ROTTERDAM, Netherlands and SAN DIEGO, March 17, 2020 /PRNewswire/ -- SkylineDx shares research showing that multiple myeloma (blood cancer) patients with a high risk or aggressive course of the disease are unlikely to benefit from current treatment approaches, including lenalidomide mono-therapy for maintenance when compared to observation only. The Institute of Cancer Research (ICR) in London (UK), derived these results from the NCRI Myeloma XI trial with 329 patients and validated the findings in MRC Myeloma IX trial after which they published the findings in Nature Leukemia. The conclusion of the paper supports the use of so-called "molecular biomarkers" in the clinic to build a molecular profile of the patient's cancer to better guide the most effective treatment strategy at diagnosis .
The "aggressiveness" of the disease is measured with biomarkers per individual patient and translated into a standard-risk (normal course of the disease), a high-risk (progressive or more aggressive disease) and an ultrahigh-risk (fast progressive or most aggressive disease) profile. One of the biomarkers used is the MMprofiler with SKY92 algorithm. This biomarker reads the expression of 92 genes from the cancerous plasma cell and calculates if a patient is at high risk of progression, or in other words, if the cancer is more aggressive .
According to the published manuscript, the MMprofiler with SKY92 is independently able to predict the cancer's aggressiveness in newly diagnosed patients. In 24.6% of patients, the SKY92 high-risk biomarker was present, resulting in a significant shorter period until disease progression (median of 16 months versus 33.8 months for non-SKY92 high-risk patients) and a significantly reduced overall outlook (50% of these high-risk patients died within 36.7 months versus a median that was not reached at 60 months for non-SKY92 high-risk patients). These results are regardless of induction treatment and posttransplant treatment strategy. Furthermore, if a patient bears the SKY92 high-risk marker, lenalidomide as maintenance therapy does not give the patient a significant longer relapse free period or a better overall outlook. That means that a patient can obtain the same result by being closely observed without taking the medicine and suffer accompanying adverse reactions .
"The publication by this esteemed group of researchers and clinicians is the independent confirmation that molecular biomarkers like SKY92 need to be adopted in clinical practice to avoid true fast progressing high-risk patients being missed at diagnosis," comments Dharminder Chahal, CEO of SkylineDx that developed the MMprofiler with SKY92 algorithm. "It shows that SKY92 identifies an additional 12% of high-risk patients for whom this information is currently not available but would impact their treatment decision. These patients need to be informed since they could clearly follow a different clinical path," concludes Dharminder Chahal.
SkylineDx is a high-tech commercial-stage biotech company headquartered in Rotterdam, the Netherlands and a CAP/CLIA certified 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.
1. Link to press release on website SkylineDx (click here)
2. Shah, V., Sherborne, A.L., Johnson, D.C. et al. Predicting ultrahigh risk multiple myeloma by molecular profiling: an analysis of newly diagnosed transplant eligible myeloma XI trial patients. Leukemia (2020). https://doi.org/10.1038/s41375-020-0750-z