From biopsies to blood-based testing
DARMSTADT, Germany—In pursuit of a new diagnostic test for colorectal cancer patients, Merck Serono and Hamburg, Germany-based Sysmex Inostics GmbH have established a collaborative agreement to develop and commercialize a blood-based RAS biomarker test for patients with metastatic colorectal cancer (mCRC).
“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,” said Prof. Sabine Tejpar of the Digestive Oncology Unit at University Hospital Gasthuisberg. “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.”
Roughly half of mCRC patients present with RAS wild-type tumors, with the other half presenting with RAS mutant tumors. Studies have demonstrated that anti-epidermal growth factor receptor monoclonal antibody therapies such as Erbitux, which is indicated for the treatment of colorectal cancer and head and neck cancer, have shown to be capable of improving outcomes in patients with RAS wild-type tumors.
“We are looking forward to this important collaboration with Merck Serono and to bringing our innovative technology to mCRC patients,” Fernando Andreu, CEO of Sysmex Inostics, commented in a statement. “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’ OncoBEAM tests and exemplifies Sysmex’s overall strategy to bring sensitive blood-based testing to the oncology field.”
This is the second collaboration between the Merck group and Sysmex, says Belén Garijo, president and CEO of Merck Serono, with the first having been announced in March between Sysmex and Merck Millipore with a focus on personalized medicine. Under this latest collaboration, Sysmex Inostics will develop diagnostic tests based on its BEAMing technology, which can enable a highly sensitive analysis of circulating tumor DNA shed into the bloodstream, providing a non-invasive alternative to biopsies in efforts to establish the mutational status of a tumor. The collaboration, Garijo says, will also leverage Merck Serono’s expertise in personalized medicine and predictive biomarkers.
It is Sysmex’s technological expertise, Garijo tells DDNews, that made them such an attractive partner for this work, noting that the company’s BEAM technology “is considered the gold standard in blood-based biopsies for detecting gene mutations in cancer.”
“Sysmex has already successfully demonstrated concordance between tissue- and blood-based testing in metastatic breast cancer and non-small cell lung cancer through the studies they have conducted,” Garijo continues. “Similar studies will now be performed in metastatic colorectal cancer. Besides the technological expertise, Sysmex has the passion to make life-changing improvements in the management of cancer patients. Like Merck Serono, they have a patient-centric approach, making us natural partners.”
A blood- based diagnostic test such as the one the companies aim to develop could make biomarker testing a great deal easier and less painful for patients, according to Garijo. Blood-based testing is a routine procedure and negates the need for painful biopsies, which are the current method of biomarker testing. In addition, he notes, it “has the potential to reflect the real-time tumor mutation status of a patient, as well as having a lower turnaround time for results,” as the test Merck Serono and Sysmex are developing “has the potential to provide mutation status results within days.”
Merck licensed marketing rights for Erbitux outside of the United States and Canada from ImClone LLC, a wholly owned subsidiary of Eli Lilly and Co., in 1998. Merck, ImClone and Bristol-Myers Squibb jointly develop and commercialize the drug in Japan.
Colorectal cancer currently ranks as the second most common cancer worldwide, with roughly 1.36 million new cases and 694,000 deaths worldwide each year. Some 8.5 percent of all cancer deaths are due to colorectal cancer, making this subtype the fourth most common cause of cancer-related death.