Putting the Patient First: Merck Serono to Present Data That Embodies the ESMO 2014 Theme of 'Precision Medicine in Cancer Care'

PR58039

DARMSTADT, Germany, Sep. 26 /PRN=KYODO JBN/ --

    Not intended for US- and UK-based media

    ESMO 2014 Abstract #: Physician biomarker survey: 1080O_PR; Erbitux:

CRYSTAL: 541P; LASCCHN: 993PD; DIRECT: 996P; Pipeline: pimasertib: 443O; c-Met:

1333TiP, 450PD, 744TiP, 745TiP; further pipeline: 772P, 507PD, 1235P

    - New research evaluates physicians' understanding of predictive

biomarkers  and perceptions of what patients themselves understand about

personalized medicine

    - Key data from analyses of Erbitux(R) (cetuximab) in RAS wild-type

metastatic colorectal cancer and in human papillomavirus p16+/p16-

locoregionally advanced SCCHN patient populations

    - Pipeline data on early-stage compounds targeting specific pathways

in       difficult-to-treat cancers

    Merck Serono, the biopharmaceutical division of Merck, today announced that

it will be presenting data at the European Society for Medical Oncology (ESMO)

2014 congress (Madrid, Spain, September 26-30, 2014) aligned with the congress

theme of 'Precision Medicine in Cancer Care'. 'Precision medicine', as defined

by ESMO 2014, involves providing optimal treatment for patients according to

their individual circumstances and the molecular characteristics of their

disease.[1]

    "Merck Serono believes in the principle of 'Precision Medicine'; it

underpins both our patient-centric approach and our commitment to identifying

those patients who would benefit most from our medicines," said Luciano

Rossetti, Head of Research and Development, Merck Serono. "The data at ESMO

2014 demonstrates how we put the patient first, and go beyond treatment to

support the delivery of focused cancer care, including biomarker testing."

    Physician and Patient Understanding of Biomarkers

    Findings from a Merck Serono-sponsored global survey of oncologists

(n=895)[2] from 12 countries (across Asia, Europe and South America) on their

use of predictive biomarkers in a range of late-stage and metastatic cancers

(lung, breast and colorectal [mCRC]) will be presented during an oral session

on Sunday, September 28, 11:00-12:20. The survey also includes physician

perceptions of patient understanding of biomarkers and treatment options.

    Results from the survey will also be included in an official ESMO 2014

press release and are under strict embargo until 11:00 CET on Sunday, September

28, 2014.

    Exploring Biomarkers in mCRC and SCCHN

    Retrospective subanalyses from two pivotal Phase III studies for Erbitux(R)

(cetuximab) will be presented as part of Merck Serono's continued effort to

further understand biomarkers that may help to inform treatment decisions. The

CRYSTAL* study subanalysis evaluates Erbitux plus FOLFIRI (folinic acid,

5-fluorouracil and irinotecan), compared with FOLFIRI alone, in patients with

RAS wild-type mCRC, as assessed by liver-limited disease (LLD) status. Further

data from the Bonner study assesses the prognostic value of p16 status (p16

positive and p16 negative), a marker of human papillomavirus, in patients with

locoregionally advanced squamous cell carcinoma of the head and neck (SCCHN).

    Pipeline Data: Targeting Specific Pathways

    Merck Serono is presenting data from its diversified early-stage pipeline

at ESMO 2014, underscoring the importance of targeting specific pathways. Data

include results in difficult-to-treat cancers, as well as in specific patient

populations. Highlights include: an oral presentation on results from a Phase

Ib study of pimasertib, a MEK inhibitor, in selected genotype-defined solid

tumors; pimasertib in combination with SAR245409, a PI3K/MTOR inhibitor; and a

number of studies of the highly selective c-Met inhibitor MSC2156119J (EMD

1214063), including a poster discussion of the first-in-human Phase I results

in patients with advanced solid tumors. Data will also be presented on

abituzumab (DI17E6, EMD 525797) an investigational anti-integrin monoclonal

antibody.

    Notes to Editors

    Abstracts related to Merck Serono studies with Erbitux and pipeline

compounds include:

    Erbitux

    Title: FOLFIRI plus cetuximab in patients liver-limited or

non-liver-limited RAS wild-type metastatic disease: A sub-group analysis of the

CRYSTAL study

    Lead author: C-H Kohne

    Abstract #: 541P

    Presentation date/time (CET): Sep 29, 12:45-13:45

    Session: Poster Display Session

    Room/details: Poster display area

    Title: Association of human papillomavirus (HPV) and p16 status with

efficacy and safety data in the Phase III radiotherapy (RT)/cetuximab (cet)

registration trial for locoregionally advanced squamous cell carcinoma of the

head and neck (LASCCHN)

    Lead author: JA Bonner

    Abstract #: 993PD

    Presentation date/time (CET): Sep 28, 13:00-14:00

    Session: Poster Discussion, Head and Neck Cancer

    Room/details: Bilbao

    Title: Cetuximab relative dose intensity (RDI) in recurrent/metastatic

(R/M) squamous cell carcinoma of the head and neck (SCCHN): First observational

prospective study in unselected patients (DIRECT trial)

