Two Year Update of Pivotal JAVELIN Merkel 200 Trial Shows Continued Durable Responses with BAVENCIO® (avelumab)

Chicago (ots/PRNewswire) -

Not intended for US, Canada and UK-based media

- Two-year follow-up data on meaningful durable response, overall
survival (OS) and progression-free survival (PFS) to be presented
in patients with metastatic Merkel cell carcinoma (mMCC), a rare
and aggressive type of skin cancer

Merck and Pfizer today announced that updated efficacy and safety
data from the pivotal JAVELIN Merkel 200 trial of BAVENCIO®
(avelumab) in patients with metastatic Merkel cell carcinoma (mMCC),
will be presented as an oral abstract session at the 54th American
Society of Clinical Oncology (ASCO) Annual Meeting on Monday, June 4
from 10:12-10:24 a.m. CDT in Chicago, IL. At this two year follow-up
update of the pivotal study, BAVENCIO continues to demonstrate
clinically meaningful durable responses and stable rates of
progression-free survival (PFS) and overall survival (OS) from
previous analyses in patients who responded to this treatment.
Clinical activity was observed across all patient subgroups,
irrespective of PD-L1 expression in tumor tissue or Merkel cell
polyomavirus status. The safety profile for BAVENCIO in this trial
has not changed with longer follow-up and remains consistent with
that observed in the overall JAVELIN clinical development program.

"These efficacy and safety results build upon the data that
supported our FDA approval," said Luciano Rossetti, M.D., Executive
Vice President, Global Head of Research & Development at the
Biopharma business of Merck. "Alongside our other data at ASCO, this
two-year analysis is a significant advance in our understanding of
the utility of BAVENCIO in MCC patients."

In JAVELIN Merkel 200 - an open-label, single-arm Phase II study -
patients with histologically confirmed mMCC whose disease had
progressed on or after chemotherapy administrated for distant
metastatic disease received BAVENCIO 10 mg/kg intravenously every two
weeks until disease progression or unacceptable toxicity.
Eighty-eight patients were followed for a median of 29.2 months
(range 24.8-38.1 months). The confirmed overall response rate (ORR)
of 33% (95% confidence interval [CI] 23.3-43.8; complete response in
11.4%) remained unchanged from previous analyses reported at both one
year and 18 months. Responses remained ongoing in 19 of 29 patients
who responded to treatment, including 12 patients whose duration of
response exceeded two years. Durable responses led to stable rates of
PFS (29% at 12 months, 29% at 18 months and 26% at 24 months). Median
OS was 12.6 months (95% CI 7.5-17.1) and the two-year OS rate was 36%
(50% at 12 months and 39% at 18 months). With a minimum follow-up of
two years, no new safety signals were identified for BAVENCIO and was
consistent with prior reports. Sixty-seven patients (76.1%) had a
treatment related adverse event (TRAE), 10 patients (11.4%) had a
Grade 3 or less TRAE and 20 patients (22.7%) had an immune-related
adverse event. No treatment-related deaths occurred.

"These results represent a key milestone for patients with mMCC,
as chemotherapy has historically been the only treatment option for
this devastating disease," said Chris Boshoff, M.D., Ph.D., Senior
Vice President and Head of Immuno-Oncology, Early Development and
Translational Oncology, Pfizer Global Product Development. "These
data, alongside the additional real-world data which are also being
presented at ASCO, strengthen our confidence in BAVENCIO as a
treatment option for this rare and aggressive skin cancer."

In addition to these updated JAVELIN Merkel 200 data, results from
a global expanded access program for BAVENCIO as a second-line
treatment for patients with mMCC will be presented. These data will
be presented during a poster session on Monday, June 4 from

1:15-4:45 p.m. CDT.

The alliance's JAVELIN clinical development program involves at
least 30 clinical programs, including seven Phase III trials, and
nearly 8,300 patients across more than 15 tumor types.

*BAVENCIO® (avelumab) was first approved in the US in 2017 by the
US Food and Drug Administration (FDA) for the treatment of adults and
pediatric patients 12 years and older with metastatic Merkel cell
carcinoma (mMCC). In addition to the FDA accelerated approval in
mMCC, avelumab is also approved in the US under accelerated approval
for the treatment of 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 are 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.

About JAVELIN Merkel 200

JAVELIN Merkel 200 is an international, multicenter, open-label,
single-arm Phase II study of BAVENCIO conducted in 88 patients with
metastatic MCC. Patients in this study were generally elderly (median
age was 72.5 years, range 33-88 years) and pre-treated, with at least
one line of chemotherapy (one [59.1%], two [29.5%] or three or more
[11.4%] previous treatments). Patients received BAVENCIO 10 mg/kg
intravenously once every two weeks. The protocol-defined analysis set
for efficacy and safety consisted of all patients who received at
least one dose of study treatment. The cut-off date for the planned
primary analysis was six months after start of study treatment of the
last patient. The primary endpoint of the study was confirmed best
overall response according to RECIST v1.1 and assessed by an
independent review committee. Secondary endpoints were duration of
response, PFS, OS, response status by RECIST at six and 12 months,
safety and tolerability, pharmacokinetics, and immunogenicity of
BAVENCIO.

