 3 or 4.
BAVENCIO can cause immune-mediated colitis. Monitor
patients for signs and symptoms of colitis. Administer
corticosteroids for Grade 2 or greater colitis. Withhold BAVENCIO
until resolution for moderate or severe (Grade 2 or 3) colitis
until resolution. Permanently discontinue for life-threatening
(Grade 4) or recurrent (Grade 3) colitis upon reinitiation of
BAVENCIO. Immune-mediated colitis occurred in 1.5% of patients,
including seven (0.4%) with Grade 3.
BAVENCIO can cause immune-mediated endocrinopathies,
including adrenal insufficiency, thyroid disorders, and type 1
diabetes mellitus.
Monitor patients for signs and
symptoms of adrenal insufficiency during and after
treatment, and administer corticosteroids as appropriate. Withhold
BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) adrenal
insufficiency. Adrenal insufficiency was reported in 0.5% of
patients, including one (0.1%) with Grade 3.
Thyroid disorders can occur
at any time during treatment. Monitor patients for changes in
thyroid function at the start of treatment, periodically during
treatment, and as indicated based on clinical evaluation. Manage
hypothyroidism with hormone replacement therapy and hyperthyroidism
with medical management. Withhold BAVENCIO for severe (Grade 3) or
life-threatening (Grade 4) thyroid disorders. Thyroid disorders,
including hypothyroidism, hyperthyroidism, and thyroiditis, were
reported in 6% of patients, including three (0.2%) with Grade
3.
Type 1 diabetes mellitus
including diabetic ketoacidosis: Monitor patients for hyperglycemia
or other signs and symptoms of diabetes. Withhold BAVENCIO and
administer antihyperglycemics or insulin in patients with severe or
life-threatening (Grade ≥3) hyperglycemia, and resume treatment
when metabolic control is achieved. Type 1 diabetes mellitus
without an alternative etiology occurred in 0.1% of patients,
including two cases of Grade 3 hyperglycemia.
BAVENCIO can cause immune-mediated nephritis and renal
dysfunction. Monitor patients for elevated serum creatinine
prior to and periodically during treatment. Administer
corticosteroids for Grade 2 or greater nephritis. Withhold BAVENCIO
for moderate (Grade 2) or severe (Grade 3) nephritis until
resolution to Grade 1 or lower. Permanently discontinue BAVENCIO
for life-threatening (Grade 4) nephritis. Immune-mediated nephritis
occurred in 0.1% of patients.
BAVENCIO can result in other severe and fatal immune-mediated
adverse reactions involving any organ system during treatment
or after treatment discontinuation. For suspected immune-mediated
adverse reactions, evaluate to confirm or rule out an
immune-mediated adverse reaction and to exclude other causes.
Depending on the severity of the adverse reaction, withhold or
permanently discontinue BAVENCIO, administer high-dose
corticosteroids, and initiate hormone replacement therapy, if
appropriate. Resume BAVENCIO when the immune-mediated adverse
reaction remains at Grade 1 or lower following a corticosteroid
taper. Permanently discontinue BAVENCIO for any severe (Grade 3)
immune-mediated adverse reaction that recurs and for any
life-threatening (Grade 4) immune-mediated adverse reaction. The
following clinically significant immune-mediated adverse reactions
occurred in less than 1% of 1738 patients treated with BAVENCIO as
a single agent or in 489 patients who received BAVENCIO in
combination with INLYTA: myocarditis including fatal cases,
pancreatitis including fatal cases, myositis, psoriasis, arthritis,
exfoliative dermatitis, erythema multiforme, pemphigoid,
hypopituitarism, uveitis, Guillain-Barré syndrome, and systemic
inflammatory response.
BAVENCIO can cause severe or life-threatening
infusion-related reactions. Premedicate patients with an
antihistamine and acetaminophen prior to the first 4 infusions and
for subsequent infusions based upon clinical judgment and
presence/severity of prior infusion reactions. Monitor patients for
signs and symptoms of infusion-related reactions, including
pyrexia, chills, flushing, hypotension, dyspnea, wheezing, back
pain, abdominal pain, and urticaria. Interrupt or slow the rate of
infusion for mild (Grade 1) or moderate (Grade 2) infusion-related
reactions. Permanently discontinue BAVENCIO for severe (Grade 3) or
life-threatening (Grade 4) infusion-related reactions.
Infusion-related reactions occurred in 25% of patients, including
three (0.2%) patients with Grade 4 and nine (0.5%) with Grade
3.
BAVENCIO in combination with INLYTA can cause major
adverse cardiovascular events (MACE) including severe and fatal
events. Consider baseline and periodic evaluations of left
ventricular ejection fraction. Monitor for signs and symptoms of
cardiovascular events. Optimize management of cardiovascular risk
factors, such as hypertension, diabetes, or dyslipidemia.
