ROCKLAND, Mass. and
NEW YORK, March 23, 2017
/PRNewswire/ -- 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)
Injection 20 mg/mL, for intravenous use, for the treatment of
adults and pediatric patients 12 years and older with metastatic
Merkel cell carcinoma (mMCC). This indication is approved under
accelerated approval based on tumor response and duration of
response. Continued approval for this indication may be contingent
upon verification and description of clinical benefit in
confirmatory trials.1 BAVENCIO was developed, reviewed
and approved through the FDA's Breakthrough Therapy Designation and
Priority Review programs.
Experience the interactive Multimedia News Release here:
https://www.multivu.com/players/English/8058251-emd-serono-pfizer-bavencio-fda-approval/
BAVENCIO, a human anti-PD-L1 antibody, is the first FDA-approved
therapy for patients with mMCC.2 Metastatic MCC is a
rare and aggressive skin cancer, with fewer than half of patients
surviving more than one year and fewer than 20% surviving beyond
five years.3
"At the heart of this FDA approval is our drive to make a
meaningful difference for patients with hard-to-treat cancers like
metastatic Merkel cell carcinoma," said Belén Garijo, CEO
Healthcare and Member of the Executive Board of Merck KGaA,
Darmstadt, Germany. "BAVENCIO's
journey has included years of hard work – from the scientists who
discovered this molecule in our labs, to our alliance with Pfizer
and to the study participants and investigators worldwide. We are
grateful to all who have made it possible for us to bring this
important new treatment option to patients."
"Today is a significant milestone for people fighting metastatic
Merkel cell carcinoma, who until now have not had any options
beyond chemotherapy," said Albert
Bourla, Group President, Pfizer Innovative Health. "This
approval demonstrates the power of collaboration to accelerate
meaningful new choices for cancer patients."
"Merkel cell carcinoma is rarer than some of the more well-known
skin cancers, however, it's very aggressive and the proportion of
people who die from MCC is much higher than that of people with
melanoma," said Deborah S. Sarnoff,
MD, President of the Skin Cancer Foundation. "With this approval, I
believe there is new hope for people and their families touched by
this rare form of skin cancer."
The efficacy and safety of BAVENCIO was demonstrated in the
JAVELIN Merkel 200 trial, an open-label, single-arm, multi-center
study conducted in 88 patients with histologically confirmed
metastatic MCC whose disease had progressed on or after
chemotherapy administered for distant metastatic disease.
Sixty-five percent of patients were reported to have had one prior
anti-cancer therapy for metastatic MCC and 35% had two or more
prior therapies. The major efficacy outcome measures were confirmed
overall response rate (ORR) according to Response Evaluation
Criteria in Solid Tumors (RECIST) v1.1 as assessed by a blinded
independent central review committee (IRC) and IRC-assessed
duration of response.
The overall response rate (ORR) was 33% (95% confidence interval
[CI]: 23.3–43.8%).1 Eleven percent of patients
experienced a complete response (95% CI: 6.6-19.9%) and 22% of
patients experienced a partial response (95% CI: 13.5-31.7%). Tumor
responses were durable, with 86% of responses lasting for at least
six months (n=25).1 Forty-five percent of responses
lasted at least 12 months (n=13).1 Duration of response
ranged from 2.8 to over 23.3 months.
The warnings and precautions for BAVENCIO include
immune-mediated adverse reactions (such as pneumonitis,
hepatitis, colitis, endocrinopathies, nephritis and renal
dysfunction, and other adverse reactions), infusion-related
reactions and embryo-fetal toxicity. The most common adverse
reactions (reported in at least 20% of patients) included fatigue
(50%), musculoskeletal pain (32%), diarrhea (23%), nausea (22%),
infusion-related reactions (22%), rash (22%), decreased appetite
(20%) and peripheral edema (20%).1 For more information,
please see Important Safety Information for BAVENCIO
below.
BAVENCIO is designed to potentially engage both the adaptive and
innate immune systems. By binding to PD-L1, BAVENCIO is thought to
prevent tumor cells from using PD-L1 for protection against white
blood cells, such as T-cells, exposing them to anti-tumor
responses.1 BAVENCIO has been shown to induce
antibody-dependent cell-mediated cytotoxicity (ADCC) in
vitro.1
BAVENCIO is available for order now.
The alliance is committed to providing industry-leading patient
access and reimbursement support through its CoverOne™ program.
