New Global Pooled Analysis Supports Clinical Utility of Circulating Tumor Cell Count for Early Monitoring of Metastatic Breast Cancer

Robust pooled analysis demonstrating how CTC count may help to optimize treatment choices

BOLOGNA,Italy and HUNTINGDON VALLEY,Pa.,Dec. 10,2020 -- Menarini Silicon Biosystems,a pioneer of liquid biopsy technology,today announced the results of a pooled analysis of 14 clinical trials on the relevance of circulating tumor cell (CTC) count to predict both disease prognosis and treatment efficacy in metastatic breast cancer (MBC). This global study,based on 4079 cases across all advanced breast cancer subtypes,is the largest pooled analysis to-date on the role of serial CTC count in the MBC setting. It included individual patient data and was selected for an oral presentation at the 2020 San Antonio Breast Cancer Symposium.

The analysis was led by Minetta C. Liu,MD,Professor and Research Chair for the Department of Oncology and Consultant in the Department of Laboratory Medicine & Pathology at Mayo Clinic in Rochester,Minnesota,USA and Prof. Prof,Dr med Wolfgang Janni,Professor of Obstetrics,Adult and Pediatric Gynecology of the University Hospital Ulm,Germany. According to Dr. Liu,"This pooled analysis represents an international collaboration including an unprecedented number of multi-institutional clinical trials conducted across Asia,Europe,and North America. Colleagues kindly provided de-identified,individual patient level data from prospective clinical studies published in the peer-reviewed literature to generate a dataset of over 4000 participants. This statistical power allowed us to achieve our main objective – namely,to further define and validate the role of CTC enumeration for early monitoring of disease status in patients with metastatic breast cancer,irrespective of subtypes defined by hormone receptor and HER2 status."

Data from this pooled analysis were gathered at baseline and then at a median of 29 days after treatment initiation.Detection,capture,isolation and phenotyping of tumor cells circulating in the blood in all patients was carried out with Menarini Silicon Biosystems' CELLSEARCH® CTC System. Results were determined by commonly used log rank and Cox regressions tests. The focus of these statistical analyses was on the association between serial CTC enumeration results and overall survival (OS) in the full patient cohort and defined subgroups. Subgroups included patients with hormone receptor positive,HER2 type and triple negative MBC as well patients whose breast cancer type was not specified. The conclusion across all groups is that patients whose CTC status is negative,both at baseline and follow-up,namely the reference group,have a median OS rate of 47.05 months compared to 17.87 months for those with a positive CTC status at both check points (p-value <0.0001). The importance of conducting follow-up analyses of patient CTCs is underlined by the data from all subgroups because they indicate that patients,whose CTC status went from positive to negative,had an OS of 32.2 months (HR 0.49,p-value <0.0001) an almost two-fold increase in the OS of patients whose CTC status remained positive.

"With the efficacy of novel therapies increasingly linked to the biological characteristics of a given tumor and the urgent need to continue to improve clinical interventions in the metastatic setting,this study strongly supports the potential of early CTC monitoring in all subtypes of MBC to optimize individual patient management along the treatment pathway and thereby improve patient outcomes," further commented Prof. Dr med Wolfgang Janni.

For Fabio Piazzalunga,President and CEO of Menarini Silicon Biosystems: "The results of this large and robust pooled analysis represent not only a major contribution to the expanding body of evidence aimed at validating the role of repeat CTC counts to optimize clinical interventions for the more difficult to treat MBC,they are also a testimony to the importance of developing more sophisticated prognostic/predictive approaches alongside new targeted therapies to reach the ultimate goal of improving both patient outcome and quality of life." As the pioneer in liquid biopsies,Menarini Silicon Biosystems is committed to developing its technology to help physicians identify appropriate treatment strategies in the challenging environment of heterogenous advanced breast cancers and growing number of therapeutic options from which to choose.

About CELLSEARCH

CELLSEARCH 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. The CELLSEARCH Systemis the most extensively studied CTC technology,with research published in more than 650 peer-reviewed publications.

For more information on the full intended use and limitations of the CELLSEARCH system,please refer to the Instructions for Use athttp://documents.cellsearchctc.com/.

About Menarini Silicon Biosystems

Menarini 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.

Contact: Linda Pavy - linda.pavy@bcw-global.com

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