Merck and Pfizer Provide Update on Phase III JAVELIN Gastric 300 Study in Patients With Pre-Treated Advanced Gastric Cancer

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- Pivotal Phase III Javelin trial investigating avelumab as
third-line treatment for patients with unresectable, recurrent or
metastatic gastric cancer did not meet its pre-specified primary
endpoint of superior overall survival compared to chemotherapy
- First global trial of a checkpoint inhibitor versus an active
chemotherapy comparator rather than placebo in this hard-to-treat
patient population
- Safety profile was consistent with that observed in previously
reported studies of avelumab; no new safety signals were identified

Merck and Pfizer Inc. (NYSE: PFE) today announced that the Phase
III JAVELIN Gastric 300 trial did not meet its primary endpoint of
superior overall survival (OS) with single-agent avelumab* compared
with physician's choice of chemotherapy. The trial investigated
avelumab as a third-line treatment for unresectable, recurrent or
metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma
patients whose disease progressed following two prior therapeutic
regimens, regardless of programmed death ligand-1 (PD-L1) expression.
The safety profile of avelumab was consistent with that observed in
the overall JAVELIN clinical development program.

"Gastric cancer in the third-line setting is a particularly
hard-to-treat and heterogeneous disease, and importantly, this was
the first trial conducted with a checkpoint inhibitor compared to an
active chemotherapy comparator rather than placebo in a global
patient population," said Luciano Rossetti, M.D., Executive Vice
President, Global Head of Research & Development at the Biopharma
business of Merck. "Data from this study will provide valuable
information for physicians treating this late stage disease. We
remain committed to our ongoing gastric cancer program with avelumab
including the JAVELIN Gastric 100 study in the first-line switch
maintenance setting."

"Gastric cancer is a leading cause of cancer death globally with
clear unmet needs, and the results provide important insights as we
continue to investigate the role of avelumab for the treatment of
gastric cancer," said Chris Boshoff, M.D., Ph.D., Senior Vice
President and Head of Immuno-Oncology, Early Development and
Translational Oncology, Pfizer Global Product Development. "With
approvals for two cancers in 2017, our companies have made tremendous
progress with avelumab on behalf of patients this year, and we are
confident that our broad clinical development program in both
monotherapy and combinations across a range of cancers will continue
to bring new potential treatment options to patients."

The JAVELIN Gastric 300 data will be further examined in an effort
to better understand the results and will also be submitted for
presentation at an upcoming medical congress. The outcome of JAVELIN
Gastric 300 does not have any impact on current avelumab approvals.

JAVELIN Gastric 300 is a Phase III, multicenter, international,
randomized, open-label clinical trial investigating avelumab plus
best supportive care versus physician's choice of protocol-specified
chemotherapy (paclitaxel or irinotecan monotherapy) plus best
supportive care in patients with unresectable, recurrent or
metastatic gastric or GEJ adenocarcinoma whose disease has progressed
following two prior therapeutic regimens. The trial enrolled 371
patients from 147 sites in Asia, Australia, Europe, North America and
South America. The primary endpoint was OS.

The avelumab gastric clinical development program also includes
JAVELIN Gastric 100, a multicenter, randomized, open-label Phase III
study evaluating avelumab as first-line maintenance therapy following
induction chemotherapy in unresectable, locally advanced or
metastatic gastric or GEJ cancer. The trial will continue as planned.

*Avelumab is under clinical investigation for treatment of
gastric/GEJ cancer and has not been demonstrated to be safe and
effective for this indication. There is no guarantee that avelumab
will be approved for gastric/GEJ cancer by any health authority
worldwide.

About Gastric/Gastroesophageal Junction Cancer

Globally, gastric cancer is the fifth most common cancer but the
third most common cause of cancer death.[1],[2] In 2012, there were
approximately 950,000 new cases and 723,000 deaths worldwide.[3] Of
these cancers, 90 to 95 percent were adenocarcinomas.[4] Incidence
varies by country, with higher rates seen in Central/Eastern Europe,
Eastern Asia and South America.[5] Survival in advanced disease is
poor and generally less than one year.[6] Globally, there is no
recommended therapeutic approach for patients who progress after two
lines of therapy for recurrent or metastatic gastric cancer.

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.[7]-[9] Avelumab has also been shown
to induce NK cell-mediated direct tumor cell lysis via
antibody-dependent cell-mediated cytotoxicity (ADCC) in
vitro.[9]-[11] 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 (MCC) and (ii) patients with
locally advanced or metastatic urothelial carcinoma (UC) 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 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 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 combination
regimens, and is striving to find new ways to treat cancer.

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About Merck

Merck 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 2016, Merck
generated sales of EUR 15.0 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
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Pfizer Disclosure Notice

The information contained in this release is as of November 28,
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 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 http://www.sec.gov and http://www.pfizer.com.

References

1. Ferlay J, Soerjomataram I, Ervik M, Dikshit R, Eser S, Mathers C,
Rebelo M, Parkin DM, Forman D, Bray, F. GLOBOCAN 2012 v1.1,
Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11
[Internet]. Lyon, France: International Agency for Research on
Cancer; 2014. Available at: http://globocan.iarc.fr. Accessed:
November 2017.
2. International Agency for Research on Cancer. GLOBOCAN 2012
Available at:
http://globocan.iarc.fr/old/FactSheets/cancers/stomach-new.asp.
Accessed: November 2017.
3. Chapter 1, Cancer Worldwide. In: Stewart BW, Wild CP (eds). World
Cancer Report 2014: International Agency for Research on Cancer,
World Health Organization; 2014.
4. Waddell T et al. Ann Oncol 2013;24(Suppl 6):vi57-63.
5. International Agency for Research on Cancer. WHO. GLOBOCAN 2012:
Estimated Cancer Incidence, Mortality, and Prevalence Worldwide
in 2012 2012 [06 April 2015]. Available from:
http://globocan.iarc.fr/Default.aspx. Accessed: November 2017.
6. Shah MA. J Clin Oncol 2015;33:1760-9.
7. Dolan DE, Gupta S. PD-1 pathway inhibitors: changing the
landscape of cancer immunotherapy. Cancer Control.
2014;21(3):231-237.
8. Dahan R, Sega E, Engelhardt J, Selby M, Korman AJ, Ravetch JV.
Fc?Rs modulate the anti-tumor activity of antibodies targeting
the PD-1/PD-L1 axis.Cancer Cell. 2015;28(3):285-295.
9. 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):1148-1157.
10. Kohrt HE, Houot R, Marabelle A, et al. Combination strategies to
enhance antitumor ADCC. Immunotherapy. 2012;4(5):511-527.
11. Hamilton G, Rath B. Avelumab: combining immune checkpoint
inhibition and antibody-dependent cytotoxicity. Expert Opin Biol
Ther. 2017;17(4):515-523.

Contacts

Merck

Media

Friederike Segeberg

+49-6151-72-6328

Investor Relations

+49-6151-72-3321

Pfizer

Media (US)

Sally Beatty

+1-212-733-6566

Investor Relations

Ryan Crowe

+1-212-733-8160

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