SKY92 Gene Signature Facilitates Cost-effective, Risk-stratified Treatment of Multiple Myeloma

Poster Presentation at ISPOR European Congress Demonstrates Cost-savings and Health-Generating Benefits of SKY92

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Nov 13, 2017, 09:05 ET

ROTTERDAM, Netherlands and LAGUNA HILLS, Calif., Nov. 13, 2017 /PRNewswire/ -- SkylineDx announced new data from the 20^th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) in Glasgow, Scotland, that demonstrate the cost-savings and health-generating potential of MMprofiler™ with SKY92, the company's prognostic tool to risk-stratify patients with multiple myeloma (MM). This is the first study to examine the potential health economic value of risk-stratified treatment (RST) in MM within the European Union (EU).

"Despite a general trend toward increasing survival, treatment outcomes in multiple myeloma remain highly variable, making risk stratification an essential component of therapeutic decision-making," said Jennifer G. Gaultney, PhD, Senior Health Economics Consultant at IQVIA in London, UK. "The SKY92 gene signature is the most reliable prognostic biomarker in multiple myeloma for prediction of high risk patients with expected survival of less than two years, and its use appears to facilitate both cost-effective and outcomes-enhancing treatment of this devastating disease."

At the ISPOR Congress, Dr. Gaultney and colleagues presented a poster summarizing their cost-effectiveness analysis of data from the Phase III HOVON 65/GMMG-HD4 clinical trial. The analysis evaluated two different scenarios: one in which all patients are treated the same (uniform treatment, or UT), and one that uses a RST approach based on one or more risk biomarkers.

The investigators developed a decision analytic model that simulated the total costs and health benefits of UT versus RST for three risk categories: high risk, standard risk, and unknown risk (i.e., data were not available for one or more prognostic factors). For each country included in the analysis (the Netherlands, Germany, UK, France, and Spain), all RST scenarios dominated UT, with RST-SKY92 producing the greatest health gains compared to UT. In terms of cost-effectiveness, the greatest benefits of RST compared to UT were demonstrated in Germany and France.

"The data presented at ISPOR show how SKY92 facilitates early assessment of the circumstances under which risk-stratified treatment is beneficial in newly diagnosed patients with multiple myeloma," commented Dharminder S. Chahal, Chief Executive Officer of SkylineDx. "Although the data are specific to Europe, they are potentially transferable to other geographic areas, and support the rationale for risk-stratified therapeutic approaches in multiple myeloma."

About Multiple Myeloma

Multiple myeloma (MM) is a cancer that arises from plasma cells, a type of white blood cell made in the bone marrow. In patients with MM, the plasma cells become abnormal, multiply uncontrollably, and release only one type of antibody – known as M-protein – which has no useful function. According to the World Cancer Research Fund International, an estimated 114,000 people around the world are diagnosed with MM annually, and the disease represents 0.8% of all cancers globally.

For more information about MM, visit www.hematon.nl/myeloom (information available in Dutch only), www.themmrf.org, www.myeloma.org.uk, www.mpeurope.org, or www.myeloma.org.

About MMprofiler with SKY92

MMprofiler assesses risk by measuring the activity of 92 MM-related genes that comprise SKY92, SkylineDx's novel, prognostic gene classifier. The lead product of SkylineDx, MMprofiler is proven to be superior to the biomarkers currently used to risk-stratify newly diagnosed and relapsed multiple myeloma patients into a "high" or "standard" risk category.^{^[1]} Included in a growing number of international treatment guidelines, MMprofiler is CE-IVD registered in Europe and will be coming soon as a laboratory-developed test (LDT) in the United States. For more information, please visit www.mmprofiler.com.

About SkylineDx
SkylineDx is a commercial-stage biotech company based in Rotterdam, the Netherlands. Originally a spin-off of the Erasmus Medical Center in Rotterdam, the company specializes in the development and marketing of innovative gene signature-based prognostic tests to assist healthcare professionals in making personalized treatment decisions for individual patients. These tests are designed to accurately determine the type or status of the disease or to predict a patient's response to a specific treatment. Based on the test results, healthcare professionals can tailor the treatment to the individual patient. MMprofiler with SKY92 is the company's lead product. To learn more, please visit www.skylinedx.com.

Media Inquiries for SkylineDx
Jeffrey Jones, SkylineDx
949-303-8198
[email protected]

Kara Golub
609-456-0822
[email protected]

[1] Van Beers EH, van Vliet M, de Best L, et al. SKY92 GEP, iFISH, and ISS comparisons for risk stratification in multiple myeloma. Poster p661 presented at 20th European Hematology Association Congress, Vienna, Austria, June 13, 2015.

SOURCE SkylineDx