This program provides a spectrum of patient access and
reimbursement support services intended to help patients receive
appropriate access to BAVENCIO in the
United States. CoverOne may be reached by phone at
844-8COVER1 (844-826-8371) or online at www.CoverOne.com.
About JAVELIN Merkel 200
The efficacy and safety of BAVENCIO was demonstrated in the
JAVELIN Merkel 200 trial, an open-label, single-arm, multi-center
study conducted in 88 patients with histologically confirmed
metastatic MCC whose disease had progressed on or after
chemotherapy administered for distant metastatic disease.
Sixty-five percent of patients were reported to have had one prior
anti-cancer therapy for metastatic MCC and 35% had two or more
prior therapies. The major efficacy outcome measures were confirmed
overall response rate (ORR) according to Response Evaluation
Criteria in Solid Tumors (RECIST) v1.1 as assessed by a blinded
independent central review committee (IRC) and IRC-assessed
duration of response.
The trial excluded patients with autoimmune disease; medical
conditions requiring systemic immunosuppression; prior organ or
allogenic stem cell transplantation; prior treatment with
anti-PD-1, anti-PD-L1 or anti-CTLA-4 antibodies; CNS metastases;
infection with HIV, hepatitis B or hepatitis C; or ECOG performance
score greater than or equal to two. Patients received BAVENCIO 10
mg/kg as an intravenous infusion over 60 minutes every two weeks
until disease progression or unacceptable toxicity.
The international clinical development program for avelumab,
known as JAVELIN, involves at least 30 clinical programs, including
nine Phase III trials, and more than 4,000 patients across more
than 15 tumor types. In October 2016,
the alliance announced the European Medicines Agency accepted the
Marketing Authorisation Application for avelumab for the proposed
indication of metastatic MCC.
For full prescribing information and medication guide for
BAVENCIO, please see www.BAVENCIO.com or the FDA website.
IMPORTANT SAFETY INFORMATION and INDICATION
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% (21/1738) 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 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 was
reported in 0.9% (16/1738) of patients, including two (0.1%)
patients with Grade 5 and 11 (0.6 %) with Grade 3.
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 and permanently discontinue for life-threatening (Grade 4)
or recurrent (Grade 3) colitis upon re-initiation of BAVENCIO.
Immune-mediated colitis occurred in 1.5% (26/1738) 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% (8/1738)
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% (98/1738) 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 anti-hyperglycemics or
insulin in patients with severe or life-threatening (Grade 3 or
greater) hyperglycemia and resume treatment when metabolic control
is achieved. Type 1 diabetes mellitus without an alternative
etiology occurred in 0.1% (2/1738) 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% (1/1738) 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:
myocarditis with fatal cases, myositis, psoriasis, arthritis,
exfoliative dermatitis, erythema multiforme, pemphigoid,
hypopituitarism, uveitis, Guillain-Barré syndrome, and systemic
inflammatory response.
BAVENCIO can cause severe (Grade 3) or
life-threatening (Grade 4) infusion-related
reactions. Patients should be premedicated with an
antihistamine and acetaminophen prior to the first 4 infusions and
for subsequent doses 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%
(439/1738) of patients, including three (0.2%) patients with
Grade 4 and nine (0.5%) with Grade 3.
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 one 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 one 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,
greater than or equal to 20%) in patients with metastatic MCC
were fatigue (50%), musculoskeletal pain (32%), diarrhea (23%),
nausea (22%), infusion-related reactions (22%), rash (22%),
decreased appetite (20%), and peripheral edema (20%). The most
common adverse reaction requiring dose interruption was anemia.
Selected treatment-emergent laboratory abnormalities (all
grades, greater than or equal to 20%) in patients with metastatic
MCC were lymphopenia (49%), anemia (35%), increased aspartate
aminotransferase (34%), thrombocytopenia (27%). and increased
alanine aminotransferase (20%). Selected treatment-emergent
Grade 3-4 laboratory abnormalities (greater than or equal to
2%) were lymphopenia (19%), anemia (9%), hyperglycemia (7%),
increased alanine aminotransferase (5%), and increased lipase
(4%).
INDICATION
BAVENCIO is indicated 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 and duration of
response. Continued approval for this indication may be contingent
upon verification and description of clinical benefit in
confirmatory trials.
Please see full Prescribing Information and Medication
Guide.