Discontinue BAVENCIO and INLYTA for Grade 3-4 cardiovascular
events. MACE occurred in 7% of patients with advanced RCC treated
with BAVENCIO in combination with INLYTA compared to 3.4% treated
with sunitinib. These events included death due to cardiac events
(1.4%), Grade 3-4 myocardial infarction (2.8%), and Grade 3-4
congestive heart failure (1.8%).
BAVENCIO can cause fetal harm when administered to a
pregnant woman. Advise patients of the potential risk to a fetus
including the risk of fetal death. Advise females of childbearing
potential to use effective contraception during treatment with
BAVENCIO and for at least 1 month after the last dose of BAVENCIO.
It is not known whether BAVENCIO is excreted in human milk. Advise
a lactating woman not to breastfeed during treatment and for
at least 1 month after the last dose of BAVENCIO due to the
potential for serious adverse reactions in breastfed infants.
Please see full US Prescribing Information and Medication Guide
available at http://www.BAVENCIO.com.
INLYTA Important Safety Information from the US FDA-Approved
Label
Hypertension including hypertensive
crisis has been observed with INLYTA. Blood pressure should be
well controlled prior to initiating INLYTA. Monitor for
hypertension and treat as needed. For persistent hypertension,
despite use of antihypertensive medications, reduce the dose.
Discontinue INLYTA if hypertension is severe and persistent despite
use of antihypertensive therapy and dose reduction of INLYTA, and
discontinuation should be considered if there is evidence of
hypertensive crisis.
Arterial and venous thrombotic events have been observed
with INLYTA and can be fatal. Use with caution in patients who are
at increased risk or who have a history of these events.
Hemorrhagic events, including fatal events, have been
reported with INLYTA. INLYTA has not been studied in patients with
evidence of untreated brain metastasis or recent active
gastrointestinal bleeding and should not be used in those patients.
If any bleeding requires medical intervention, temporarily
interrupt the INLYTA dose.
Cardiac failure has been observed with INLYTA and can be
fatal. Monitor for signs or symptoms of cardiac failure throughout
treatment with INLYTA. Management of cardiac failure may require
permanent discontinuation of INLYTA.
Gastrointestinal perforation and fistula, including
death, have occurred with INLYTA. Use with caution in patients at
risk for gastrointestinal perforation or fistula. Monitor for
symptoms of gastrointestinal perforation or fistula periodically
throughout treatment.
Hypothyroidism requiring thyroid hormone replacement has
been reported with INLYTA. Monitor thyroid function before
initiation of, and periodically throughout, treatment.
No formal studies of the effect of INLYTA on wound
healing have been conducted. Stop INLYTA at least 24 hours
prior to scheduled surgery.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS)
has been observed with INLYTA. If signs or symptoms occur,
permanently discontinue treatment.
Proteinuria has been observed with INLYTA. Monitor for
proteinuria before initiation of, and periodically throughout,
treatment with INLYTA. For moderate to severe proteinuria, reduce
the dose or temporarily interrupt treatment.
Liver enzyme elevation has been observed during treatment
with INLYTA. Monitor ALT, AST, and bilirubin before initiation of,
and periodically throughout, treatment.
For patients with moderate hepatic impairment, the
starting dose should be decreased. INLYTA has not been studied in
patients with severe hepatic impairment.
INLYTA can cause fetal harm. Advise patients of the
potential risk to the fetus and to use effective contraception
during treatment.
Avoid strong CYP3A4/5 inhibitors. If unavoidable, reduce
the dose. Grapefruit or grapefruit juice may also increase INLYTA
plasma concentrations and should be avoided.
Avoid strong CYP3A4/5 inducers and, if possible, avoid
moderate CYP3A4/5 inducers.
For more information and full Prescribing Information,
visit www.INLYTA.com.
ADVERSE REACTIONS (BAVENCIO + INLYTA)
Fatal adverse
reactions occurred in 1.8% of patients with advanced renal
cell carcinoma (RCC) receiving BAVENCIO in combination with
INLYTA. These included sudden cardiac death (1.2%), stroke (0.2%),
myocarditis (0.2%), and necrotizing pancreatitis (0.2%).
The most common adverse reactions (all grades, ≥20%) in
patients with advanced RCC receiving BAVENCIO in combination
with INLYTA (vs sunitinib) were diarrhea (62% vs 48%), fatigue (53%
vs 54%), hypertension (50% vs 36%), musculoskeletal pain (40% vs
33%), nausea (34% vs 39%), mucositis (34% vs 35%), palmar-plantar
erythrodysesthesia (33% vs 34%), dysphonia (31% vs 3.2%), decreased
appetite (26% vs 29%), hypothyroidism (25% vs 14%), rash (25% vs
16%), hepatotoxicity (24% vs 18%), cough (23% vs 19%), dyspnea (23%
vs 16%), abdominal pain (22% vs 19%), and headache (21% vs
16%).
