ROCKLAND, Mass. and
NEW YORK, Sept. 18, 2020 /PRNewswire/ -- EMD Serono, the
biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE) today
announced the publication of detailed results from the Phase III
JAVELIN Bladder 100 study online ahead of print in The New
England Journal of Medicine. These results were published
simultaneously with additional analyses being presented at the
European Society for Medical Oncology (ESMO) Virtual Congress 2020
and describe the efficacy of BAVENCIO® (avelumab)
as a first-line maintenance treatment across various subgroups of
patients with locally advanced or metastatic urothelial carcinoma
(UC) and highlight exploratory biomarkers as well as
patient-reported outcomes. In June, the US Food and Drug
Administration (FDA) approved BAVENCIO for the maintenance
treatment of patients with locally advanced or metastatic UC that
has not progressed with first-line platinum-containing chemotherapy
based on the JAVELIN Bladder 100 results.
In the JAVELIN Bladder 100 study, BAVENCIO plus best supportive
care (BSC) significantly extended overall survival (OS) compared
with BSC alone in the two primary populations of all randomized
patients and patients whose tumors were PD-L1+, and significantly
more patients who received BAVENCIO as first-line maintenance were
alive at one year.1 The clinical benefits of BAVENCIO
were seen across a range of patient populations.1,2
"These data, which supported the recent FDA approval and updates
to NCCN and ESMO guidelines, establish that BAVENCIO first-line
maintenance treatment could fundamentally change clinical practice
for the treatment of patients with locally advanced or metastatic
urothelial carcinoma," said Thomas
Powles, MBBS, MRCP, MD, Professor of Genitourinary Oncology,
Lead for Solid Tumour Research at Barts Cancer Institute, Queen
Mary University of London, and
Director of Barts Cancer Centre, London,
UK. "It is notable that the longer overall survival with
BAVENCIO maintenance therapy was observed across all pre-specified
subgroups examined and that this prolonged overall survival was
gained without a detrimental impact on patients' quality of
life."
Primary Analysis
In the JAVELIN Bladder 100 study, OS
was significantly longer with BAVENCIO plus BSC compared to BSC
alone in the primary population of all randomized patients (n=700)
whose disease had not progressed on first-line platinum-containing
chemotherapy:
- Median OS was 21.4 months (95% CI, 18.9 to 26.1) vs 14.3 months
(95% CI, 12.9 to 17.9), respectively (HR 0.69; 95% CI, 0.56 to
0.86; P<0.001).1
- At one year, 71.3% of patients (95% CI, 66.0% to 76.0%) in the
BAVENCIO arm were alive vs 58.4% (95% CI, 52.7% to 63.7%) of
patients who received BSC alone.1
In the other primary population of patients with PD-L1+ tumors
(n=358):
- OS was also significantly longer with BAVENCIO plus BSC vs BSC
alone (HR 0.56; 95% CI, 0.40 to 0.79; P<0.001).1
- At one year, 79.1% (95% CI, 72.1% to 84.5%) of patients who
received BAVENCIO were alive vs 60.4% (95% CI, 52.0% to 67.7%) in
the BSC arm.1
All endpoints were measured from the time of randomization,
after completion of four to six cycles of chemotherapy.
Subgroup Analysis
Results of an exploratory subgroup
analysis show that consistent results were observed with the
JAVELIN Bladder regimen of BAVENCIO first-line maintenance across
pre-specified subgroups, including best response to first-line
chemotherapy, type of chemotherapy regimen, site of baseline
metastasis, and other baseline factors.1 In particular,
hazard ratios for OS based on response to first-line chemotherapy
were as follows:
- 0.69 for complete or partial response
- 0.70 for stable disease
With regard to first-line chemotherapy regimen, hazard ratios
were as follows:
- 0.69 with gemcitabine plus cisplatin
- 0.66 with gemcitabine plus carboplatin
Further detail from the subgroup analysis were presented in an
on-demand mini oral session at the meeting (Presentation #704MO).
Additional data evaluating the association between clinical
outcomes and exploratory biomarkers will be presented in the
Proffered Paper 1 - GU, non prostate session on Saturday, September 19 (Presentation #699O), and
patient-reported outcomes are featured in an on-demand e-poster
display (Presentation #745P).
Safety
No new safety signals were identified in the
JAVELIN Bladder 100 study, and the safety profile was consistent
with previous studies of BAVENCIO monotherapy.1
Treatment-related adverse events of grade 3 or higher occurred in
57 patients (16.6%) treated with BAVENCIO plus BSC; no grade 3 or
higher treatment-related events occurred in the control
arm.1 No grade 4 or fatal immune-related adverse events
occurred.1 Investigators attributed two patient deaths
in the BAVENCIO plus BSC arm (0.6%), due to sepsis and ischemic
stroke, to study treatment toxicity.1
About JAVELIN Bladder 100
JAVELIN Bladder 100 (NCT02603432) is a Phase III, multicenter,
multinational, randomized, open-label, parallel-arm study
investigating first-line maintenance treatment with BAVENCIO plus
BSC versus BSC alone in patients with locally advanced or
metastatic UC. The primary endpoint was OS in the two primary
populations of all patients and patients with PD-L1+ tumors defined
by the Ventana SP263 assay. Secondary endpoints included
progression-free survival, anti-tumor activity, safety,
pharmacokinetics, immunogenicity, predictive biomarkers and
patient-reported outcomes in the co-primary populations. All
primary and secondary endpoints are measured from the time of
randomization.