    Lead author: J Guigay

    Abstract #: 996P

    Presentation date/time (CET): Sep 29, 12:45-13:45

    Session: Poster Display Session

    Room/details: Poster display area

    General oncology: Physician biomarker survey

    Title: Physicians' awareness and understanding of personalized medicine in

the treatment of cancer and its adoption in clinical practice: a multinational

survey

    Lead author: F Ciardiello

    Abstract #: 1080O_PR

    Presentation date/time (CET): Sep 28, 11:00-12:20

    Session: Proffered Papers, Issues Facing Oncologists Today

    Room/details: Alicante

    c-Met inhibitor, MSC2156119J

    Title: Phase Ib/II trial of c-Met inhibitor MSC2156119J and gefitinib vs

chemotherapy  as 2nd-line treatment in Asian patients with Met-positive (Met+),

locally advanced or metastatic non-small cell lung cancer (NSCLC) with

epidermal growth factor mutation (EGFRm+) and progression on gefitinib

    Lead author: K Park

    Abstract #: 1333TiP

    Presentation date/time (CET): Sep 27, 12:45-13:45

    Session: Poster Display Session

    Room/details: Poster display area

    Title: First-in-human Phase I trial assessing the highly selective c-Met

inhibitor MSC2156119J (EMD 1214063) in patients with advanced solid tumors

    Lead author: GS Falchook

    Abstract #: 450PD

    Presentation date/time (CET): Sep 28, 13:00-14:00

    Session: Poster Discussion Session, Developmental Therapeutics

    Room/details: Alicante

    Title: Met-positive advanced hepatocellular carcinoma and Child-Pugh class

A liver function in Asian patients: a randomized, multicenter, Phase Ib/II

trial of the oral c-Met inhibitor MSC2156119J vs sorafenib

    Lead author: S Qin

    Abstract #: 744TiP

    Presentation date/time (CET): Sep 29, 12:45-13:45

    Session: Poster Display Session

    Room/details: Poster display area

    Title: Phase Ib/II, multicenter, single-arm trial of the oral c-Met

inhibitor MSC2156119J as monotherapy in patients with Met-positive advanced

hepatocellular carcinoma with Child-Pugh class A liver function who failed

sorafenib treatment

    Lead author: S Faivre

    Abstract #: 745TiP

    Presentation date/time (CET): Sep 29, 12:45-13:45

    Session: Poster Display Session

    Room/details: Poster display area

    Pimasertib, a MEK inhibitor

    Title: Pimasertib (PIM) and SAR245409 (SAR) - a MEK and PI3K/MTOR inhibitor

combination: A Phase Ib trial with expansions in selected genotype-defined

solid tumors

    Lead author: RS Heist

    Abstract #: 443O

    Presentation date/time (CET): Sep 27, 14:00-15:45

    Session: Proffered Papers, Developmental Therapeutics, Oral Presentation

    Room/details: Cordoba

    Additional Pipeline Projects: Oncology

    Title: Abituzumab (DI17E6, EMD 525797) treatment for chemotherapy-naive

patients with asymptomatic or mildly symptomatic metastatic

castration-resistant prostate cancer (mCRPC): primary outcomes of the

placebo-controlled Phase 2 study PERSEUS (NCT01360840)

    Lead author: K Miller

    Abstract #: 772P

    Presentation date/time (CDT): Sep 27, 12:45-13:45

    Session: Poster Display Session

    Room/details: Poster display area

    Title: POSEIDON Phase I/II trial: abituzumab combined with cetuximab plus

irinotecan as  second-line treatment for patients with KRAS wild-type

metastatic colorectal cancer

    Lead author: E Elez

    Abstract #: 507PD

    Presentation date/time (CDT): Sep 27, 13:00-14:00

    Session: Poster Discussion Session, Gastrointestinal Tumors, Colorectal

    Room/details: Granada

    All early-stage products are currently under clinical investigation and

have not been approved for use in the U.S., Europe, Canada, or elsewhere. All

investigational products have not yet been proven to be either safe or

effective and any claims of safety and effectiveness can be made only after

regulatory review of the data and approval of the labeled claims.

    *CRYSTAL: Cetuximab combined with iRinotecan in first-line therapY for

metaSTatic colorectAL cancer

    References

    1) European Society for Medical Oncology 2014 Congress Page. Available at:

http://www.esmo.org/Conferences/ESMO-2014-Congress/Programme. Last accessed

September 2014.

    2) Ciardiello, F et al. Oral presentation at the European Society for

Medical Oncology Congress, 2014, September 28. Abstract No:1080O_PR.

    For more information on Merck Serono in oncology and immuno-oncology,

please visit: http://www.globalcancernews.com.

    About Erbitux

    Erbitux(R) is a first-in-class and 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 that seems to be correlated with a good response to therapy. 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 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. In

Japan, ImClone, Bristol-Myers Squibb Company and Merck jointly develop and

commercialize Erbitux. Merck has an ongoing commitment to the advancement of

oncology treatment and is currently investigating novel therapies in highly

targeted areas.

    About Merck Serono

    Merck Serono is the biopharmaceutical division of Merck. With headquarters

in Darmstadt, Germany, Merck Serono offers leading brands in 150 countries to

help patients with cancer, multiple sclerosis, infertility, endocrine and

metabolic disorders as well as cardiovascular diseases. In the United States

and Canada, EMD Serono operates as a separately incorporated subsidiary of

Merck Serono.

    Merck Serono discovers, develops, manufactures and markets prescription

medicines of both chemical and biological origin in specialist indications. We

have an enduring commitment to deliver novel therapies in our core focus areas

of neurology, oncology, immuno-oncology and immunology.

    For more information, please visit http://www.merckserono.com.

    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.

    Merck is a leading company for innovative and top-quality high-tech

products in the pharmaceutical and chemical sectors. With its four divisions

Merck Serono, Consumer Health, Performance Materials and Merck Millipore, Merck

generated total revenues of EUR 11.1 billion in 2013. Around 39,000 Merck

employees work in 66 countries to improve the quality of life for patients, to

further the success of our 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, Darmstadt, Germany is holding the global rights to the Merck name

and brand. The only exceptions are Canada and the United States, where the

company is known as EMD.

    SOURCE: Merck Serono