Merck KGaA, Darmstadt, Germany, and Pfizer Initiate Phase III Trial to Evaluate Avelumab as First-line Treatment for Ovarian Cancer

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  • First Phase III trial evaluating the addition of an immune
    checkpoint inhibitor to standard of care in first-line ovarian cancer
  • New investigational regimen will evaluate avelumab in extending
    progression-free survival in treatment-naïve women

DARMSTADT, Germany & NEW YORK–(BUSINESS WIRE)–Merck KGaA, Darmstadt, Germany, and Pfizer (NYSE: PFE) today announced
the initiation of a Phase III study, JAVELIN Ovarian 100, to evaluate
the efficacy and safety of avelumab* in combination with, and/or as
follow-on (maintenance) treatment to, platinum-based chemotherapy in
patients with locally advanced or metastatic disease (Stage III or Stage
IV) with previously untreated epithelial ovarian cancer. JAVELIN Ovarian
100 is the first Phase III study evaluating the addition of an immune
checkpoint inhibitor to standard-of-care in first-line treatment for
this aggressive disease.

“In an early ongoing study, avelumab showed encouraging tumor response
rates in patients with recurrent or refractory ovarian cancer,” said
Alise Reicin, M.D., Head of Global Clinical Development at the biopharma
business of Merck KGaA, Darmstadt, Germany, which in the US and Canada
operates as EMD Serono. “Historically, ovarian cancer presents as an
advanced disease with poor survival rates. The hope is that avelumab can
change the natural history of the disease and potentially take the
survival rate beyond the current five year estimate.”

JAVELIN Ovarian 100 is an open-label, international, multi-center,
randomized (1:1:1) Phase III trial in treatment naïve patients with
locally advanced or metastatic ovarian cancer (Stage III or Stage IV).
This study is designed to evaluate the potential superiority of two
first-line therapies with avelumab and platinum-based chemotherapy
versus platinum-based chemotherapy alone, as assessed by
progression-free survival. The study will enroll approximately 950
patients, who will receive concurrent avelumab and chemotherapy,
avelumab following chemotherapy, or chemotherapy alone.

“Patients with ovarian cancer need additional treatment options. We
believe there could be synergistic activity in the combination of
avelumab and established treatments such as platinum-based
chemotherapy,” said Chris Boshoff, M.D., Ph.D., Head of Early
Development, Translational and Immuno-Oncology, Oncology in Pfizer
Global Product Development. “With two studies now underway of avelumab
in ovarian cancer, we look forward to receiving the results from these
trials and continuing to break ground in this hard-to-treat cancer.”

The alliance aims to build a strong foundation in ovarian cancer. In
December 2015, Merck KGaA, Darmstadt, Germany, and Pfizer announced the
initiation of an international Phase III study of avelumab as a
treatment for platinum-resistant/refractory ovarian cancer. As of May
2016, the complete JAVELIN clinical development program for avelumab
includes approximately 2,200 patients enrolled, being treated across
more than 15 tumor types.

For more information about avelumab, please visit www.powerofcombination.com.

*Avelumab is the proposed nonproprietary name for the anti-PD-L1
monoclonal antibody (MSB0010718C). Avelumab is under clinical
investigation and has not been proven to be safe and effective. There is
no guarantee any product will be approved in the sought-after indication
by any health authority worldwide.

References

1. GLOBOCAN2012. International Agency for Research on Cancer. World
Health Organization. http://globocan.iarc.fr/Default.aspx.
Last accessed June 1, 2016.

2. Ovarian Cancer Statistics. World Cancer Research Fund International. http://www.wcrf.org/int/cancer-facts-figures/data-specific-cancers/ovarian-cancer-statistics.
Last accessed June 1, 2016.

About Ovarian Cancer

Ovarian cancer causes more deaths than any other gynecologic cancer
globally. Each year, nearly a quarter of a million women will be
diagnosed with ovarian cancer worldwide.1 Women in Europe and Northern
America have the highest incidence rates of ovarian cancer.2 Patients
are said to have ‘platinum-resistant’ disease if the disease worsens
within 6 months of completing platinum-based chemotherapy. One quarter
of those who relapse after initial treatment, more than 4,300 women,
will have platinum-resistant cancer, the most difficult-to-treat form of
the disease.

About 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
potentially engage the innate immune system and induce
antibody-dependent cell-mediated cytotoxicity (ADCC). In November 2014,
Merck KGaA, Darmstadt, Germany, and Pfizer announced a strategic
alliance to co-develop and co-commercialize avelumab.

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 investigational
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 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
2015, Merck KGaA, Darmstadt, Germany, generated sales of € 12.85 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 operates as EMD Serono, MilliporeSigma and EMD
Performance Materials in the United States and Canada.

For further details and press materials about Merck KGaA, Darmstadt,
Germany products please visit http://www.emdgroup.com/emd/media/media_center_oncology.html.

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 healthcare products. Our global portfolio
includes medicines and vaccines, as well as many of the world’s
best-known consumer healthcare 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
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In addition, to learn more, follow us on Twitter at @Pfizer
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and like us on Facebook at Facebook.com/Pfizer.

Pfizer Disclosure Notice

The information contained in this release is as of July 6, 2016.
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
(MSB0010718C), including a potential indication for avelumab in
combination with, and as follow-on treatment to, platinum-based
chemotherapy in patients with previously untreated epithelial ovarian
cancer, 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, 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; 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 indications for avelumab,
combination therapies or other product candidates; 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 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, 2015, 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.

Contacts

Merck
Media:
Gangolf Schrimpf, +49 6151 72 9591
or
Investor
Relations:
+49 6151 72 3321
or
Pfizer, New York, USA
Media:
Sally
Beatty, +1-212-733-6566
or
Investor Relations:
Ryan
Crowe, +1-212-733-8160