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

PR68608

DARMSTADT, Germany and NEW YORK, May 18, 2017 /PRNewswire=KYODO JBN/--

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).

     (Logo: http://mma.prnewswire.com/media/477506/Merck_Pfizer_Logo.jpg )

"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.  

                                      

                             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-refr                          

actory 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(R)) 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.

All Merck Press Releases are distributed by e-mail at the same time they become

available on the Merck Website. Please go to

http://www.merckgroup.com/subscribe to register online, change your selection

or discontinue this service.

For further details and press materials about Merck in oncology please visit

http://www.merckgroup.com/en/media/media_center_oncology.html

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(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 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 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, we have worked to make a difference for all who rely on us. We

routinely post information that may be important to investors on our website at

http://www.pfizer.com. In addition, to learn more, please visit us at

http://www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News,

LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

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 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.

Your Contacts

Merck

Media

Gangolf Schrimpf

+49-6151-72-9591

Investor Relations                      

+49-6151-72-3321

Pfizer

Media (US)

Sally Beatty

+1-212-733-6566

Media (EU)

Lisa O'Neill

+44-1737-331536

Investor Relations

Ryan Crowe

+1-212-733-8160

SOURCE: Merck KGaA, Darmstadt, Germany