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