AsiaNet 87145

BOLOGNA, Italy and HUNTINGDON VALLEY, Pa., December 9, 2020, /PRNewswire=KYODO JBN/--

Menarini Silicon Biosystems [http://www.siliconbiosystems.com/ ], 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 4 079 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

[https://www.mayo.edu/research/faculty/liu-minetta-c-m-d/bio-1003186 ],

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

[https://bookinghealth.com/university-hospital-ulm/departments/228419-department

-of-obstetrics-and-gynecology.html ], 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(R) 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 System [http://www.cellsearchctc.com/ ] is 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 at

http://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 [http://www.siliconbiosystems.com/ ], based in

Bologna, Italy, and Huntingdon Valley, Pa., U.S., is a wholly owned subsidiary

of the Menarini Group, a multinational pharmaceutical, biotechnology and

diagnostics company headquartered in Florence, Italy, with more than 17,000

employees in 140 countries.

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

Logo - https://mma.prnewswire.com/media/1362208/Menarini_Logo.jpg

SOURCE: Menarini Silicon Biosystems