Global Strategic Partners Merck and Pfizer Initiate Phase III Study with Avelumab* in Patients with Stage IIIb/IV Non-Small Cell Lung Cancer

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

Not intended for UK-based media

- First of several registration trials expected to start in 2015 for the
alliance between Merck and Pfizer
- Initiation and first patient treated in Phase III clinical study recruiting
across approximately 290 sites in more than 30 countries
- The primary endpoint of the study is overall survival (OS) in patients with
programmed death-ligand 1 positive (PD-L1+) stage IIIb/IV non-small cell lung cancer
(NSCLC) who have experienced disease progression after receiving a prior
platinum-containing doublet therapy

Merck and Pfizer today announced the initiation and first patient
treated in the international Phase III study (EMR 100070-004)
designed to assess the efficacy and safety of the investigational
cancer immunotherapy avelumab (MSB0010718C), compared with docetaxel,
in patients with stage IIIb/IV non-small cell lung cancer (NSCLC) who
have experienced disease progression after receiving a prior
platinum-containing doublet therapy.

The Phase III study is an open-label, multicenter, 1:1 randomized
clinical trial where patients with stage IIIb/IV NSCLC will receive
either avelumab or docetaxel, regardless of PD-L1 status.
Approximately 650 patients will participate across 290 sites in more
than 30 countries in North America, South America, Asia, Africa and
Europe. In North America, clinical trials on behalf of Merck will be
conducted by EMD Serono, the company's US and Canadian
biopharmaceutical businesses. The study is part of the JAVELIN
clinical trial program for avelumab.

The primary endpoint of the study is overall survival (OS) in
patients with programmed death-ligand 1 positive (PD-L1+) stage
IIIb/IV NSCLC who have experienced disease progression after
receiving a prior platinum-containing doublet therapy. Secondary
endpoints will be assessed across the entire study population
regardless of PD-L1 status and include OS; overall response rate
(ORR); progression-free survival (PFS); and patient-reported
outcomes.

"New and innovative treatment strategies are urgently needed to
improve overall survival for patients with NSCLC, and we are
investigating avelumab as a potential treatment option for patients
with this very difficult-to-treat disease," said Dr. Luciano
Rossetti, Global Head of R&D of Merck Serono. "The treatment of the
first patient in the Phase III trial is an important milestone for
our immuno-oncology alliance."

"This trial marks the first of several registration studies we are
planning to initiate this year together, and underscores our
commitment to accelerating the development of medications for
patients with cancer," said Dr. Mace Rothenberg, Senior Vice
President of Clinical Development and Medical Affairs and Chief
Medical Officer for Pfizer Oncology. "Through this alliance, we will
have the opportunity to combine the promising anti-PD-L1 antibody,
avelumab, with our combined portfolios of approved and
investigational oncology therapies, which may provide an exciting
opportunity to potentially broaden the use of immunotherapy for
patients with cancer."

The JAVELIN clinical trial program also includes an international
Phase II trial to investigate avelumab in patients with metastatic
Merkel cell carcinoma; an international Phase I trial to investigate
avelumab in patients with metastatic or locally advanced solid
tumors, and a Phase I trial to investigate avelumab in Japanese
patients with metastatic or locally advanced solid tumors with an
expansion part in Asian patients with gastric cancer. The Phase I
program for avelumab includes more than 840 patients treated across
multiple tumor types, including NSCLC, breast cancer, gastric cancer,
ovarian cancer, bladder cancer, melanoma and mesothelioma.

*Avelumab is the proposed International Nonproprietary Name (INN)
for the anti-PD-L1 monoclonal antibody (MSB0010718C)

About Non-Small Cell Lung Cancer

Globally, lung cancer is the most common cause of cancer-related
deaths in men and the second most common in women, responsible for
almost twice as many deaths as both breast and prostate cancer
combined[1]. NSCLC is the most common type of lung cancer, accounting
for 85 to 90 percent of all lung cancers[2]. Locally advanced and
metastatic disease account for approximately 35 to 40 percent[3]and
70 percent[4]of patients, respectively with NSCLC.

Avelumab Avelumab (also known as MSB0010718C) is an
investigational fully human anti-PD-L1 IgG1 monoclonal antibody. By
inhibiting PD-L1 interactions, avelumab is thought to enable the
activation of T-cells and the adaptive immune system. By retaining a
native Fc-region, avelumab is thought to engage the innate immune
system and induce antibody-dependent cell-mediated cytotoxicity
(ADCC). In November, 2014, Merck and Pfizer announced a strategic
alliance to co-develop and co-commercialize avelumab.

