FDA Grants Approval for BAVENCIO(R) (avelumab), the First
Immunotherapy Approved for Metastatic Merkel Cell Carcinoma
- Only FDA-approved treatment for metastatic Merkel cell
carcinoma, a rare and aggressive skin cancer
- First indication for BAVENCIO, a human anti-PD-L1 antibody
PR Newswire
ROCKLAND, Mass. and NEW YORK, March 23, 2017
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(R) (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(TM) 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(R) (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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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 EUR15.0 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(R)
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
1. BAVENCIO Prescribing Information. Rockland, MA: EMD Serono Inc.; 2017.
2. 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.
3. 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
EMD Serono Inc.
Media Melissa Lauer +1 781 738 5673
Investor Relations +49 6151 72 3321
Pfizer Inc., New York, USA
Media Sally Beatty +1 212 733 6566
Investor Relations Ryan Crowe +1 212 733 8160
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/fda-grants-approval-for-bavencio-avelumab-the-first-immunotherapy-approved-for-metastatic-merkel-cell-carcinoma-300428838.html
SOURCE EMD Serono; Pfizer
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(END) Dow Jones Newswires
March 23, 2017 17:45 ET (21:45 GMT)
Copyright (c) 2017 Dow Jones & Company, Inc.
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