About Urothelial Carcinoma
Bladder cancer is the
tenth most common cancer worldwide.4 In 2018, there were
over half a million new cases of bladder cancer diagnosed, with
around 200,000 deaths from the disease globally.4 In the
US, an estimated 80,470 cases of bladder cancer were diagnosed in
2019, with around 12,500 locally advanced or metastatic cases
presented annually.5,6 UC, which accounts for about 90%
of all bladder cancers,7 becomes harder to treat as it
advances, spreading through the layers of the bladder
wall.8 Only 25% to 55% of patients receive any
second-line therapy after first-line chemotherapy.9-15
In the US and EU5 markets, approximately 40% to 50% of patients
receive an immune checkpoint inhibitor in second-line
therapy.3 For patients with advanced UC, the five-year
survival rate is 5%.5
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.16-18 In
November 2014, Merck KGaA, Darmstadt,
Germany and Pfizer announced a
strategic alliance to co-develop and co-commercialize
BAVENCIO.
BAVENCIO Approved Indications
BAVENCIO®
(avelumab) is indicated in the US for the maintenance treatment of
patients with locally advanced or metastatic urothelial carcinoma
(UC) that has not progressed with first-line platinum-containing
chemotherapy. BAVENCIO is also indicated for the treatment of
patients with locally advanced or metastatic UC who have disease
progression during or following platinum-containing chemotherapy,
or have disease progression within 12 months of neoadjuvant or
adjuvant treatment with platinum-containing chemotherapy.
BAVENCIO in combination with axitinib is indicated in the US for
the first-line treatment of patients with advanced renal cell
carcinoma (RCC).
In the US, the FDA granted accelerated approval for BAVENCIO for
the treatment of adults and pediatric patients 12 years and older
with metastatic Merkel cell carcinoma (MCC). This indication is
approved under accelerated approval based on tumor response rate
and duration of response. Continued approval may be contingent upon
verification and description of clinical benefit in confirmatory
trials.
BAVENCIO is currently approved for patients with MCC in 50
countries globally, with the majority of these approvals in a broad
indication that is not limited to a specific line of treatment.
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
fatal, 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 fatal, and
11 (0.6%) with Grade 3.
BAVENCIO in combination with axitinib 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 axitinib 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 axitinib, 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 control 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 axitinib: 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.
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 axitinib 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 axitinib for Grade 3-4 cardiovascular
events. MACE occurred in 7% of patients with advanced RCC
treated with BAVENCIO in combination with axitinib 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.
The most common adverse reactions (all grades, ≥20%) in patients
with metastatic Merkel cell carcinoma (MCC) were fatigue (50%),
musculoskeletal pain (32%), diarrhea (23%), nausea (22%),
infusion-related reaction (22%), rash (22%), decreased appetite
(20%), and peripheral edema (20%).
Selected treatment-emergent laboratory abnormalities (all
grades, ≥20%) in patients with metastatic MCC were lymphopenia
(49%), anemia (35%), increased aspartate aminotransferase (34%),
thrombocytopenia (27%), and increased alanine aminotransferase
(20%).
A fatal adverse reaction (sepsis) occurred in one (0.3%) patient
with locally advanced or metastatic urothelial carcinoma (UC)
receiving BAVENCIO plus best supportive care (BSC) as first-line
maintenance treatment. In patients with previously treated locally
advanced or metastatic UC, fourteen patients (6%) who were treated
with BAVENCIO experienced either pneumonitis, respiratory failure,
sepsis/urosepsis, cerebrovascular accident, or gastrointestinal
adverse events, which led to death.
The most common adverse reactions (all grades, ≥20%) in patients
with locally advanced or metastatic UC receiving BAVENCIO plus BSC
(vs BSC alone) as first-line maintenance treatment were fatigue
(35% vs 13%), musculoskeletal pain (24% vs 15%), urinary tract
infection (20% vs 11%), and rash (20% vs 2.3%). In patients
with previously treated locally advanced or metastatic UC receiving
BAVENCIO, the most common adverse reactions (all grades, ≥20%) were
fatigue, infusion-related reaction, musculoskeletal pain, nausea,
decreased appetite, and urinary tract infection.