JAVELIN Clinical Trial Program for Avelumab

JAVELIN is an expansive international clinical trial program
exploring the use of PD-L1 inhibition with avelumab to treat multiple
types of cancer. The JAVELIN clinical trial program includes a Phase
III study designed to assess the efficacy and safety of avelumab
compared with docetaxel in patients with stage IIIb/IV NSCLC who have
experienced disease progression after receiving a prior
platinum-containing doublet therapy; an international Phase II
open-label multicenter trial to investigate the clinical activity and
safety of avelumab in patients with metastatic Merkel cell carcinoma;
an international Phase I open-label, multiple ascending dose trial to
investigate the safety, tolerability, pharmacokinetics, biological
and clinical activity in patients with metastatic or locally advanced
solid tumors; and a Phase I trial to investigate the tolerability,
safety, pharmacokinetics, biological, and clinical activity of
avelumab in Japanese patients with metastatic or locally advanced
solid tumors with an expansion part in Asian patients with gastric
cancer.

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 investigational
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 companies will
collaborate on up to 20 high priority immuno-oncology clinical
development programs, including combination trials, many of which are
expected to commence in 2015.

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 healthcare 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, Pfizer has
worked to make a difference for all who rely on us. To learn more,
please visit us at http://www.pfizer.com.

Merck

Merck of Darmstadt, Germany, is a leading company for innovative
and top-quality high-tech products in healthcare, life science and
performance materials. The company has six businesses -
Biopharmaceuticals, Consumer Health, Allergopharma, Biosimilars, Life
Science and Performance Materials - and generated sales of EUR 11.3
billion in 2014. Around 39,000 employees work in 66 countries to
improve the quality of life for patients, to foster the success of
customers and to help meet global challenges. Merck is the world's
oldest pharmaceutical and chemical company - since 1668, the company
has stood for innovation, business success and responsible
entrepreneurship. Holding an approximately 70% interest, the founding
family remains the majority owner of the company to this day. Merck
holds the global rights to the Merck name and brand. The only
exceptions are Canada and the United States, where the company
operates as EMD Serono, EMD Millipore and EMD Performance Materials.

All Merck press releases are distributed by e-mail at the same
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Pfizer Disclosure Notice

The information contained in this release is as of April 20, 2015.
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 Pfizer's
and Merck's immuno-oncology alliance involving anti-PD-L1 and
anti-PD-1 therapies, clinical development plans and a target
indication for avelumab (MSB0010718C) for treatment of patients with
stage IIIb/IV NSCLC who have experienced disease progression after
receiving a prior platinum-containing doublet therapy (the "Target
Indication") 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, the uncertainties inherent in research and development,
including the ability to meet anticipated clinical study commencement
and completion dates as well as the possibility of unfavorable study
results; risks associated with interim data, including the risk that
the final results of the Phase I study for avelumab and/or additional
clinical trials may be different from (including less favorable than)
the interim data results and may not support further clinical
development; 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 any potential
product candidates or combination therapies, including the Target
Indication; whether and when any such applications 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 any of such
product candidates or combination therapies, including the Target
Indication; 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, 2014 and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned "Risk Factors" and
"Forward-Looking Information That May Affect Future Results", as well
as in its subsequent reports on Form 8-K, all of which are filed with
the SEC and available at http://www.sec.gov and
http://www.pfizer.com.

References

1) American Cancer Society. (2011). Global Facts & Figures Second Edition.
Retrieved from:
http://www.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-027766.pdf
2) American Cancer Society. (2014). Lung Cancer (Non-Small Cell) [Fact sheet].
Retrieved from:
http://www.cancer.org/acs/groups/cid/documents/webcontent/003115-pdf.pdf
3) Blumenschein, G. R., Paulus, R., Curran, W. J., Robert, F., Fossella, F.,
Werner-Wasik, M., Herbst, R. S., Doescher, P. O., Choy, H., & Komaki, R. (2011). Phase
II study of cetuximab in combination with chemoradiation in patients with stage IIIA/B
non-small-cell lung cancer: RTOG 0324. Journal of clinical oncology: official journal
of the American Society of Clinical Oncology, 17, 2312-2318.
4) Wood, S. L., Pernemalm, M., Crosbie, P. A., & Whetton, A. D. (2013). The role
of the tumor-microenvironment in lung cancer-metastasis and its relationship to
potential therapeutic targets. Cancer treatment reviews, 4,558-566.

ots Originaltext: Merck and Pfizer
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Contact:
Merck
Media: Gangolf Schrimpf +49-6151-72-9591
Investor Relations: +49-6151-72-3321

Pfizer
Media: Sally Beatty +1-212-733-6566
Investor Relations: Ryan Crowe +1-212-733-8160