Bavencio (avelumab) Approved for Merkel Cell Carcinoma in Japan
Bavencio (avelumab) Approved for Merkel Cell Carcinoma in Japan
PR70315
DARMSTADT, Germany and NEW YORK, Sept. 27, 2017 /PRNewswire=KYODO JBN/ --
Not intended for US, Canadian and UK-based media
- First-ever treatment indicated for curatively unresectable Merkel cell
carcinoma (MCC) and first anti-PD-L1 to be available in Japan
- Japanese Ministry of Health, Labour and Welfare (MHLW) decision based
on Javelin Merkel 200 study, the largest registrational trial for an
immunotherapy in MCC
- First Asian approval for BAVENCIO follows approvals in the US
and Europe
Merck and Pfizer Inc. (NYSE: PFE) today announced that the Japanese
Ministry of Health, Labour and Welfare (MHLW) has approved
BAVENCIO(R) (avelumab, genetically recombinant Injection 200mg/mL for
intravenous use) as the first and only treatment indicated for curatively
unresectable Merkel cell carcinoma (MCC), a rare and aggressive skin cancer, in
Japan.
(Logo: http://mma.prnewswire.com/media/477506/Merck_Pfizer_Logo.jpg)
"Today marks the approval of the first-ever treatment indicated for Merkel
cell carcinoma in Japan, making this a significant milestone for patients
living with a devastating type of skin cancer," said Luciano Rossetti, M.D.,
Executive Vice President, Global Head of Research & Development at the
biopharma business of Merck. "This decision by the MLHW also signifies the
first approval of an anti-PD-L1 in Japan."
"This is the fifth approval for Bavencio in 2017 and the first in an Asian
market," said Andreas Penk, M.D., Regional President Oncology International
Developed Markets, Pfizer Oncology. "Today's announcement demonstrates our
continued determination to provide access to our immunotherapy for people
around the world living with hard-to-treat cancers such as Merkel cell
carcinoma."
MCC is a designated rare disease in Japan and is estimated to affect fewer
than 100 patients.[2],[3] BAVENCIO previously received Orphan Drug Designation
from the MHLW in December 2016.
"Until now, there were no licensed treatments for MCC in Japan," said Dr
Naoya Yamazaki, Chief of the Department of Dermatologic Oncology, National
Cancer Center Hospital, Japan. "As a cancer that progresses quickly and has,
for so many, a poor prognosis, today's approval is a huge step forward for
people impacted by this destructive disease."
This approval is based on data from JAVELIN Merkel 200, an international,
multicenter, single-arm, open-label, Phase II study in patients with metastatic
MCC.[1]
The JAVELIN Merkel 200 study is the largest registrational clinical trial
for an immunotherapy in metastatic MCC. The results of this study were
previously presented at the June 2016 American Society of Clinical Oncology
annual congress and published in the October 2016 edition of Lancet Oncology.
The MHLW's decision follows BAVENCIO's recent approval by the European
Commission on September 18, 2017, as a monotherapy for the treatment of adult
patients with metastatic MCC (mMCC). BAVENCIO was also granted marketing
authorization by Swissmedic on September 05, 2017, for the treatment of
patients with mMCC, whose disease has progressed after at least one
chemotherapy treatment. Earlier this year, the US Food and Drug Administration
(FDA) granted accelerated approval* for BAVENCIO for the treatment of mMCC and
patients with locally advanced or metastatic urothelial carcinoma (UC) who have
disease progression during or following platinum-containing chemotherapy.
The clinical development program for BAVENCIO, known as JAVELIN, involves
at least 30 clinical programs and more than 6,300 patients evaluated across
more than 15 different tumor types. In addition to mMCC, these cancers include
breast, gastric/gastro-esophageal junction, head and neck, Hodgkin's lymphoma,
melanoma, mesothelioma, non-small cell lung, ovarian, renal cell carcinoma and
urothelial carcinoma.
About Merkel Cell Carcinoma
MCC is a rare and aggressive disease in which cancer cells form in the top
layer of the skin, close to nerve endings.[4],[5] MCC, which is also known as
neuroendocrine carcinoma of the skin or trabecular cancer, often starts in
those areas of skin that are most often exposed to the sun, including the head
and neck, and arms.[4],[6] Risk factors for MCC include sun exposure and
infection with Merkel cell polyomavirus. Caucasian males older than 50 are at
increased risk.[4],[6] MCC is often misdiagnosed as other skin cancers and
grows at an exponential rate on chronically sun-damaged skin.[6-8] Current
treatment options for MCC include surgery, radiation and
chemotherapy.[5] Treatment for metastatic or Stage IV MCC is generally
palliative.[5]
About JAVELIN Merkel 200
The efficacy and safety of BAVENCIO was demonstrated in the JAVELIN Merkel
200 trial, a Phase II, open-label, single-arm, multicenter study, in metastatic
MCC.[1] The trial excluded patients with active or a history of central nervous
system (CNS) metastasis, prior treatment with anti-PD-1, anti-PD-L1, or
anti-CTLA-4 antibodies, active or a history of autoimmune disease, a history of
other malignancies within the last 5 years, organ transplant, and conditions
requiring therapeutic immune suppression or active infection with HIV, or
hepatitis B or C. Patients received BAVENCIO 10 mg/kg as an intravenous
infusion over 60 minutes every 2 weeks until disease progression or
unacceptable toxicity.