About BAVENCIO® (avelumab)
BAVENCIO
is a human programmed death ligand-1 (PD-L1) blocking antibody
indicated in the US for the treatment of adults and pediatric
patients 12 years of age and older with metastatic Merkel cell
carcinoma.1 This indication is approved under
accelerated approval based on tumor response and duration of
response. Continued approval for this indication may be contingent
upon verification and description of clinical benefit in
confirmatory trials.
BAVENCIO is not approved in any market outside the US.
Alliance between Merck KGaA, Darmstadt, Germany, and Pfizer Inc., New York, US
Immuno-oncology is
a top priority for Merck KGaA, Darmstadt, Germany, and Pfizer Inc. The global strategic
alliance between Merck KGaA, Darmstadt, Germany, and Pfizer Inc., New York, US, enables the companies to benefit
from each other's strengths and capabilities and further explore
the therapeutic potential of avelumab, an anti-PD-L1 antibody
initially discovered and developed by Merck KGaA, Darmstadt,
Germany. The immuno-oncology
alliance will jointly develop and commercialize avelumab and
advance Pfizer's PD-1 antibody. The alliance is focused on
developing high-priority international clinical programs to
investigate avelumab as a monotherapy, as well as in combination
regimens, and is striving to find new ways to treat cancer.
About EMD Serono, Inc.
EMD Serono is the
biopharmaceutical business of Merck KGaA, Darmstadt, Germany – a leading science and technology
company – in the US and Canada,
focused exclusively on specialty care. For more than 40 years, the
business has integrated cutting-edge science, innovative products
and industry-leading patient support and access programs. EMD
Serono has deep expertise in neurology, fertility and
endocrinology, as well as a robust pipeline of potential therapies
in oncology, immuno-oncology and immunology as R&D focus areas.
Today, the business has 1,200 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
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Germany Press Releases are distributed by e-mail at the same time
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Website. Please go to www.emdgroup.com/subscribe to register
online, change your selection or discontinue this service.
Merck KGaA, Darmstadt, Germany,
is a leading science and technology company in healthcare, life
science and performance materials. Around 50,000 employees work to
further develop technologies that improve and enhance life – from
biopharmaceutical therapies to treat cancer or multiple sclerosis,
cutting-edge systems for scientific research and production, to
liquid crystals for smartphones and LCD televisions. In 2016, Merck
KGaA, Darmstadt, Germany,
generated sales of €15.0 billion in 66 countries.
Founded in 1668, Merck KGaA, Darmstadt, Germany, is the world's oldest pharmaceutical
and chemical company. The founding family remains the majority
owner of the publicly listed corporate group. Merck KGaA,
Darmstadt, Germany, holds the
global rights to the "Merck" name and brand except in the United States and Canada, where the company operates as EMD
Serono, MilliporeSigma and EMD Performance Materials.
About 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 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 @PfizerNews, LinkedIn, YouTube and
like us on Facebook at Facebook.com/Pfizer.
Pfizer Disclosure Notice
The information contained in
this release is as of March 23, 2017.
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 in the US for BAVENCIO for the
treatment of metastatic Merkel cell carcinoma (the Indication),
Pfizer's and Merck KGaA, Darmstadt, Germany's immuno-oncology alliance involving
anti-PD-L1 and anti-PD-1 therapies, 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 study commencement and completion dates and
regulatory submission 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
and when drug applications may be filed in any other jurisdictions
for the Indication or in any jurisdictions for any other potential
indications for BAVENCIO, combination therapies or other product
candidates; whether and when any such applications (including the
pending application for the Indication in the EU) 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 BAVENCIO, combination therapies or other 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, 2016, 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
- BAVENCIO Prescribing Information. Rockland, MA: EMD Serono Inc.; 2017.
- National Institutes of Health, U.S. National Library of
Medicine, Daily Med. Available at
https://dailymed.nlm.nih.gov/dailymed/advanced-search.cfm. Accessed
March 22, 2017.
- Lemos B, Storer B, Iyer J, et al. Pathologic Nodal Evaluation
Improves Prognostic Accuracy in Merkel Cell Carcinoma: Analysis of
5,823 Cases as the Basis of the First Consensus Staging System for
this Cancer. Journal of the American Academy of Dermatology.
2010;63(5):751–761.
Your
Contacts
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EMD Serono
Inc.
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Melissa
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+1 781 738
5673
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Relations
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+49 6151 72
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Pfizer Inc., New
York, USA
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8160
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SOURCE EMD Serono; Pfizer