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

DARMSTADT, Germany, June 3, 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.

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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.