Merck to Collaborate with Sysmex Inostics on a Blood-Based RAS Biomarker Test

Merck to Collaborate with Sysmex Inostics on a Blood-Based RAS Biomarker Test

  PR Newswire

  DARMSTADT, Germany, June 1, 2014

DARMSTADT, Germany, June 1, 2014 /PRNewswire/ --

  *Development and commercialization agreement on blood-based RAS biomarker
    mutation status test for (metastatic) colorectal cancer (mCRC) 
  *This non-invasive, fast and easy-to-perform diagnostic test is expected to
    provide a real-time reflection of a patient's RAS mutation status to help
    guide clinical decision making in mCRC 

Merck announced today that the company has signed an agreement to collaborate
with Sysmex Inostics GmbH, Hamburg, Germany, for the development and
commercialization of a blood-based RAS biomarker test for patients with
metastatic colorectal cancer (mCRC). This global agreement was formally signed
at a ceremony coinciding with the 50th Annual Meeting of the American Society
of Clinical Oncology (ASCO) in Chicago, U.S.

 (Photo: http://photos.prnewswire.com/prnh/20140601/689906 )

Blood-based biomarker testing is a faster and easier approach for determining
the mutation status of tumors as it requires a small blood sample rather than
a tissue biopsy procedure. ^[ ^1 ^] The test has the potential to provide
mutation status results within days, which in turn can help guide treatment
decisions. ^[ ^1 ^] In addition, it may become the method of choice where a
tissue biopsy is difficult to obtain, for example in patients whose physical
condition does not allow for a surgical procedure.

"We are delighted to announce our strategic partnership with Sysmex Inostics,"
said Belén Garijo, President and CEO of Merck Serono. "As a company, we have
embraced the principles of personalized medicine and predictive biomarkers.
This collaboration reflects our commitment to leveraging our expertise in
personalized medicine and predictive biomarkers in order to enhance Erbitux's
value proposition for patients, physicians and payers."

"We are looking forward to this important collaboration with Merck Serono and
to bringing our innovative technology to mCRC patients," said Fernando Andreu,
CEO of Sysmex Inostics. "Together, with our non-invasive, blood-based
diagnostics and Merck's expertise in personalized medicine, we will open up
new possibilities to advance biomarker testing in mCRC. This collaboration is
another major step in enhancing the clinical value of Sysmex Inostics's
OncoBEAM tests and exemplifies Sysmex's overall strategy to bring sensitive
blood-based testing to the oncology field."

A biomarker test is a simple way of looking at the type and status of
particular genes of interest in a cancer. ^[ ^2 ^] ^, ^[ ^3 ^] Biomarkers have
been found for many different types of cancer such as colorectal, breast and
lung cancer, and have an increasingly important role in helping physicians to
tailor care and treatment for their patients, known as 'personalized
medicine'. ^[ ^2 ^- ^4 ^] RAS − a predictive biomarker − is a group of genes
that includes KRAS and NRAS and can be used to help select the most
appropriate therapy for each individual mCRC patient. ^[ ^5−9 ^] Currently,
biomarker testing has been performed with tissue taken directly from the tumor
itself, requiring an invasive biopsy, to ensure that the genes from the tumor
can be isolated. However, recent technological advances embraced by Sysmex
using blood samples allows very small amounts of circulating tumor DNA to be
isolated and tested.

"In mCRC, RAS has been identified as a key biomarker that can help predict how
well mCRC patients may respond to particular treatments, making it important
to know their RAS status as early as possible," commented Professor Sabine
Tejpar, Digestive Oncology Unit, University Hospital Gasthuisberg, Leuven,
Belgium. "As this test is potentially faster and easier to perform, this could
mean quicker and more timely treatment decisions − supporting the ultimate
goal of improved outcomes for patients."

