Merck and Pfizer to Present Data Highlighting Potential of Avelumab in Challenging Cancers at ASCO 2017

Darmstadt, Germany and New York (ots/PRNewswire) -

Not intended for US, Canada and UK-based media

- A total of 13 abstracts across seven hard-to-treat cancers
highlight the progress of avelumab as a monotherapy and potential
novel combination treatment option
- New data in metastatic Merkel cell carcinoma and previously treated
metastatic urothelial carcinoma, following recent US FDA
accelerated approvals

Merck and Pfizer today announced that 13 avelumab* abstracts
across seven challenging tumor types will be featured at the 53rd
American Society of Clinical Oncology (ASCO) Annual Meeting held June
2-6, 2017 in Chicago, IL. Key presentations include data for avelumab
in first-line metastatic Merkel cell carcinoma (mMCC) and in
previously treated metastatic urothelial carcinoma (UC), as well as
results from the Phase Ib trial investigating avelumab in combination
with the tyrosine kinase inhibitor axitinib, in advanced renal cell
carcinoma (RCC).

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"Our ASCO presence adds to what has already been a momentous year
for the alliance, coming shortly after the US FDA granted two
accelerated approvals for avelumab," said Luciano Rossetti, M.D.,
Executive Vice President, Global Head of Research & Development at
the biopharma business of Merck, which in the US and Canada operates
as EMD Serono. "We're particularly excited to share the latest
avelumab data in both metastatic Merkel cell carcinoma in the
first-line setting and previously treated metastatic urothelial
carcinoma with the cancer community."

"Our data at ASCO this year underscore the potential of avelumab
as a monotherapy treatment, as well as part of combination regimens,"
said Chris Boshoff, M.D., PhD, Senior Vice President and Head of
Immuno-Oncology, Early Development, Translational Oncology, Pfizer
Global Product Development. "Now with accelerated approvals in two
indications for avelumab in the US, we are entering the next chapter
of our clinical development program to provide meaningful new
treatment options for patients who need them most."

Highlights of avelumab data at ASCO 2017 include the following:

- Preliminary data from the ongoing JAVELIN Merkel 200 trial, an
open-label, multicenter study conducted in first-line mMCC
investigating avelumab in patients who had no prior systemic
treatment for mMCC, will be presented for the first time at a
medical congress.
- Data from a pooled analysis of two metastatic UC cohorts of the
JAVELIN Solid Tumor trial, a Phase Ib, open-label, single-arm,
multicenter study of avelumab in the treatment of various solid
tumors, will be presented.
- An oral presentation of results from the JAVELIN Renal 100 trial, a
Phase Ib, open-label study evaluating the clinical activity and
safety of the combination of avelumab and axitinib for the
first-line treatment of advanced RCC.
- Beyond mMCC, metastatic UC and RCC, the Merck-Pfizer Alliance will
also showcase avelumab abstracts in non-small cell lung cancer,
metastatic castrate-resistant prostate cancer, locally advanced
squamous cell carcinoma of the head and neck and relapsed or
refractory diffuse large B-cell lymphoma, as well as updated safety
data in solid tumors.

The alliance's rapidly accelerating JAVELIN clinical development
program now involves at least 30 clinical programs, including nine
Phase III trials, and more than 5,200 patients across more than 15
tumor types. Results from JAVELIN program trials have supported two
FDA accelerated approvals in 2017.

A list of accepted avelumab abstracts is included below. The
abstracts are also available on the ASCO website
(https://am.asco.org/).

Abstract ID / Presentation
Title Lead Author Poster No. Date / Time
Session
Oral Presentations

Renal Cell Choueiri TK 4504 Monday, June 5
Genitourinary
Carcinoma 8:00-11:00 a.m.
(Nonprostate) Cancer
(JAVELIN Renal
100)

First-line
avelumab +
axitinib therapy
in patients with
advanced renal
cell carcinoma:
results from a
phase 1b trial

Poster Sessions

Head and Neck Lee NY TPS6093 Monday, June 5
Head and Neck Cancer
Cancer (TiP) 1:15-4:45 p.m.
(JAVELIN Head and
Neck 100)

JAVELIN Head and
Neck 100: a phase
3 trial of
avelumab in
combination with
chemoradiotherapy
(CRT) vs CRT for
1st-line
treatment of
locally advanced
squamous cell
carcinoma of the
head and neck (LA
SCCHN)

Lymphoma (TiP) Chen R TPS7575 Monday, June 5
Hematologic
(JAVELIN DLBCL) 8:00-11:30 a.m.
Malignancies-Lymphoma

and Chronic Lymphocytic
Phase 1b/3 study
Leukemia
of avelumab-based
combination
regimens in
patients (pts)
with relapsed or
refractory
diffuse large
B-cell lymphoma
(R/R DLBCL)

