Merck to Present New Research Focused on Hard-to-Treat Cancers at ESMO 2016

PR65925

DARMSTADT, Germany, Sept. 28, 2016 /PRNewswire=KYODO JBN/

     Not intended for UK- or US-based media  

    ESMO Abstract #

    Avelumab: 777PD, 775PD, 1154P, 842TiP, 844TiP; Erbitux: 527P, 491P, 967P,

994P; Tepotinib: 1257P, 1287TiP, 1292TiP

    Merck to feature new research from marketed and pipeline compounds  

Preliminary results from combination study with avelumab in renal cell

carcinoma, and updates on Phase II tepotinib program in

non-small cell lung cancer, to be presented  

Merck to announce 2016 Grant for Oncology Innovation winners coinciding with

ESMO

    Merck, a leading science and technology company, today announced that new

research from their marketed and pipeline compounds will be presented at this

year's European Society for Medical Oncology (ESMO; October 7-11, 2016,

Copenhagen, Denmark) annual meeting. Presentations will focus on hard-to-treat

cancers, and include: study results for Erbitux（R） (cetuximab) in metastatic

colorectal cancer (mCRC) and squamous cell carcinoma of the head and neck

(SCCHN); preliminary study results in bladder cancer and renal cell carcinoma

(RCC) for avelumab, which is being developed in collaboration with Pfizer; and

updates on the Phase II program for tepotinib* in non-small cell lung cancer

(NSCLC).

    "The data being presented at ESMO reflect our commitment to making a

meaningful difference in patients' lives, in particular those who are affected

by hard-to-treat cancers," said Luciano Rossetti, Executive Vice President,

Head of Global Research & Development at the biopharma business of Merck. "We

continue to focus on researching the full potential of Erbitux, as well as our

ongoing pipeline development programs for avelumab and other early-stage

oncology and immuno-oncology compounds."

    At ESMO, avelumab will be featured in four posters that add to the growing

body of evidence of the potential of this investigational compound. These will

include data updates in bladder cancer that confirm avelumab's potential in

this hard-to-treat cancer; and preliminary results from a combination study

with axitinib in RCC that support the rationale to evaluate the combination in

a Phase III pivotal study. Tepotinib, a highly selective c-Met kinase

inhibitor, will also be highlighted in three posters, with updates on the

ongoing study program in c-Met-positive metastatic NSCLC.

    Several studies, which will be presented at ESMO, once again reaffirm

Erbitux as a standard-of-care therapy for mCRC patients with RAS wild-type

tumors and patients with SCCHN.

    Merck believes that to truly deliver the promise of innovation for

patients, it is vital to support and encourage research from other endeavors.

This is demonstrated through Merck's Grant for Oncology Innovation (GOI)

initiative, which awards researchers for their pioneering independent work in

pushing the boundaries of creativity and science in order to deliver

transformative innovation. The award ceremony will once again coincide with

ESMO and takes place on Sunday, October 9, 2016.

    *Tepotinib is the proposed nonproprietary name for the c-Met kinase

inhibitor (also known as MSC2156119J).

    Avelumab and tepotinib are under clinical investigation and have 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.

    Notes to Editors

    Accepted Merck-supported abstracts are listed below. In addition, a number

of investigator-sponsored studies have been accepted, including several related

to Erbitux (not listed).

    Erbitux

    Title: Impact of tumor epidermal growth factor receptor (EGFR) status on

the outcomes of first-line FOLFOX-4 ± cetuximab in patients (pts) with

RAS-wild-type (wt) metastatic colorectal cancer (mCRC) in the randomized phase

3 TAILOR trial

Lead Author: S Qin

Abstract #: 527P

Presentation date/time (CDT): October 8, 13:00-14:00

Session: Poster Display Session

Room/Details: Hall E

    Title: Impact of surgical resection of liver metastases on outcome of

patients with metastatic colorectal carcinoma (mCRC) treated with a

cetuximab-based first-line therapy - Analysis of the KRAS-wildtype exon 2

(KRAS-wt) subgroup of the German non-interventional study ERBITAG

Lead Author: U Neumann

Abstract #: 491P

Presentation date/time (CDT): October 8, 13:00-14:00

Session: Poster Display Session

Room/Details: Hall E

    Title: Observational study of the dose intensity relative to cetuximab in

the first-line treatment of recurrent and/or metastatic squamous cell carcinoma

of the head and neck: data on the maintenance and bi-weekly use (DIRECT study)

Lead Author: J Guigay

Abstract #: 967P

Presentation date/time (CDT): October 9, 13:00-14:00

Session: Poster Display Session

Room/Details: Hall E

    Title: Cetuximab in combination with platinum-based chemotherapy or

radiotherapy in recurrent and/or metastatic SCCHN in a non-selected patient

cohort (interim analysis of the phase IV SOCCER trial)

