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

PR60216

DARMSTADT, Germany and NEW YORK, Apr. 20, 2015 /PRN=KYODO JBN/ --

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 time they become

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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

American Cancer Society. (2011). Global Facts & Figures Second Edition.  

Retrieved from:

http://www.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-027766.pdf

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

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.

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.

SOURCE: Merck and Pfizer