Selected laboratory abnormalities (all grades, ≥20%)
worsening from baseline in patients with advanced RCC
receiving BAVENCIO in combination with INLYTA (vs sunitinib) were
blood triglycerides increased (71% vs 48%), blood creatinine
increased (62% vs 68%), blood cholesterol increased (57% vs 22%),
alanine aminotransferase increased (ALT) (50% vs 46%), aspartate
aminotransferase increased (AST) (47% vs 57%), blood sodium
decreased (38% vs 37%), lipase increased (37% vs 25%), blood
potassium increased (35% vs 28%), platelet count decreased (27% vs
80%), blood bilirubin increased (21% vs 23%), and hemoglobin
decreased (21% vs 65%).
About Merck KGaA, Darmstadt, Germany-Pfizer
Alliance
Immuno-oncology is a top priority for Merck KGaA,
Darmstadt, Germany and Pfizer. The global strategic alliance
between Merck KGaA, Darmstadt, Germany and Pfizer enables the
companies to benefit from each other's strengths and capabilities
and further explore the therapeutic potential of BAVENCIO, an
anti-PD-L1 antibody initially discovered and developed by Merck
KGaA, Darmstadt, Germany. The
immuno-oncology alliance is jointly developing and commercializing
BAVENCIO. The alliance is focused on developing high-priority
international clinical programs to investigate BAVENCIO as a
monotherapy as well as combination regimens, and is striving to
find new ways to treat cancer.
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About EMD Serono, Inc.
EMD Serono - the
biopharmaceutical business of Merck KGaA, Darmstadt, Germany,
in the U.S. and Canada - is engaged in the discovery,
research and development of medicines for patients with difficult
to treat diseases. The business is committed to transforming lives
by developing and delivering meaningful solutions that help address
the therapeutic and support needs of individual patients. Building
on a proven legacy and deep expertise in neurology, fertility and
endocrinology, EMD Serono is developing potential new oncology and
immuno-oncology medicines while continuing to explore potential
therapeutic options for diseases such as psoriasis, lupus and MS.
Today, the business has approximately 1,300 employees around the
country with commercial, clinical and research operations based in
the company's home state
of Massachusetts. www.emdserono.com.
About Merck KGaA, Darmstadt, Germany
Merck KGaA, Darmstadt,
Germany, a leading science and
technology company, operates across healthcare, life science and
performance materials. Around 52,000 employees work to make a
positive difference to millions of people's lives every day by
creating more joyful and sustainable ways to live. From advancing
gene editing technologies and discovering unique ways to treat the
most challenging diseases to enabling the intelligence of devices –
the company is everywhere. In 2018, Merck KGaA, Darmstadt,
Germany, generated sales of € 14.8
billion in 66 countries.
The company holds the global rights to the name and trademark
"Merck" internationally. The only exceptions are the United States and Canada, where the business sectors of Merck
KGaA, Darmstadt, Germany operate
as EMD Serono in healthcare, MilliporeSigma in life science, and
EMD Performance Materials. Since its founding 1668, scientific
exploration and responsible entrepreneurship have been key to the
company's technological and scientific advances. To this day, the
founding family remains the majority owner of the publicly listed
company.
Pfizer Inc.: Working together for a healthier
world®
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. Our global portfolio includes
medicines and vaccines as well as many of the world's best-known
consumer health care 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
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Pfizer Disclosure Notice
The information contained in
this release is as of May 14, 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 BAVENCIO
(avelumab), including a new indication approved in the U.S. for
BAVENCIO in combination with INLYTA (axitinib) for the treatment of
patients with advanced renal cell carcinoma, the alliance between
Merck KGaA, Darmstadt, Germany, and Pfizer involving BAVENCIO 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 BAVENCIO
and INLYTA; 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 and
uncertainties regarding whether the other primary endpoint of
JAVELIN Renal 101 will be met; risks associated with interim 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 any drug
applications may be filed for BAVENCIO in combination with INLYTA
in any other jurisdictions or in any jurisdictions for any other
potential indications for BAVENCIO or combination therapies;
whether and when the pending applications in the European Union and
Japan for BAVENCIO in combination
with INLYTA may be approved and whether and when regulatory
authorities in any jurisdictions where any other applications are
pending or may be submitted for BAVENCIO or combination therapies,
including BAVENCIO in combination with INLYTA may approve any such
applications, 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 they 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 BAVENCIO or combination
therapies, including BAVENCIO in combination with INLYTA; 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.
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