About Avelumab

Avelumab is a human anti-programmed death ligand-1 (PD-L1)
antibody. Avelumab 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, avelumab has been shown to
release the suppression of the T cell-mediated antitumor immune
response in preclinical models.[2]-[4] Avelumab has also been shown
to induce NK cell-mediated direct tumor cell lysis via
antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro.[4]-[6]
In November 2014, Merck and Pfizer announced a strategic alliance to
co-develop and co-commercialize avelumab.

Approved Indications in the US

The FDA granted accelerated approval for avelumab (BAVENCIO®) for
the treatment of (i) adults and pediatric patients 12 years and older
with metastatic Merkel cell carcinoma (mMCC) and (ii) patients with
locally advanced or metastatic urothelial carcinoma (mUC) 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. These indications are 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 Approval 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 mUC include fatigue, musculoskeletal pain, diarrhea,
nausea, infusion-related reaction, peripheral edema, decreased
appetite/hypophagia, urinary tract infection and rash.

About the 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 avelumab, an anti-PD-L1 antibody
initially discovered and developed by Merck. The immuno-oncology
alliance is jointly developing and commercializing avelumab and
advancing 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.

All Merck Press Releases are distributed by e-mail at the same
time they become available on the Merck Website. Please go to
http://www.merckgroup.com/subscribe to register online, change your
selection or discontinue this service.

About Merck

Merck is a leading science and technology company in healthcare,
life science and performance materials. Almost 53,000 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 2017, Merck
generated sales of EUR 15.3 billion in 66 countries.

Founded in 1668, Merck is the world's oldest pharmaceutical and
chemical company. The founding family remains the majority owner of
the publicly listed corporate group. Merck, 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.

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
http://www.pfizer.com. In addition, to learn more, please visit us at
http://www.pfizer.com and follow us on Twitter at @Pfizer (http://cts
.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Ftwitter.com%2F
pfizer&esheet=51356409&newsitemid=20160606005771&lan=en-US&anchor=%40
Pfizer&index=4&md5=e87fe5c6856741051dc884b6867e3ffa) and @Pfizer_News
(http://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Ftwi
tter.com%2Fpfizer_news&esheet=51356409&newsitemid=20160606005771&lan=
en-US&anchor=%40Pfizer_News&index=5&md5=cf5e63756f6ab5c12fc077e5e9006
8e3), LinkedIn (https://www.linkedin.com/company/pfizer) YouTube and
like us on Facebook at Facebook.com/Pfizer (http://cts.businesswire.c
om/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.facebook.com%2FPfizer&esh
eet=51356409&newsitemid=20160606005771&lan=en-US&anchor=Facebook.com%
2FPfizer&index=7&md5=288d5bd99c7df784e0916061c5cfd713).

Pfizer Disclosure Notice

The information contained in this release is as of June 4, 2018.
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 avelumab,
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
avelumab; 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
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 jurisdictions for potential
indications for avelumab, combination therapies or other product
candidates; whether and when regulatory authorities in any
jurisdictions where applications are pending or may be submitted for
avelumab, 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
avelumab, 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 http://www.sec.gov and http://www.pfizer.com.

References

1. Nghiem P. Two-year efficacy and safety update from JAVELIN Merkel
200 part A: a phase 2 study of avelumab in metastatic Merkel cell
carcinoma progressed on chemotherapy. Abstract 9507. To be
presented at ASCO 2018, June 1-4, 2018. Chicago, IL.
2. Dolan DE, Gupta S. PD-1 pathway inhibitors: changing the landscape
of cancer immunotherapy. Cancer Control 2014;21(3):231-7.
3. Dahan R, Sega E, Engelhardt J, et al. Fc?Rs modulate the
anti-tumor activity of antibodies targeting the PD-1/PD-L1 axis.
Cancer Cell 2015;28(3):285-95.
4. Boyerinas B, Jochems C, Fantini M, et al. Antibody-dependent
cellular cytotoxicity activity of a novel anti-PD-L1 antibody
avelumab (MSB0010718C) on human tumor cells. Cancer Immunol Res
2015;3(10):1148-57.
5. Kohrt HE, Houot R, Marabelle A, et al. Combination strategies to
enhance antitumor ADCC. Immunotherapy 2012;4(5):511-27.
6. Hamilton G, Rath B. Avelumab: combining immune checkpoint
inhibition and antibody-dependent cytotoxicity. Expert Opin Biol
Ther 2017;17(4):515-23.

Contacts

Merck

Media

Friederike Segeberg

+49-6151-72-6328

Investor Relations

+49-6151-72-3321

Pfizer

Media (US)

Jessica Smith

+1-212-733-6213

Investor Relations

Ryan Crowe

+1-212-733-8160

(Logo:
http://mma.prnewswire.com/media/611425/Merck_Pfizer_Logo.jpg )

ots Originaltext: Merck KGaA
Im Internet recherchierbar: http://www.presseportal.de

Original-Content von: Merck KGaA, übermittelt durch news aktuell