Lead Author: M Hecht

Abstract #: 994P

Presentation date/time (CDT): October 9, 13:00-14:00

Session: Poster Display Session

Room/Details: Hall E

    Avelumab

    Title: Avelumab (MSB0010718C; anti-PD-L1) in patients with metastatic

urothelial carcinoma progressed after platinum-based therapy or platinum

ineligible

Lead Author: M Patel

Abstract #: 777PD

Presentation date/time (CDT): October 9, 16:30-17:30

Session: Poster Discussion Session Genitourinary tumors, non-prostate

Room/Details: Athens

    Title: Phase 1b dose-finding study of avelumab (anti-PD-L1) + axitinib in

treatment-naive patients with advanced renal cell carcinoma

Lead Author: J Larkin

Abstract #: 775PD

Presentation date/time (CDT): October 9, 16:30-17:30

Session: Poster Discussion Session Genitourinary tumors, non-prostate

Room/Details: Athens

    Title: Evaluation of real world treatment outcomes in patients with

metastatic Merkel cell carcinoma (MCC) following second line chemotherapy

Lead Author: J Becker

Abstract #: 1154P

Presentation date/time (CDT): October 9, 13:00-14:00

Session: Poster Display Session

Room/Details: Hall E

    Title: A multicenter, international, randomized, open-label phase 3 trial

of avelumab + best supportive care (BSC) vs BSC alone as maintenance therapy

after first-line platinum-based chemotherapy in patients with advanced

urothelial cancer (JAVELIN Bladder 100)

Lead Author: T Powles

Abstract #: 842TiP

Presentation date/time (CDT): October 9, 13:00-14:00

Session: Poster Display Session

Room/Details: Hall E

    Title: Phase 3 study of avelumab in combination with axitinib versus

sunitinib as first-line treatment for patients with advanced renal cell

carcinoma (aRCC)

Lead Author: R Motzer

Abstract #: 844TiP

Presentation date/time (CDT): October 9, 13:00-14:00

Session: Poster Display Session

Room/Details: Hall E

    Tepotinib

    Title: Tepotinib plus gefitinib in patients with c-Met-positive/EGFR-mutant

NSCLC: recommended phase II dose (RP2D), tolerability, and efficacy

Lead Author: Y-L Wu

Abstract #: 1257P

Presentation date/time (CDT): October 8, 13:00-14:00

Session: Poster Display Session

Room/Details: Hall E

    Title: Design of a phase II trial comparing tepotinib + gefitinib with

cisplatin + pemetrexed in EGFR inhibitor-resistant, c-Met+ NSCLC

Lead Author: Y-L Wu

Abstract #: 1287TiP

Presentation date/time (CDT): October 8, 13:00-14:00

Session: Poster Display Session

Room/Details: Hall E

    Title: A phase II trial investigating the highly selective c-Met inhibitor

tepotinib in stage IIIB/IV lung adenocarcinoma with MET exon 14 alterations

after failure of at least one prior therapy

Lead Author: P Paik

Abstract #: 1292TiP

Presentation date/time (CDT): October 8, 13:00-14:00

Session: Poster Display Session

Room/Details: Hall E

＜end_indent＞

    For further information and press materials please visit

http://www.merckgroup.com/media-center-oncology.

    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.

    About Avelumab  

    Avelumab (also known as MSB0010718C) is an investigational, fully human

antibody specific for a protein found on tumor cells called PD-L1, or

programmed death ligand-1. Avelumab is thought to have a dual mechanism of

action which may enable the immune system to find and attack cancer cells. 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 is also thought to help white blood cells such

as natural killer (NK) cells find and attack tumors in a process known as ADCC,

or antibody-dependent cell-mediated cytotoxicity. In November 2014, Merck and

Pfizer announced a strategic alliance to co-develop and co-commercialize

avelumab.

    About Erbitux

    Erbitux（R） is a highly active IgG1 monoclonal antibody targeting the

epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of

action of Erbitux is distinct from standard non-selective chemotherapy

treatments in that it specifically targets and binds to the EGFR. This binding

inhibits the activation of the receptor and the subsequent signal-transduction

pathway, which results in reducing both the invasion of normal tissues by tumor

cells and the spread of tumors to new sites. It is also believed to inhibit the

ability of tumor cells to repair the damage caused by chemotherapy and

radiotherapy and to inhibit the formation of new blood vessels inside tumors,

which appears to lead to an overall suppression of tumor growth.

    The most commonly reported side effect with Erbitux is an acne-like skin

rash. In approximately 5% of patients, hypersensitivity reactions may occur

during treatment with Erbitux; about half of these reactions are severe.

    Erbitux has already obtained market authorization in over 90 countries

world-wide for the treatment of colorectal cancer and for the treatment of

squamous cell carcinoma of the head and neck (SCCHN). Merck licensed the right

to market Erbitux outside the US and Canada from ImClone LLC, a wholly-owned

subsidiary of Eli Lilly and Company, in 1998. Merck has an ongoing commitment

to the advancement of oncology treatment and is currently investigating novel

therapies in highly targeted areas.

    About Tepotinib

    Tepotinib (also known as MSC2156119J) is an investigational small-molecule

inhibitor of the c-Met receptor tyrosine kinase capable of inhibiting both

hepatocyte growth factor-dependent and -independent c-MET activation in low

nanomolar concentrations. Alterations of the c-Met signaling pathway are found

in various cancer types and correlate with aggressive tumor behavior and poor

clinical prognosis. Tepotinib is currently under evaluation in Phase I/II

trials.

    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 2015, Merck generated sales of EUR 12.85 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. The only exceptions are the United States and Canada, where the

company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.

     (Logo: http://photos.prnewswire.com/prnh/20160524/371574LOGO )

SOURCE: Merck