Menarini Silicon Biosystems announces new study results on use of CELLSEARCH® liquid biopsy for earlier detection of relapse and to help inform decisions on patient management in stage III Melanoma

Results of this MD Anderson study were recently published in Cancers and indicate the relevance of enumeration of Circulating Tumor Cells (CTCs) with the minimally invasive liquid biopsy-based CELLSEARCH®system to gain significantly earlier information,compared to standard imaging techniques,on the evolution of advanced skin cancer.

BOLOGNA,Italy and HUNTINGDON VALLEY,Pa.,Oct. 3,2023 --Menarini Silicon Biosystems,a pioneer of liquid biopsy technology,announced today the publication,in the peer-reviewed journal Cancers,of the results of a clinical study on the utility of CTCs to detect disease relapse substantially earlier than what is currently possible with routine surveillance imaging,in patients with stage III melanoma. This study included 325 patients who were mainly enrolled upon diagnosis of their stage III melanoma status. Blood was collected at different time points to detect CTCs and results were compared with follow-up imaging,to detect disease recurrence. The Menarini Silicon Biosystems CELLSEARCH system and Celltracks®Circulating Melanoma Cell Kit* were used to analyze and enumerate CTCs.

According to Dr. Anthony Lucci,MD,Professor of Surgery in the Department of Surgical Oncology at the University of Texas MD Anderson Cancer Center: "In this study we were able to detect CTCs in over 75% of patients… at a median of nine months prior to a radiological relapse". This data suggests that a blood biomarker is now able to help assess which patients with melanoma are most at risk of experiencing a relapse. "In the future these findings could lead to earlier intervention before a clinical metastasis is formed."

Melanoma is an aggressive cancer with both a propensity to spread to distant sites and poor prognosis when diagnosed at a late stage. Its prevalence has been increasing worldwide[1]. Despite the introduction of new targeted treatments and immunotherapies in the last decade,the risk of relapse continues to represent a major concern. The need,to improve the selection of high-risk patients who can most benefit from new immunotherapies and earlier intervention,is therefore quite urgent.

The overall study cohort was comprised of 174 males (53.5%) and 151 females (46.5%),with a mean age of 54.3 years (range,20–89 years).CTCs could,in 75% of cases,be identified many months prior to positive radiologic detection of disease relapse. Importantly,CTCs were detected at a median greater than 9 months before the radiological detection of progression,meaning that there is significant lead time available for treatment intervention. Moreover,patients,who had zero CTCs in their blood,were significantly less likely to develop disease relapse compared to those who had a presence of at least 1 CTC (HR: 0.37,95% CI: 0.26–0.53,p-value < 0.001). This study opens the door to both an earlier detection of disease progression,compared to the current standard of care imaging modalities including PET/CT,MRI,CT or ultrasound,and better timing for the utilization of imaging techniques that are more expensive and represent a higher burden to patients and to the healthcare system. The study results further underline the fact that the CELLSEARCH CTC liquid biopsy test could be used not only to guide earlier intervention but also to regularly monitor patient response to medication.

"We are thrilled by the fact that our CELLSEARCH technology has proven its value to guide early clinical intervention in a disease with a high unmet medical need," said Fabio Piazzalunga,President and CEO of Menarini Silicon Biosystems. "This study is another example of why we are socommitted to working with clinical research teams in different oncology settings where our minimally invasive and cost-effective CELLSEARCH platform keeps demonstrating an ability to address unmet healthcare needs".

About stage III melanoma

Stage III melanoma is a form of skin cancer in which cancer cells have spread to the lymph nodes that are located throughout the body. The primary cause of melanoma is exposure to UV radiation from the sun. People with fair skin are more susceptible to developing this disease because they have less melanin,the pigment that gives the skin its color and,also,acts as a UV shield. Because melanoma is the deadliest form of skin cancer with survival rates dropping significantly after metastasis,early diagnosis is key to improve prognosis.About CELLSEARCHCELLSEARCH is the first and only clinically validated blood test cleared by the U.S. Food & Drug Administration (FDA) for detecting and counting CTCs to aid physicians in managing patients with metastatic breast,prostate,and colorectal cancers when used in conjunction with other clinical methods of monitoring. The test is also approved by the China National Medical Products Administration (NMPA) for use in monitoring patients with Metastatic Breast Cancer. For more information on the full intended use and limitations of the CELLSEARCH system,please refer to the Instructions for Use at http://documents.cellsearchctc.com/.The Celltracks Circulating Melanoma Cell Kit* immunomagnetically captures CD146-positive cells from whole blood. Circulating melanoma cells are further identified using fluorescently labeled antibodies anti-MEL,anti-CD34,and anti-CD45. Circulating melanoma cells are defined as CD146+,MEL+,CD45-,CD34-.The Celltracks Circulating Melanoma Cell Kit is available as a Research Use Only product in Europe and Asia Pacific.In the USA only,the Celltracks Circulating Melanoma Cell test is available to clinicians,through Menarini Silicon Biosystems' CLIA registered clinical laboratory as a laboratory developed test.About Menarini Silicon BiosystemsMenarini Silicon Biosystems offers unique rare cell technologies and solutions that provide clinical researchers with access to unparalleled resolution in the study of cells and their molecular characterization.Menarini Silicon Biosystems,based in Bologna,Italy,andHuntingdon Valley,U.S.,is a wholly owned subsidiary of the Menarini Group,a multinational pharmaceutical,biotechnology and diagnostics company headquartered inFlorence,with more than 17,000 employees in 140 countries.*The Celltracks® Circulating Melanoma Cell Kit is for research use only and is not FDA cleared or approved for use to guide treatment decisions.[1]Wada-Ohno M,Ito T,Furue M. Adjuvant Therapy for Melanoma. Curr Treat Options Oncol. 2019 Jun 24;20(8):63. doi: 10.1007/s11864-019-0666-x. PMID: 31236710.CONTACT: Linda PAVY,lipavy@pavyconsulting.com