Approximately half of patients with mCRC have RAS wild-type tumors and half
have RAS mutant tumors. ^[ ^10 ^] Results from studies assessing RAS mutation
status in patients with mCRC have shown that anti-epidermal growth factor
receptor (EGFR) monoclonal antibody therapies, such as Erbitux ^® (cetuximab),
can improve outcomes in patients with RAS wild-type mCRC. ^[ ^5 ^- ^9 ^]

About Colorectal Cancer 

Colorectal cancer (CRC) is the second most common cancer worldwide, with an
estimated incidence of more than 1.36 million new cases annually. ^[ ^11 ^] An
estimated 694,000 deaths from CRC occur worldwide every year, accounting for
8.5% of all cancer deaths and making it the fourth most common cause of death
from cancer. ^[ ^11 ^] Almost 55% of CRC cases are diagnosed in developed
regions of the world, and incidence and mortality rates are substantially
higher in menthan in women. ^[ ^11 ^]

References 

1.Diaz LA and Bardelli A. J Clin Oncol. 2014;32(6):579−86.
2.Moorcraft SY, et al. Therap Adv Gastroenterol 2013;6(5):381-95.
3.Ong FS, et al. Expert Rev Mol Diagn 2012;12(6):593-602.
4.Mallman MR, et al. EPMA J 2010;1(3):421-37.
5.Douillard J-Y, et al. N Engl J Med 2013;369(11):1023-34.
6.Schwartzberg LS, et al. J Clin Oncol 2014; March 31 [Epub ahead of print].
    Available online: http://www.ncbi.nlm.nih.gov/pubmed/24687833 . Last
    accessed April 2014.
7.Bokemeyer C, et al. Oral presentation at the 2014 American Society of
    Clinical Oncology Annual Meeting, May 30-June 3, 2014.
8.Stintzing S, et al. European Cancer Congress 2013:Abstract No:LBA17.
9.Ciardiello F, et al. Oral presentation at the 2014 American Society of
    Clinical Oncology Annual Meeting, May 30-June 3, 2014.
10.Vaughn CP, et al. Genes Chromosomes Cancer. 2011;50(5):307−12.
11.Ferlay J, Soerjomataram I, Ervik M, Dikshit R, Eser S, Mathers C, Rebelo
    M, Parkin DM, Forman D, Bray, F. GLOBOCAN 2012 v1.0, Cancer Incidence and
    Mortality Worldwide: IARC CancerBase No. 11 [Internet]. Lyon, France:
    International Agency for Research on Cancer; 2013. Available at:
    http://globocan.iarc.fr . Last accessed April 2014.



Notes to Editors

For more information on predictive biomarkers in colorectal cancer, please
visit: http://www.globalcancernews.com .

About Sysmex Inostics 

Sysmex Inostics, a subsidiary of Sysmex Corporation, is a molecular diagnostic
company whose core competency is mutation detection utilizing highly sensitive
technologies such as Plasma-Sequencing and BEAMing. With BEAMing being one of
the most sensitive and quantitative technologies available today for the
detection of tumor specific somatic mutations in blood samples, Sysmex
Inostics' BEAMing services are readily available to support clinical trials
and research in oncology. Furthermore, Sysmex Inostics companion diagnostics
(CDx) team offers services for the development of non-invasive plasma DNA
based IVD tests supported by a growing network of partners to cover the entire
IVD development process. In addition, BEAMing tests (OncoBEAM) are available
through a CLIA certified laboratory for routine clinical analysis.

Sysmex Inostics' headquarters are located in Hamburg, Germany and Sysmex
Inostics' Clinical Laboratory is located in Baltimore, Maryland. For more
information on OncoBEAM blood testing and the BEAMing technology refer to
http://www.sysmex-inostics.com or email info@sysmex-inostics.com .

About Erbitux 

Erbitux ^® 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 

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 €11.1 billion in 2013. Around 38,000 Merck
employees work in 66 countries to improve the quality of life for patients, to
further 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 percent 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.

Contact: Contact: Gangolf Schrimpf, Phone +49-6151-72-9591
 
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