ROTTERDAM (the Netherlands) and SAN DIEGO (US), June 13th, 2019: a substantial number of blood cancer (multiple myeloma) patients could make more informed decisions on their treatment if more information becomes available for them and their treating physicians. Interim results of a clinical study, executed by 6 renowned US hospitals [1], show that a physician can improve diagnosis in 42% of cases by using a reliable, robust and standardized test that assigns a risk profile [2]. Evidence is building up that patients live longer and in better health when you treat low-, standard- and high-risk patients differently [3-4]. Furthermore, 79% of patients want to know their risk profile as this is directly linked to their prognosis [5]. The data demonstrates that the test would provide value to patients in standard clinical practice. For the diagnostic test to be adopted by international guidelines, it needs be reviewed by associations like ASCO, ESMO, IMWG and EMN.
“I would really appreciate having the SKY92 test available outside the clinical study in order to tailor my treatment decisions and offer my patients a more personalized prognostic outlook”, comments Parameswaran Hari, one of US’ foremost authorities on multiple myeloma, practicing physician and principal investigator in the above mentioned ongoing clinical study.
SKY92 is able to assign one of three risk profiles at the moment of diagnosis. Published data show that high-risk patients who won’t have a stem cell transplantation, appear to live longer when treated with lenalidomide (55 months) compared to thalidomide (17 months) [3]. Another study in favor of risk directed treatment was published last year. Standard of care for most patients is to undergo a stem cell transplantation. However, when a patient is low-risk, a non-transplant strategy gives them a better outlook (95% alive after 4 years versus 72%) and saves them a strenuous regimen. High-risk patients show improved outcomes on a transplant strategy (68% alive after 4 years versus 22%) [4].
“I am blown away by the interim results of our clinical study”, says Dharminder Chahal, CEO SkylineDx that developed the SKY92 test. “We now know that our test makes additional, crucial information available to patients and physicians in 42% of cases. We therefore must increase our efforts to make this test available to all multiple myeloma patients at an accelerated pace. In this pursuit I insist on collaboration with and from guideline committees, regulatory authorities and payors”, concludes Dharminder Chahal.
Footnotes
- Lombardi Comprehensive Cancer Center (Washington, Washington DC), Hackensack University Medical Center (Hackensack, New Jersey), Columbia University Medical Center (New York, New York), Weill Cornell Medicine (New York, New York), Levine Cancer Institute (Charlotte, North Carolina) and Medical College of Wisconsin (Milwaukee, Wisconsin).
- Hari, et al. 2019. EHA Abstract PF620 (link). Poster presentation at EHA on Friday, June 14, 2019 from 5.30-7PM, poster area. Amsterdam RAI Exhibition and Convention Centre, Amsterdam, The Netherlands.
- Kuiper, et al. 2019. EHA Abstract PS1374 (link). Poster presentation at EHA on Saturday, June 15, 2019 from 5.30-7PM, poster area. Amsterdam RAI Exhibition and Convention Centre, Amsterdam, The Netherlands.
- Hofste op Bruinink, et al. 2018. ASH Abstract 3186.
- To be published later in addition to Van Dongen – Leunis, et al. 2019. EHA Abstract PF727 (link). Poster presentation at EHA on Friday, June 14, 2019 from 5.30-7PM, poster area. Amsterdam RAI Exhibition and Convention Centre, Amsterdam, The Netherlands.
About SkylineDx
SkylineDx is a high-tech commercial-stage biotech company headquartered in Rotterdam, The Netherlands and a commercial office and laboratory in San Diego, California, USA. The company uses its expertise to bridge the gap between academically discovered gene expression signatures and commercially available diagnostic products with high clinical utility. With the focus on diagnostics, SkylineDx assists healthcare professionals in accurately determining 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. To learn more, please visit www.skylinedx.com.