Selected laboratory abnormalities (all grades, ≥20%) in patients
with locally advanced or metastatic UC receiving BAVENCIO plus BSC
(vs BSC alone) as first-line maintenance treatment were blood
triglycerides increased (34% vs 28%), alkaline phosphate increased
(30% vs 20%), blood sodium decreased (28% vs 20%), lipase increased
(25% vs 16%), aspartate aminotransferase (AST) increased (24% vs
12%), blood potassium increased (24% vs 16%), alanine
aminotransferase (ALT) increased (24% vs 12%), blood cholesterol
increased (22% vs 16%), serum amylase increased (21% vs 12%),
hemoglobin decreased (28% vs 18%), and white blood cell decreased
(20% vs 10%).
Fatal adverse reactions occurred in 1.8% of patients with
advanced renal cell carcinoma (RCC) receiving BAVENCIO in
combination with axitinib. 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 axitinib
(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 axitinib (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%).
Please see full US Prescribing Information and Medication
Guide available at http://www.BAVENCIO.com.
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.
All Merck KGaA, Darmstadt, Germany, press releases are distributed by
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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 1,500 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 57,000 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 2019, Merck KGaA, Darmstadt,
Germany, generated sales of € 16.2
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.: 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.
Pfizer Disclosure Notice
The information contained in
this release is as of September 18,
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 BAVENCIO
(avelumab), including an indication for first-line maintenance
therapy for BAVENCIO for the treatment of patients with locally
advanced or metastatic urothelial 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;
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; 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 in any other
jurisdictions for BAVENCIO for first-line maintenance therapy for
locally advanced or metastatic urothelial carcinoma in any
jurisdictions or for any other potential indications for BAVENCIO
or combination therapies in any jurisdictions; whether and when
regulatory authorities in any jurisdictions where any applications
are pending or may be submitted for BAVENCIO or combination
therapies, including BAVENCIO for locally advanced or metastatic
urothelial carcinoma 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, including BAVENCIO for locally
advanced or metastatic urothelial carcinoma; the impact of COVID-19
on our 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, 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.
References
- Powles T, Park SH, Voog E, et al. Avelumab maintenance therapy
for advanced or metastatic urothelial cancer. N Engl J Med.
2020. [Epub ahead of print]. DOI: 10.1056/NEJMoa2002788.
- Grivas P, Park SE, Voog E, et al. Avelumab 1L maintenance +
best supportive care (BSC) vs BSC alone with 1L chemotherapy for
advanced urothelial carcinoma: subgroup analyses from JAVELIN
Bladder 100. Presented at ESMO 2020.
- Kantar Health. CANCERMPACT – treatment
architecture. https://www.kantarhealth.com/docs/datasheets/cancermpact-treatment-architecture.pdf?sfvrsn=6&sfvrsn=6.
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185 countries. CA: A Cancer Journal. 2018;68(6):394-424.
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https://seer.cancer.gov/statfacts/html/urinb.html. Accessed
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metastatic urothelial carcinoma: a survey of clinical practice
perspectives among US oncologists. Bladder Cancer.
2019;5:281-288.
- Cancer.net. Bladder cancer: introduction.
https://www.cancer.net/cancer-types/bladder-cancer/introduction.
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https://www.cancer.org/cancer/bladder-cancer/about/what-is-bladder-cancer.html.
Accessed September 2020.
- Cheeseman S, et al. Current treatment and outcomes benchmark
for locally advanced or metastatic urothelial cancer from a large
UK-based single centre. Front Oncol. 2020;10:167.
- Aly A, et al. Overall survival, costs, and healthcare resource
use by line of therapy in Medicare patients with newly diagnosed
metastatic urothelial carcinoma. J Med Econ.
2019;22:662-670.
- Galsky MD, et al. Real-world effectiveness of chemotherapy in
elderly patients with metastatic bladder cancer in the United States. Bladder Cancer.
2018;4(2):227-238.
- Fisher MD, et al. Treatment patterns and outcomes in stage IV
bladder cancer in a community oncology setting: 2008-2015. Clin
Genitourin Cancer. 2018;16:e1171-e1179.
- Niegisch G, et al. A real-world data study to evaluate
treatment patterns, clinical characteristics and survival outcomes
for first- and second-line treatment in locally advanced and
metastatic urothelial cancer patients in Germany. J Cancer.
2018;9(8):1337-1348.
- Flannery K, et al. Outcomes in patients with metastatic bladder
cancer in the USA: a retrospective
electronic medical record study. Future Oncol.
2019;15:1323-1334.
- Simeone JC, et al. Treatment patterns and overall survival in
metastatic urothelial carcinoma in a real-world, US setting.
Cancer Epidemiol. 2019;60:121-127.
- Dolan DE, Gupta S. PD-1 pathway inhibitors: changing the
landscape of cancer immunotherapy. Cancer Control.
2014;21(3):231-237.
- Dahan R, Sega E, Engelhardt J, et al. FcγRs modulate the
anti-tumor activity of antibodies targeting the PD-1/PD-L1 axis.
Cancer Cell. 2015;28(3):285-295.
- Boyerinas B, Jochems C, Fantini M, et al. Antibody-dependent
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