Merkel Cell D'Angelo SP 9530 Saturday, June 3
Melanoma/Skin Cancers
Carcinoma 1:15-4:45 p.m.
(JAVELIN Merkel
200)

First-line
avelumab
treatment in
patients with
metastatic Merkel
cell carcinoma:
preliminary data
from an ongoing
study

Merkel Cell Shapiro I 9557 Saturday, June 3
Melanoma/Skin Cancers
Carcinoma 1:15-4:45 p.m.
(JAVELIN Merkel
200)

Exploratory
biomarker
analysis in
patients with
chemotherapy-
refractory metastatic
Merkel cell
carcinoma treated
with avelumab

Non-Small Cell Gulley JL 9086 Saturday, June 3
Lung Cancer-Non-Small
Lung Cancer 8:00-11:30 a.m.
Cell Metastatic
(JAVELIN Solid
Tumor)

Exposure-response
and PD-L1
expression
analysis of
second-line
avelumab in
patients with
advanced NSCLC:
data from the
JAVELIN Solid
Tumor trial

Pan-Tumor Kelly K 3059 Monday, June 5
Developmental
(JAVELIN Solid 8:00-11:30 a.m.
Therapeutics-
Tumor)
Immunotherapy

Safety profile of
avelumab in
patients with
advanced solid
tumors: a JAVELIN
pooled analysis
of phase 1 and 2
data

Prostate Cancer Fakhrejahani F 5037 Monday, June 5
Genitourinary
(JAVELIN Solid 1:15-4:45 PM
(Prostate) Cancer
Tumor)

Avelumab in
metastatic
castration-resist
ant prostate
cancer (mCRPC)

Renal Cell Choueiri TK TPS4594 Sunday, June 4
Genitourinary
Carcinoma 8:00-11:30 a.m.
(Nonprostate)
(JAVELIN Renal
101)

Avelumab plus
axitinib vs
sunitinib as
first-line
treatment of
advanced renal
cell carcinoma:
phase 3 study
(JAVELIN Renal
101)

Urothelial Apolo AB 4528 Sunday, June 4
Genitourinary
Carcinoma 8:00-11:30 a.m.
(Nonprostate) Cancer
(JAVELIN Solid
Tumor)

Updated efficacy
and safety of
avelumab in
metastatic
urothelial
carcinoma: pooled
analysis from 2
cohorts of the
phase 1b JAVELIN
Solid Tumor study

Publications

Merkel Cell Bharmal M e21070
Carcinoma
(JAVELIN Merkel
200)

Non-progression
during avelumab
treatment is
associated with
clinically
relevant
improvements in
health-related
quality of life
in patients with
Merkel cell
carcinoma

Merkel Cell Kaufman HL e21065
Carcinoma
(JAVELIN Merkel
200)

Patient
experiences with
avelumab vs
chemotherapy for
treating Merkel
cell carcinoma:
results from
protocol-specified
qualitative
research

Non-Small Cell Feng Z e20581
Lung Cancer
(JAVELIN Solid
Tumor)

Comparative study
of two PD-L1
expression assays
in patients with
non-small cell
lung cancer
(NSCLC)

*Avelumab is under clinical investigation for treatment of NSCLC,
RCC, DLBCL, SSCHN and mCRPC and has not been demonstrated to be safe
and effective for these indications. There is no guarantee that
avelumab will be approved for NSCLC, RCC, DLBCL, SSCHN and mCRPC by
any health authority worldwide.

About Avelumab

Avelumab is a human antibody specific for a protein called PD-L1,
or programmed death

ligand-1. Avelumab is designed to potentially engage both the
adaptive and innate immune systems. By binding to PD-L1, avelumab 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. Avelumab 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 avelumab.

Indications

The US Food and Drug Administration (FDA) granted accelerated
approval for avelumab (BAVENCIO®) for the treatment of (i) metastatic
Merkel cell carcinoma (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. Continued approval for these
indications may be contingent upon verification and description of
clinical benefit in confirmatory trials. Avelumab is not approved for
any indication in any market outside the US.

Important Safety Information

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 avelumab 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 Inc. 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 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.

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Pfizer Disclosure Notice

The information contained in this release is as of May 17, 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), 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 drug applications may be filed in any
jurisdictions for potential indications for BAVENCIO, combination
therapies or other product candidates; whether and when any such
applications (including the pending application for BAVENCIO for
metastatic Merkel cell carcinoma 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
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