The JAVELIN Merkel 200 study is the largest registrational clinical trial
for an immunotherapy in metastatic MCC. The results of this study were
previously presented at the June 2016 American Society of Clinical Oncology
annual congress and published in the October 2016 edition of Lancet Oncology.
About BAVENCIO
BAVENCIO(R) (avelumab) is a human antibody specific for a protein called
PD-L1, or programmed death ligand-1. 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. BAVENCIO
has been shown to induce antibody-dependent cell-mediated cytotoxicity (ADCC)
in vitro. In November 2014, Merck and Pfizer announced a strategic alliance to
co-develop and co-commercialize BAVENCIO.
*Indications in the US[9]
The US Food and Drug Administration (FDA) granted accelerated approval for
BAVENCIO for the treatment of (i) mMCC in adults and pediatric patients 12
years and older and (ii) patients with locally advanced or metastatic
urothelial carcinoma (UC) who have disease progression during or following
platinum-containing chemotherapy, or who have disease progression within
12 months of neoadjuvant or adjuvant treatment with platinum-containing
chemotherapy. These indications were approved under accelerated approval based
on tumor response rate and duration of response. Continued approval for these
indications may be contingent upon verification and description of clinical
benefit in confirmatory trials.
Important Safety Information from the US FDA Approved Label
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.
Common adverse reactions (reported in at least 20% of patients) in patients
treated with BAVENCIO for mMCC and patients with locally advanced or metastatic
UC include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related
reaction, peripheral edema, decreased appetite/hypophagia, urinary tract
infection and rash.
About Merck-Pfizer Alliance
Immuno-oncology is a top priority for Merck and Pfizer. The global
strategic alliance between Merck and Pfizer enables the companies to benefit
from each other's strengths and capabilities and further explore the
therapeutic potential of BAVENCIO, an investigational anti-PD-L1 antibody
initially discovered and developed by Merck. The immuno-oncology alliance will
jointly develop and commercialize BAVENCIO and advance Pfizer's PD-1 antibody.
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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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
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Founded in 1668, Merck is the world's oldest pharmaceutical and chemical
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company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.
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Pfizer Disclosure Notice
The information contained in this release is as of September 27, 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 a new indication in Japan for the treatment of curatively
unresectable Merkel cell carcinoma, the Merck-Pfizer 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 any other
drug applications may be filed in any jurisdictions for potential indications
for BAVENCIO, combination therapies or other product candidates; whether and
when regulatory authorities in any other jurisdictions where applications are
pending or may be submitted for BAVENCIO, combination therapies or other
product candidates may approve any such applications, 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 [http://www.pfizer.com
].
References
1) Kaufman HL et al., Avelumab in patients with chemotherapy-refractory
metastatic Merkel cell carcinoma: a multicentre, single-group, open-label,
phase 2 trial. Lancet Oncol 2016; 17(10): 1374-85.
2) Ishihara K, et al., Statistical profiles of malignant melanoma and other
skin cancers in Japan: 2007 update. Int J Clin Oncol 2008;13(1): 33-41.
3) Total number of patients, by each basic disease category, Chart 96,
2014, Department of Statistic and Information, Minister of Health, Labour and
Welfare's Secretariat. Available
from: https://www.e-stat.go.jp/SG1/estat/eStatTopPortal.do. Accessed September
2017.
4) Schadendorf D et al. Merkel cell carcinoma: epidemiology, prognosis,
therapy and unmet medical needs. European Journal of Cancer 2017;71;53-69
5) American Cancer Society. What is Merkel cell carcinoma? Available
from: http://www.cancer.org/cancer/skincancer-merkelcell/detailedguide/skin-canc
er-merkel-cell-carcinoma-what-is-merkel-cell-carcinoma . Accessed September
2017.
6) Nghiem P. Systematic literature review of efficacy, safety and
tolerability outcomes of chemotherapy regimens in patients with metastatic
Merkel cell carcinoma. Future Oncology 2017;13(14):1263-1279.
7) Heath M, Jaimes N and Lemos B. Clinical characteristics of Merkel cell
carcinoma at diagnosis in 195 patients: the AEIOU features. J Am Acad Dermatol
2008;58:375-81. http://www.pnlab.org/clinical/documents/ClinCharacteristics.pdf.
Accessed September 2017.
8) NCCN Merkel Cell Carcinoma Guidelines version I. 2017.
9) BAVENCIO Prescribing Information. 2017. Rockland, MA: EMD Serono Inc.
Contacts
Merck
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Source: Merck
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